LAWON GENERAL USE PRODUCTS("Off. Herald of RS", Nos. 25/2019 and 14/2022) |
GENERAL USE PRODUCTS
Article 1
This Law shall regulate the notion of products of general use, compliance with the health i.e. safety requirements, which the products of general use supplied to the market must fulfill, for the purpose of ensuring a high level of protection of human life and health and the environment, protection of consumers’ interest and ensuring free movement of goods.
Provisions of this Law shall additionally pertain to raw materials, materials and additives used to produce products of general use, in compliance with this Law and regulations governing the above mentioned fields.
Article 2
The rules determined by this Law shall apply to:
1) The supervision system of the compliance with the health i.e. safety requirements, i.e. conformity of the products of general use with the prescribed requirements,
2) The laboratory testing of the compliance with the health i.e. safety requirements, i.e. conformity of the products of general use with the prescribed requirements,
3) The rights, obligations and responsibilities of the operators in the business of general use products.
Article 3
This Law shall apply to the products of general use intended for human use:
1) Which are produced in the Republic of Serbia and supplied to the market of the Republic of Serbia,
2) Which are imported and supplied to the market of the Republic of Serbia,
3) Which are exported and are on the market of the Republic of Serbia,
4) Which are imported or temporarily imported for the purpose of processing, finishing and treatment.
This Law shall not apply to products of general use which are exported and not placed on the market of the Republic of Serbia, with manufacturer’s proof of export.
Groups of Products of General Use
Article 4
The products of general use, within the meaning of this Law, shall include:
1) Materials and articles intended to come in contact with food, including products intended for babies and children under the age of three intended to facilitate feeding and sucking, relaxation and sleep and the packaging,
2) Toys,
3) Cosmetic products,
4) Materials and objects that, when used, come into direct contact with skin i.e. mucous membranes, irrespective of whether the integrity thereof is impaired or not,
5) Detergents, biocides and other agents for general use and maintenance of hygiene,
6) Tobacco, tobacco products, accessories for the use of tobacco products, electronic cigarettes and other systems for vapor inhalation with or without nicotine.
Gender Neutrality of the Terms
Article 5
The terms used in this Law in grammatical masculine gender shall include the natural male and female gender of the persons to which they pertain.
Article 6
Terms used in this Law shall have the following meanings:
1) Babies shall be the underage children of the age up to 12 months,
2) Young children shall be the underage persons of the age from 12 months to three years,
3) Children shall be the underage persons of the age from three to 14 years,
4) Manufacture of products of general use shall include preparation, treatment, processing, finishing, assembly, packing, storage of the products with the manufacturer,
5) Circulation of the products of general use shall include transportation, storage, use of the products of general use in provision of services, as well as any other method of the supply thereof to the market, irrespective of whether the profit is gained or not, including the importation or exportation thereof,
6) Supply to the market (making available on the market) shall mean each supply of the products of general use in the territory of the Republic of Serbia for the purpose of: distribution, consumption or use, in the course of a commercial activity, with or without consideration,
7) Placing on the market shall mean the initial supply of the products of general use to the market of the Republic of Serbia,
8) Recall shall mean any measure aimed at returning of a product that has already been made available to end user,
9) Withdrawal shall mean any measure aimed at preventing the product in the supply chain to become available on the market of the Republic of Serbia,
10) Traceability shall mean the possibility to trace a product of general use, a raw material or a substance intended for production of the products of general use or which may be incorporated in a product of general use, through all stages of production, processing and circulation,
11) Business including the products of general use shall mean any public or private activity performed in any stage of production or circulation of products of general use, irrespective of whether any profit has been gained or not,
12) Operator in business that includes products of general use shall mean a legal person, sole trader or natural person responsible for compliance with the legal requirements for the business operations in production and circulation, including the service provision activity relating to the use of the products of general use,
13) Health i.e. safety compliance of products of general use shall mean that the they are compliant with the requirements of this Law and other regulations in respect of the organoleptic properties, composition, type and contents of the harmful ingredients, information on the product, microbiological safety (where applicable), as well as that they do not pose risk to human health and the environment,
14) Official control shall mean the control of compliance with the health i.e. safety requirements of the products of general use in all stages of production and circulation, inspection sampling, monitoring program, as well as supervision of conducting of internal control,
15) Internal control shall mean the self-control procedure whereby a business operator checks compliance of its business with regulations governing requirements relating to compliance with the health i.e. safety requirements of the products of general use,
16) Monitoring shall mean systematic implementation of a series of planned activities in the public health system relating to measuring, taking samples for testing and monitoring of different parameters of the compliance with the health i.e. safety requirements over a specified time interval to gain insight into compliance with the health i.e. safety requirements and their possible harmful effect on human health, as well as insight into correct application of regulations in the field of products of general use,
17) Inspection sampling shall mean taking samples of the products of general use for the purpose of conducting laboratory tests where an inspector suspects lack of compliance with the health i.e. safety requirements of a product of general use, or where he cannot check compliance with the health i.e. safety requirements in some other manner,
18) Statement (claim) shall mean any message or representation on the label, including a pictorial, graphic or symbolic representation which claims, suggests or implies that a product of general use has particular properties,
19) Document of conformity shall mean the declaration of conformity, the test report, certificate, certificate of control or another document which confirms conformity of a product with the prescribed requirements,
20) Conformity marking shall mean the mark that the producer affixes on a product and which confirms that such product is in conformity with applicable requirements from all the regulations prescribing the affixing thereof,
21) Good manufacturing practice shall mean those aspects of quality assurance which ensure that materials and articles intended to come into contact with food and the products of general use are consistently produced and controlled to ensure conformity with the rules applicable to them, as well as with the quality standards appropriate for their intended use, neither endangering thereby human health nor causing unacceptable changes in the composition of the food and products of general use, i.e. not causing a deterioration in the organoleptic characteristics of food and products of general use,
22) Quality assurance system shall mean the total sum of the organized and documented procedures taken in order that the materials and items intended to come into contact with food and products of general use are of the quality required to achieve conformity with the rules applicable to them, as well as with the quality standards necessary for their intended use,
23) Quality control system shall mean the systematic application of measures (established within the quality assurance system) that ensure compliance of starting raw materials, semi-finished and finished materials and items intended to come in contact with food and products of general use with the specifications determined in the quality assurance system,
24) Food-contact side shall mean the surface of a material or article that is directly in contact with the food,
25) Non-food-contact side shall mean the surface of the material or article that is not directly in contact with food,
26) Approved laboratory shall mean the accredited laboratory which has been granted authorisation by the Ministry to conduct tests of compliance with the health i.e. safety requirements of the products of general use for the needs of official control,
27) Non-compliant product shall mean a product which is not compliant with the requirements of the regulations relating thereto,
28) Dangerous product shall mean a product which is not safe within the meaning of this Law,
29) Product presenting a risk shall mean a product that may have a harmful effect on human health to the extent exceeding what is considered reasonable and acceptable, under normal and reasonably foreseeable conditions of use of a given product,
30) Product presenting a serious risk shall mean a product presenting any risk requiring rapid intervention, including the cases where the consequences are not immediate,
31) Serious risk shall mean any risk, including the risks the consequences of which are not instantaneous i.e. immediate, requiring rapid intervention by the competent authorities, the seriousness of which is assessed in particular based on the possible consequences on health and safety of consumers and other users, as well as based on the frequency of such consequences.
Article 7
In order to achieve a high level of protection of human health and life, the measures to be applied, in compliance with this Law, shall be based on gathering of information, monitoring of the condition and assessment and analysis of the risk, except where this is not appropriate to the circumstances or the nature of the measure.
Sanitary monitoring of the products of general use shall be based on the principle of risk assessment and shall be proportionate to the estimated risk, so that the risk is effectively managed. Risk assessment shall be part of the risk analysis process, which shall include risk management and risk notification as well.
Risk assessment shall be determined by taking into account the available scientific evidence and specifically in an independent, objective and transparent manner.
Risk management shall be based on the results of risk assessment, the precautionary principle and other factors of relevance for the case under consideration.
Article 8
In case where, following an assessment of available information, the possibility of harmful effects on life and health is identified, but scientific data and information for objective risk assessment are lacking, provisional risk management measures necessary to ensure the high level of health protection in the Republic of Serbia may be adopted, which shall be applied until new scientific information required for a more objective risk assessment is available.
The measures referred to in paragraph 1 of this Article must be appropriate, no more restrictive of trade than is necessary to achieve the objective of this Law, as well as to take regard of the technical and economic feasibility of the measures and other factors of significance for the case under consideration.
The measures taken must be reviewed, within a reasonable period of time, depending on the nature of the risk to life or health identified, the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment.
3) Principle of Protection of Consumers’ Interests
Article 9
Consumers’ interests must be ensured to the highest level of protection.
The operators in the business of general use products shall provide information to the consumers enabling them to choose products in a manner which shall not be misleading to the consumers in respect of the product’s durability date, composition, characteristics, method of use and intended purpose of the product.
4) Principles of Transparency and Confidentiality
Article 10
Where, following an adequate analysis of the risk, there are reasonable grounds to suspect that the products of general use may have harmful effects on human health, the ministry in charge of the health-related matters (hereinafter referred to as: the Ministry) shall inform the public of the nature of the risk to health.
The notification referred to in paragraph 1 of this Article must include information on the product of general use, the category and the type of risk that it presents, as well as information on the measures and activities which are taken or about to be taken to prevent, reduce or eliminate that risk, by applying the requirements relating to transparency and confidentiality, in compliance with the regulations governing the field of general safety of products, observing the principle of confidentiality in order to protect a commercial secret or to preserve personal data.
Justification of the Measures
Article 11
Each measure taken under this Law in order to prohibit or restrict placing of a product of general use on the market, in order to withdraw a product of general use from the market or to recall it, must state the reasons on which such measure is based.
Such measures must be immediately notified to the party concerned, which shall be at the same time notified of the legal remedies available to them within the laws in force in the Republic of Serbia, as well as of the time limits applying to such remedies.
III SPECIAL WORKING GROUP ON CATEGORISATION OF BORDERLINE PRODUCTS
Categorisation of Borderline Products
Article 12
For individual products (hereinafter referred to as: the borderline products), it may be insufficiently clear, based on their appearance/presentation, composition, area of application, claims and other characteristics, whether they should be categorized as cosmetic products/products of general use within the meaning of this Law or whether they should fulfill the requirements from the regulations relating to other categories of products. The decision on categorisation of each individual borderline product shall be passed by the sanitary inspector based on the "case-by-case" principle, by taking into account all the characteristics of the product and by applying the recommendations i.e. the guides used in the European Union.
In case that in the course of a sanitary control, despite the application of the principle stated in paragraph 1 of this Article, a sanitary inspector is not able to perform the categorisation of the product, he may require the opinion of the Special Working Group of the Ministry for categorisation of the borderline products.
The opinion of the Special Working Group shall be binding. The Special Working Group shall provide the expert opinion within seven working days from the date of receipt of the request for expert opinion.
Special Working Group for Categorisation of Borderline Products
Article 13
With a view to considering the issues relating to demarcation and categorisation of the borderline products, the minister in charge of the health-related matters (hereinafter referred to as: the Minister), in compliance with the regulations governing public administration, shall, by means of a decision, establish and determine in more detail the method of operation of the Special Working Group for Categorisation of Borderline Products (hereinafter referred to as: the Special Working Group).
The administrative and technical tasks for the needs of the Special Working Group shall be performed by the Ministry.
The Special Working Group shall apply and use in their work the recommendations i.e. guides used in the European Union, by taking into account the definitions of the notions of these products which are part of the relevant legislation of the European Union and the national legislation of the Republic of Serbia.
Financing of the operation of the Special Working Group shall be laid down by a rulebook passed by the minister in charge of state administration with the consent from the minister in charge of finance affairs.
The Tasks of the Special Working Group
Article 14
Without prejudice to the rights, duties and powers of the sanitary inspector to decide, in each individual case, by taking into account the relevant expert opinions, whether a product shall be categorized as a product of general use or as a product governed by regulations relating to other categories of products, and with the aim of demarcating the said products, the Special Working Group shall perform the following tasks:
1) Prepare and draw up expert opinions, at the request of the Ministry relating to demarcation of individual groups of products of general use from the biocide products, medicinal products, medicines, etc.;
2) Notify the general public and the interested operator of the relevant information within the scope of work of the Special Working Group;
3) Collect, compare and analyze the scientific and technical data relating to demarcation of individual groups of products of general use from the biocide products, medicinal products, medicines, etc., as well as the case law of the European Court of Justice on the matters of borderline products;
4) Prepare and update the manual on borderline products;
5) Cooperate with the authorities of the EU Member States and candidate countries for membership in the European Union competent for demarcation of individual groups of products of general use from the biocide products, medicinal products, medicines, etc.;
6) Other tasks relating to demarcation of individual groups of products of general use from the biocide products, medicinal products, medicines, etc.
IV GENERAL CONDITIONS WHICH THE PRODUCTS OF GENERAL USE MUST FULFILL
Article 15
Only the products of general use complying with the health i.e. safety requirements i.e. the compliant products of general use, shall be allowed to be put on the market.
Article 16
The Minister shall regulate in more detail:
1) Materials and articles intended to come in contact with food, including the products intended for the babies and children under the age of tree for facilitation of feeding and sucking, pacification and sleeping, packaging for packing of food and products of general use,
2) Safety of toys,
3) Cosmetic products,
4) Materials and articles which, when used, come in direct contact with skin i.e. mucous membranes, irrespective of whether the integrity thereof is impaired or not,
5) Detergents, biocides and other agents for general use and maintenance of hygiene,
6) Tobacco, tobacco products, accessories for the use of tobacco products, electronic cigarettes and other systems for vapor inhalation systems with or without nicotine,
7) Health Certificate and Free Sale Certificate forms for the products of general use,
8) Requirements that the approved laboratories and reference laboratories for testing of products of general use must fulfill, as well as the area for which the reference laboratories need to be approved.
Products of General Use Which Are Non-Compliant with the Health i.e. Safety Requirements
Article 17
It shall be considered that a product of general use is not compliant with the health i.e. safety requirements if:
1) It lacks label i.e. if the same is not compliant with all the labeling requirements prescribed for the specific type of products of general use, in such a manner that it may endanger human health,
2) Changes have been brought about in its organoleptic characteristics due to physical, chemical, microbiological or other processes in a manner that may endanger human health,
3) When used, presents hazard for human health owing to its shape, manner of manufacture i.e. treatment,
4) Contains substances or ingredients which are not permitted, or it if it contains a quantity thereof which is not permitted, and which may have injurious effect on human health,
5) Contains a number of microorganisms exceeding the permitted one or other microorganisms which are harmful for human health,
6) In contact with food or other products of general use, contains or releases substances in quantities exceeding the prescribed ones, or substances that may have injurious effect on human health, or substances that may bring about changes in the organoleptic characteristics of the food or products of general use,
7) Contains radionuclides above the limits laid down by special regulations,
8) Is polluted with physical additions (mechanical impurities) which may be harmful to human health or cause nausea,
9) Due to its composition or other characteristics may have harmful effects on human health.
For specific products, presence of substances or ingredients referred to in paragraph 1, item 4) of this Article is additionally determined by means of the regulation governing restrictions and prohibitions on production, placing in circulation and use of chemicals.
Article 18
Without prejudice to the provisions of the regulations governing the field of advertising, it shall be prohibited to:
1) Attribute medicinal properties to a product of general use,
2) Label i.e. advertise a product of general use in a manner which is misleading for the consumers in respect of the actual composition, a characteristic or the intended purpose of these products.
Serbian, European and International Standards, Guidelines and Recommendations
Article 19
Without prejudice to the relevant legislation in the field of the products of general use, for the purpose of assessing compliance with the health and safety requirements, measures based on scientific principles, Serbian, European and international standards, guidelines and recommendations can be applied, to the extent necessary to protect human life and health and the environmental protection.
The measures aimed at ensuring compliance with the health and safety requirements of the products of general use shall be applied in such a manner as to avoid arbitrary and unjustified discrimination between countries in which the same or similar requirements prevail, in a manner that does not constitute a disguised barrier to the free movement of goods.
In order to ensure a higher level of protection of life and health than the level achieved by the measures based on the Serbian, European and international standards, guidelines and recommendations, other measures may also be taken with the aim of determining and ensuring compliance with the health i.e. safety requirements of the products of general use, where there is a scientific justification or where such measures would lead to a level of protection which is different to the one that the Republic of Serbia considers to be necessary.
V GENERAL OBLIGATIONS AND RESPONSIBILITIES OF OPERATORS IN THE BUSINESS OF PRODUCTS OF GENERAL USE
1. Obligations of Business Operators in Cases of Reasonable Doubt Concerning the Compliance With the Health i.e. Safety Requirements of the Products of General Use and Handling of the Products of General Use that Do not Comply with the Health i.e. Safety Requirements
Article 20
Without prejudice to the obligations of the business operators prescribed for each group of products of general use, their obligations shall additionally include:
1) Safe handling of the products of general use in cases of reasonable grounds to suspect compliance with the health i.e. safety requirements thereof,
2) Handling of the products of general use which are non-compliant with the health i.e. safety requirements.
Handling of the Products of General Use in Cases of Reasonable Grounds to Suspect the Compliance of the Products of General Use with Health i.e. Safety Requirements
Article 21
Based on a written notice of the Ministry or a sanitary inspector that there are reasonable grounds to suspect that a product of general use does not comply with the health i.e. safety requirements, the operator in business of products of general use shall take adequate actions in order to temporarily place such products out of circulation until proof of compliance with the health requirements is provided, and to notify the Ministry, i.e. the sanitary inspector and the general public thereof in writing, in compliance with the law.
Where the products of general use, for which there are reasonable grounds to suspect their compliance with the health i.e. safety requirements, have changed the owner, the operator in business of products of general use shall take adequate actions to withdraw such products from the operators which are holding them and to notify the Ministry and the general public thereof in writing.
Handling of the Products of General Use Which Do not Comply with the Health i.e. Safety Requirements
Article 22
Based on the written notice of the Ministry or a sanitary inspector on non-compliance of a product of general use with the health i.e. safety requirements, the operator in business of products of general use shall take adequate actions, which shall be proportionate to the risk involved, and to notify the Ministry i.e. the sanitary inspector and the general public thereof in writing, in compliance with the law.
Where the products of general use, which have been found to be non-compliant with the health i.e. safety requirements, have reached the consumers, the operator in business of products of general use shall inform the consumers in an efficient and clear manner of the reason for recall of the product of general use and, where necessary, to request that the consumers return the product of general use which have already been supplied to them, where the high level of protection of health cannot be achieved by means of other measures, and to notify the Ministry and the general public thereof in writing.
The costs of withdrawing/recall shall be borne by the operator in business of products of general use responsible for the non-compliance with the health i.e. safety requirements of the product of general use.
Destroying of the products of general use which are non-compliant with the health i.e. safety requirements shall be carried out in a manner that is safe and not harmful for human health and the environment in compliance with the regulations governing the field of waste management.
The operator in business of products of general use shall notify the sanitary inspector in writing of the place, date and of the destroyed quantity of the products of general use which are non-compliant with the health and safety requirements and to provide proof that these have been destroyed in accordance with paragraph 4 of this Article.
The costs of destruction shall be borne by the operator in business of products of general use responsible for the non-compliance of the product of general use with the health i.e. safety requirements.
2. Obligations and Responsibilities of the Producers of Products of General Use with Headquarters in the Republic of Serbia
Article 23
Without prejudice to the obligations of the producers prescribed for individual groups of products of general use, their obligations shall additionally include:
1) Setting up and implementation of internal control,
2) Ensuring compliance with the sanitary and technical and hygienic requirements,
3) Provision of dedicated means of transport,
4) Taking of hygienic measures in compliance with good manufacturing practice, good hygienic practice and other applicable standards,
5) The scope and frequency of laboratory testing and possession of the prescribed proof of compliance with the health i.e. safety requirements for the products.
1) Internal Control
Article 24
Internal control shall imply the obligation of the producer to conduct control of:
1) Keeping of documentation on supply and compliance of the raw materials and packaging,
2) Implementation of the system of control of the production conditions with respect to the premises, equipment, tools, workers and transport during production,
3) Implementation of the system of control in the production process and of the finished product.
Manufacturers of the products of general use shall, in a documented manner, in compliance with their respective business activities, put in place and conduct internal control in all stages of production and circulation, in compliance with the principles of good manufacturing practice, good hygienic practice, manuals, as well as analyses of hazards and control of critical spots, in compliance with the implemented quality system standards.
The manufacturers’ obligations referred to in items 2) - 5) of Article 23 shall be regulated in more detail by the law regulating sanitary supervision.
VI SYSTEM OF RAPID INFORMATION AND ALERTING, CONDITIONS AND METHOD OF INFORMING AND EXCHANGE OF INFORMATION
Article 25
The prescribed systems of rapid information and alert established by the laws regulating food safety and general product safety, such as the network for communication of direct and indirect risks the source of which are products of general use shall be used for communication, exchange of information on non-compliance with the health i.e. safety requirements of the products of general use, as well as for notification of measures taken in order to prevent or eliminate risks for human health caused by the use of the said products.
Other Ministries, health services, authorized and accredited laboratories, operators in business of products of general use shall also take part in the system of rapid information and alert in compliance with this Law and other regulations.
The law regulating the field of food safety and general product safety and other regulations governing the method of establishing and operation of the system for rapid exchange of information on dangerous products, including dangerous products of general use referred to in Article 4 of this Law shall apply mutatis mutandis in respect of the conditions and method of informing and exchange of information and data with other authorities, organizations, regulatory bodies and institutions taking part in the assessment and management of risk in the Republic of Serbia and organizations in foreign countries.
The Minister shall designate the persons for contact and exchange of information with the competent authority within the system of rapid information and alert, i.e. within the system of rapid exchange of information on dangerous products.
Article 26
Information available to the participants in the system of rapid information and alert relating to the risk for health the source of which are products of general use must be made available to the general public in compliance with this Law and other regulations.
Information on products of general use, the nature of the risk and on the measure taken must be available to the general public in compliance with the law.
Article 27
All the participants in the system of rapid information and alert shall, within their respective scopes of competences, immediately notify the Ministry of the emergence of serious risk for human health.
When the products of general use may constitute a serious risk to human health or to the environment, and where such risk may not be satisfactorily eliminated, the Minister shall order that the emergency measures be taken in compliance with this Law and regulations governing food safety and general product safety.
Where the products of general use are of domestic origin, the following emergency measures shall be taken:
1) Temporary ban on production and placing on the market or use of the product of general use,
2) Determining of special conditions for handling of the products of general use which are non-compliant with the health requirements i.e. unsafe (that pose risk),
3) And other relevant activities, proportionately to risk assessment.
Where the products of general use are imported, the following emergency measures shall be taken:
1) Temporary ban on import of suspect products of general use from the country or a part of the country of export i.e. country of production,
2) Temporary ban on placing on the market or use of the products of general use,
3) Determining special requirements for handling the said products of general use from the country or from a part of the country of export i.e. country of production.
The emergency measures shall be in force until the high risk for human health ceases to exist.
The Minister shall inform the general public of the termination of emergency measures.
GROUPS OF PRODUCTS OF GENERAL USE
VII MATERIALS AND ARTICLES INTENDED TO COME INTO CONTACT WITH FOOD
1) General Requirements for Materials and Articles Intended to Come into Contact with Food
Article 28
Materials intended to come into contact with food are the substances and materials used to manufacture the products of general use that come into contact with food.
Products intended to come into contact with food are the dishes, cutlery, equipment, devices, plants and packaging used for packing food and products of general use.
General Requirements for Materials and Articles Intended to Come into Contact with Food
Article 29
Materials and articles, including active and intelligent materials and articles intended to come into contact with food, shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could:
1) Endanger human health,
2) Bring about an unacceptable change in the composition of food,
3) Bring about deterioration in the organoleptic characteristics of food.
The labeling, advertising and presentation of a material or article intended to come into contact with food must not mislead the consumer.
Article 30
Materials and articles intended to come into contact with food must be labeled in Serbian language, in compliance with this Law and the secondary legislation regulating the field of materials and articles intended to come into contact with food.
Article 31
Special measures, which are prescribed by secondary legislation that regulates the field of materials and articles intended to come into contact with food, require that the materials and articles, which are covered by these measures, are accompanied with a written declaration stating that the materials and articles comply with the rules applicable to them.
The written declaration (hereinafter referred to as: the declaration of conformity) referred to in paragraph 1 of this Article shall be issued by the business operator and it shall include information prescribed by the secondary legislation regulating the field of materials and articles intended to come into contact with food.
Appropriate documentation must be available to prove such compliance.
The above mentioned documentation must be made available for inspection to the sanitary inspector on demand.
Article 32
The traceability of materials and articles must be ensured at all stages in order to: facilitate control, recall of defective products, consumer information and establishment of responsibility.
With due regard to technological feasibility, business operators must have in place systems and procedures which are allowing identification of the business operators that supply or from whom are supplied the materials or articles and, where appropriate, substances or products covered by this legislation and its implementing measures used in their manufacture. Such information must be made available to the Ministry on demand.
The materials and articles which are placed in circulation shall be identifiable by an appropriate system which allows their traceability by means of labeling or relevant documentation or information.
The business operator must possess adequate documentation whereby it shall prove that the materials and articles, products from the intermediary stages of the production thereof and substances envisaged for production of such materials and articles are in compliance with the requirements of this Law and the secondary legislation regulating this field.
The documentation referred to in paragraph 4 of this Article shall include the test conditions and results, calculations, including modeling, other analyses and proof of compliance with the health i.e. safety requirements or an explanation evidencing conformity.
The business operator that uses recycled plastic in production of materials and articles intended to come into contact with food must also possess relevant declaration of conformity which shall, among other things, comprise an additional piece of information that only the recycled plastic obtained in an approved recycling procedure is used in manufacturing thereof, stating also the number of the approval, as well as other data on conformity of the material with this Law and the secondary legislation that governs the field of materials and articles intended to come into contact with food.
2) Good Manufacturing Practice for Materials and Articles Intended to Come into Contact with Food
Article 33
The rules on good manufacturing practice shall apply to the groups of materials and articles intended to come into contact with food, to their combination, as well as to the recycled materials and articles used in manufacturing of materials and articles intended to come into contact with food.
Article 34
The rules on good manufacturing practice must be applied in all stages of manufacture, processing and distribution of materials and articles intended to come into contact with food, excluding the production of starting raw materials for production of materials and articles intended to come into contact with food.
The rules on good manufacturing practice shall, on a need to basis, apply to procedures involving the application of printing inks, to the use of recycled plastics and material applied to the surface that does not come in contact with food in the production of materials and articles intended to come into contact with food, in compliance with the secondary legislation regulating the field of materials and articles intended to come into contact with food.
Conformity with the Good Manufacturing Practice
Article 35
The business operator shall ensure that the manufacturing operations are conducted in compliance with:
1) The general rules on good manufacturing practice defined by the quality assurance system, quality control system and appropriate establishing and maintenance of relevant documentation,
2) The rules on good manufacturing practice prescribed by secondary legislation that governs the field of materials and articles intended to come into contact with food in the part relating to the use of printing inks, recycled materials or other materials.
Article 36
The business operator shall establish, apply and maintain an effective and documented quality assurance system. This system must:
1) Take account of the personnel capabilities, their knowledge and skills, and the organization of premises and equipment which are necessary to ensure that finished articles and materials comply with the rules applicable to them,
2) Be applied in conformity with the size of the business run by the operator, so as not to overburden it.
Starting raw materials shall be selected based on the pre-established specifications that shall ensure compliance of materials and articles intended to come into contact with food with the rules applicable to them.
Substances used in making plastic layers in plastic materials and articles must be of the technical quality and purity suitable for the intended and foreseeable use of such materials or articles.
The composition must be known to the producer of the substance and made available to the competent authority on demand.
Different manufacturing processes shall be carried out in compliance with the pre-established instructions and procedures.
Article 37
The business operator shall establish and maintain an efficient quality control system.
The quality control system shall include monitoring of the implementation and achievement of the objectives of good manufacturing practice and identify corrective measures if such objectives are not achieved. Such corrective measures shall be implemented without delay and made available to the sanitary inspector for inspection.
Article 38
The business operator shall prepare and store appropriate documentation in paper or electronic format that relates to specifications, manufacturing formulae and processing which are relevant to compliance and safety of the finished material or article.
The business operator shall prepare and store appropriate documentation in paper or electronic format, which shall include the records covering various manufacturing operations performed which are relevant to compliance with the prescribed requirements and safety of the finished material or article, complying with the results of the quality control.
The documentation shall be made available by the business operator to the sanitary inspectors upon request.
The Notion of Toys
Article 39
Toys are products designed or intended, exclusively or not, for use in play by children under 14 years of age.
1. Obligations of Business Operators
Obligations of the Manufacturer
Article 40
When placing the toys on the market, manufacturers must ensure that the toys have been designed and manufactured in accordance with the essential safety requirements and particular safety requirements set out in this Law and the secondary legislation governing the field of toy safety.
Manufacturers shall draw up the required technical documentation in the manner prescribed by secondary legislation regulating the field of toy safety and carry out the prescribed conformity assessment procedure in accordance with this Law. In cases where compliance of a toy with the prescribed requirements has been demonstrated by that procedure, manufacturers shall draw up a declaration of conformity, and affix the marking of conformity, as set out in this Law.
Manufacturers shall keep the technical documentation and the declaration of conformity for a period of ten years after the toy has been placed on the market of the Republic of Serbia.
Manufacturers shall ensure application of procedures that ensure that the toys remain in conformity in case of serial production. Changes in toy design or its characteristics or changes in the applied standards or other technical specifications by reference to which conformity of a toy is declared shall be taken into account in adequate manner . When deemed necessary with regard to toys that present a risk, manufacturers shall, to protect the health and safety of consumers, carry out sample testing of toys put on the market, investigate, and, if necessary, keep a register of complaints and register of non-conforming toys and returned toys, and shall keep distributors informed of any such monitoring.
Manufacturers shall ensure that their toys bear a type, batch, serial or model number or other element allowing their identification, or, where the size or nature of the toy does not allow it, that the required information is provided on the packaging (or in a document accompanying the toy).
Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the toy or, where that is not possible, on its packaging or in a document accompanying the toy. The address shall indicate a single point at which the manufacturer can be contacted. Manufacturers should enclose with the toy the instructions and safety information in Serbian language.
Manufacturers who consider or have reason to believe that a toy which they have placed on the market is not in conformity with the provisions of this Law and of the secondary legislation regulating the field of toy safety shall immediately take the measures necessary to bring that toy into conformity, to withdraw it from the market or recall it, if necessary. Where the toy presents a risk, the manufacturer shall immediately inform the Ministry thereof, giving details, in particular of the non-compliance of the toy and of the measures taken.
Based on the request from the Ministry, the manufacturers shall enclose complete information and documentation necessary to demonstrate the conformity of the toy in question, in Serbian language. At the request of the Ministry, the manufacturer shall cooperate with the Ministry as regards any action taken to eliminate the risks posed by a toy it has placed on the market.
Article 41
A manufacturer may appoint an authorized representative.
The authorized representative may not perform the tasks of the manufacturer referred to in Article 40, paragraph 1 of this Law or the tasks comprising the preparation of technical documentation referred to in Article 40, paragraph 2 of this Law, since these tasks are not part of the authorized representative’s mandate.
An authorized representative shall perform the tasks specified in the mandate received from the manufacturer. Such mandate shall allow the authorized representative to perform the following tasks:
1) To keep the declaration of conformity for a period of ten years after the toy has been placed on the market and to, at the request of the sanitary inspection, provide for inspection the declaration of conformity and access to technical documentation,
2) Further to a request from the Ministry, to provide complete information and documentations necessary to demonstrate the conformity of the toy in question,
3) At the request of the Ministry, to cooperate on all the actions taken with the aim of eliminating the risks posed by toys covered by the mandate.
Article 42
Importers shall place on the market of the Republic of Serbia only the toys which are compliant with this Law and the secondary legislation passed in implementation of this Law.
Prior to placing a toy on the market, importers shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturers. Importers shall ensure that the manufacturers have drawn up the technical documentation, that the toy has been marked with the prescribed conformity marking and that it is accompanied by the required documentation, and that the manufacturer has complied with the requirements referred to in Article 40, paragraphs 5 and 6 of this Law. Where an importer considers or has reason to believe that a toy is not in conformity with the essential safety requirements and with the specific safety requirements prescribed by this Law and the secondary legislation regulating the field of toy safety, the importer shall place the toy on the market only after the toy has been brought into conformity with the prescribed requirements. Where the toy presents a risk, the importer shall inform the manufacturer and the sanitary inspection to that effect.
Importer shall indicate its name, registered trade name or registered trade mark and the address at which it can be contacted on the toy or, where that is not possible, on its packaging or in a document accompanying the toy.
Importer shall enclose the toy with instructions and safety information in Serbian language.
Importer shall ensure that, while a toy is under its responsibility, storage or transport conditions do not jeopardize the compliance of such toy with the essential safety requirements and particular safety requirements prescribed by this Law and the secondary legislation regulating the field of toy safety.
When deemed appropriate with regard to the risks presented by a toy, importer shall, to protect the health and safety of consumers, carry out sample testing of toys put on the market, investigate, and, where necessary, keep a register of complaints and of non-conforming toys and toy recalls, and shall keep distributors informed of all that.
Importer who considers or has reason to believe that a toy which it has placed on the market is not in conformity with the provisions of this Law and the secondary legislation regulating the field of toy safety shall immediately take the corrective actions necessary to bring that toy into conformity, to withdraw it from the market or recall it, if necessary. Where the toy presents a risk, the importer shall immediately inform the Ministry to that effect, giving details, in particular, of the non-compliance and of all the corrective actions taken.
Importer shall, for a period of ten years after the toy has been placed on the market, keep the declaration of conformity and at the request of the sanitary inspection, make available for inspection the declaration of conformity and provide access to technical documentation.
Importer shall, further to a request from the Ministry, provide the Ministry with complete information and documentation necessary to demonstrate the conformity of the toy in question in Serbian language. The importer shall cooperate with the Ministry, at its request, on all the actions taken to eliminate the risks posed by toys which they have placed on the market.
Article 43
When delivering a toy on the market, the distributor shall act with due care in relation to the prescribed requirements.
Prior to delivery of a toy on the market, the distributor shall verify that the toy has been marked with the required conformity marking, that it is accompanied by the required documentation, instructions and safety information in Serbian language, as well as that the manufacturer and the importer have complied with the requirements set out in Article 40, paragraphs 5 and 6 of this Law and in Article 42, paragraph 3 of this Law. Where a distributor considers or has reason to believe that a toy is not in conformity with the essential safety requirements and with the particular safety requirements prescribed by this Law and the secondary legislation regulating the field of toy safety, the distributor shall deliver the toy on the market only after the toy has been brought into conformity with the prescribed requirements. Where the toy presents a risk, the distributor shall inform the manufacturer or the importer, as well as the sanitary inspection, to that effect.
The distributor shall ensure that, while a toy is under their responsibility, storage or transport conditions do not jeopardize the compliance of the toy with the essential safety requirements and with the particular safety requirements prescribed by this Law and the secondary legislation regulating the field of toy safety.
Distributor who considers or has reason to believe that a toy which they has delivered to the market is not in conformity with the provisions of this Law and of the secondary legislation regulating the field of toy safety shall immediately take the corrective actions necessary to bring that toy into conformity, to withdraw it from the market or recall it, where necessary. Where the toy presents a risk, the distributor shall immediately inform the Ministry, giving details, in particular, of the non-compliance and of all the corrective actions taken.
Upon request, the distributor shall provide the Ministry with complete information and documentation necessary to demonstrate the conformity of the toy in question. The distributor shall cooperate with the Ministry upon its request, as regards any action whose goal is to eliminate the risks posed by the toy it delivered to the market.
Cases in Which Obligations of Manufacturers Apply to Importers and Distributors
Article 44
An importer or distributor shall be considered a manufacturer, within the meaning of this Law, and shall be subject to the obligations of the manufacturer, in compliance with Article 40 of this Law, where it places a toy on the market under the distributor’s name or trademark, or modifies a toy already placed on the market in such a way that compliance with the prescribed requirements is affected.
Identification of Business Operators
Article 45
Business operators shall, at the request of the sanitary inspection, provide the following pieces of information:
1) Information on any business operator who has supplied them with a toy,
2) Information on any business operator to whom they have supplied a toy.
Business operators must be able to present the information referred to in paragraph 1 of this Article:
1) In the case of the manufacturer - over a period of 10 years after the toy has been placed on the market,
2) In the case of other business operators - over a period of ten years after they have been supplied with the toy.
Article 46
Toys may not be placed on the market of the Republic of Serbia unless they comply with the essential safety requirements defined as:
1) The general safety requirements,
2) The particular safety requirements.
The essential safety requirements shall be prescribed in more detail by the secondary legislation regulating the field of toy safety.
Toys placed on the market must comply with the essential safety requirements during their foreseeable and normal period of use.
Article 47
Manufacturer shall mark the warnings on the toy in compliance with the secondary legislation regulating the field of toy safety.
In compliance with Article 40, paragraph 6 of this Law, the warnings and safety instructions must be made in Serbian language.
Article 48
Prohibition of delivery of toys on the market of the Republic of Serbia which comply with the provisions of this Law and the secondary legislation regulating the field of toy safety shall not be allowed.
Article 49
It shall be presumed that a toy is in conformity with the essential safety requirements and with the particular safety requirements prescribed by this Law and the secondary legislation regulating the field of toy safety if the same is in conformity with the Serbian standards transposing the relevant harmonized standards the list of which (hereinafter referred to as: the List of Standards) shall be drawn up and published in compliance with the law regulating technical requirements for products and conformity assessment. The List of Standards for conformity of toys shall be published enclosed with the secondary legislation regulating the field of toy safety.
Article 50
The Declaration of Conformity shall confirm fulfillment of the requirements set out in the essential safety requirements and in particular safety requirements, which are prescribed by this Law and the secondary legislation regulating the field of toy safety.
Elements of the Declaration of Conformity shall be prescribed in more detail by the secondary legislation regulating the field of toy safety.
By drawing up and issuing the Declaration of Conformity, the manufacturer shall assume responsibility for the compliance of the toy in question.
The procedure of issuing and revocation of the Declaration of Conformity shall be conducted in compliance with the law regulating general administrative procedure.
General Principles of the Marking of Conformity
Article 51
Toys delivered to the market of the Republic of Serbia must bear the Serbian marking of conformity in compliance with the law regulating the field of technical requirements for products and conformity assessment.
Marking of conformity shall be affixed by the manufacturer or his representative i.e. the importer where the manufacturer is not registered in the territory of the Republic of Serbia.
Marking of conformity shall be subject to the general principles from the laws regulating the field of technical requirements for products and conformity assessment.
The toys which do not bear the marking of conformity or which do not otherwise comply with this Law and the secondary legislation regulating the field of toy safety may be exhibited and used at trade fairs and exhibitions, providing that they are accompanied by a sign which clearly indicates that such toys do not comply with this Law and the secondary legislation regulating the field of toy safety and that they will not be delivered to the market of the Republic of Serbia before their conformity with the requirements from this Law and the secondary legislation regulating the field of toy safety is provided.
Rules and Conditions for Affixing the Marking of Conformity
Article 52
Marking of conformity shall be affixed on to the toy before the toy is placed on the market of the Republic of Serbia, in compliance with the secondary legislation regulating the field of toy safety.
Article 53
The manufacturer shall, prior to placing a toy on the market, carry out an analysis of the hazards that the toys may present in terms of chemical, physical, mechanical, electrical hazards, and hazards in relation to flammability, hygiene and radioactivity, as well as to carry out an assessment of the potential exposure to such hazards.
Conformity Assessment Procedures
Article 54
In order to demonstrate conformity of the toy with the essential safety requirements and with the particular safety requirements prescribed by this Law and the secondary legislation regulating the field of toy safety, prior to placing of the toy on the market, the manufacturers shall use the following conformity assessment procedures:
1) Internal control of production ,
2) Type examination.
The internal control of production shall be applied in cases where the manufacturer has applied the Serbian standards from the List of Standards covering all relevant safety requirements for the toy.
The examination of the type referred to in Article 55 and conformity with the type based on internal control of production shall be applied in the following cases:
1) Where the Serbian standards from the List of Standards covering all the relevant safety requirements for the toy do not exist,
2) Where the Serbian standards referred to in item 1) exist, but the manufacturer has not applied them or has applied them only in part,
3) Where one or more of the Serbian standards referred to in item 1) has been published with a restriction,
4) Where the manufacturer considers that the nature, design, construction or purpose of the toy necessitates a third party verification process conducted by the appointed conformity assessment body.
The conformity assessment procedure shall be carried out in compliance with the law regulating general administrative procedure.
Article 55
An application for type examination, performance of that examination and issue of the certificate of type examination shall be carried out in accordance with the law regulating the field of technical requirements for products and conformity assessment.
The application for type examination shall include a description of the toy and an indication of the place of manufacture, including the address.
In the procedure of carrying out the type examination, the appointed conformity assessment body shall evaluate the analysis of the hazards that the toy may present which has been previously carried out by the manufacturer in compliance with Article 53 of this Law. Where necessary, the appointed body shall carry out the evaluation of the analysis of the hazards together with the manufacturer.
The certificate of type examination shall include a reference to this Law, a color image and a clear description of the toy in question, including its dimensions, and a list of the tests performed, together with a reference to the relevant test report. The certificate of type examination shall be reviewed every five years and, where necessary more frequently, in particular in case of a change to the manufacturing process, the raw materials or the components of the toy. The certificate of type examination shall be withdrawn if the toy fails to comply with the essential safety requirements and with the particular safety requirements prescribed by this Law and the secondary legislation regulating the field of toy safety. The appointed body shall not grant a certificate of type examination for a toy in respect of which certificates have been refused or withdrawn. The procedures of issuing and withdrawal of the certificate of type examination shall be carried out in compliance with the law regulating the general administrative procedure.
The technical documentation and correspondence relating to the type examination procedures shall be drawn up in the official language of the country in which the reported body has been established or in a language acceptable to that body.
Article 56
At the request of the sanitary inspection, the manufacturer, the authorized representative or the importer shall provide technical documentation. In case that the technical documentation is not drawn up in Serbian language, the authorized representative or the importer shall provide translation of the relevant parts of the technical documentation into Serbian language. When a sanitary inspector requests from the manufacturer i.e. representative or importer the technical documentation or translation of the parts thereof, he may set a time limit of 30 days for receipt of such a document or translation, except where a shorter time limit is duly justified in the case of serious and immediate risk.
If the manufacturer i.e. the representative or importer does not comply with the requirements of this Law and the secondary legislation regulating the field of toy safety in respect of the technical documentation, the sanitary inspector may require an approval to have a conformity test performed by the appointed body in compliance with the law, within a specified time limit, in order to verify compliance with the requirements of this Law, at the expense of the manufacturer i.e. representative or importer.
Article 57
The conformity assessment body established in the Republic of Serbia must be accredited by the Accreditation Body of the Republic of Serbia in compliance with the law and appointed by the Minister to perform certain conformity assessment tasks.
The conformity assessment body must comply with the basic requirements relating to the tasks within the scope of accreditation which is an integral part of the accreditation document referred to in paragraph 1 of this Article, in particular in respect of:
1) The professional qualifications of the employees and other persons hired,
2) Premises and equipment,
3) Independence and impartiality vis-à-vis the persons involved with the toy which is subject to conformity assessment,
4) Handling the objections to their work and decisions passed,
5) Professional secrecy,
6) Liability insurance.
The decision on appointment of a conformity assessment body shall be passed by the Minister in compliance with the law regulating general administrative procedure.
Where the appointed body no longer fulfills the requirements referred to in paragraphs 1 and 2 of this Article or does not discharge its obligations in compliance with the law, the Minister shall pass a decision on revocation of the decision referred to in paragraph 3 of this Article in compliance with the law regulating general administrative procedure.
Before passing of the decision referred to in paragraph 4 of this Article, the Minister may, taking into account the type of the deficiency in respect of the compliance with the basic requirements or discharging of obligations, warn the appointed body thereof in writing and set a time limit for it to remove the deficiencies, which may not be longer than 60 days.
The decision referred to in paragraph 4 of this Article shall be final in an administrative procedure and an administrative dispute may be initiated against it.
If the Minister passes the decision referred to in paragraph 4 of this Article or if the appointed body ceases its operations, the Minister may order it to, within a specified time limit, complete the transfer of documentation relating to conformity assessment to another appointed body of the manufacturer’s choice, i.e. to provide availability of such documentation to the competent authorities.
The register of appointed bodies shall be maintained by the ministry in charge of the economy in compliance with the law.
Article 58
The appointed body and the manufacturer i.e. authorized representative of the manufacturer shall, by mutual consent, set the time limits for carrying out of the conformity assessment procedure and verification of conformity prescribed by this Law and the adopted implementing secondary legislations thereto, which are related to type examination, verification, manufacturing quality assurance and toy quality assurance.
The appointed body shall notify the Ministry of any issued, amended, supplemented, suspended and withdrawn certificate, as well as of the certificates the issue of which has been refused.
The appointed body shall also notify other conformity assessment bodies appointed in compliance with this Law of the certificates which have been suspended, withdrawn or the issue of which has been refused, as well as of the certificates issued to the manufacturer i.e. to the authorized representative of the manufacturer, upon request.
The appointed body shall also provide other relevant pieces of information upon request referred to in paragraphs 2 and 3 of this Article.
Where the appointed body finds that the essential requirements have not been met or that they are no longer met by a manufacturer, or that the certificate should not have been issued in relation to the type and scope of the non-conformity, the appointed body shall suspend, withdraw or restrict the certificate issued, unless where the manufacturer, by applying adequate corrective measures, ensures conformity with the essential requirements. In case of a suspension, withdrawal i.e. restricting of a certificate, the appointed body shall inform the Ministry thereof.
At the request of the Ministry, the appointed body shall provide relevant information and documentation, including the financial documentation needed for the Ministry to verify compliance with the essential requirements relating to marking by the Serbian mark of conformity.
The appointed body may, in duly justified cases, request that the manufacturer i.e. the authorized representative of the manufacturer, provide complete information and data required for establishing and maintaining the confirmed conformity in respect of the selected conformity assessment procedure.
Article 59
The Ministry shall monitor the work of the appointed body.
5. Toys Presenting a Risk and Formal Non-Compliance
Dealing with the Toys Presenting a Risk
Article 60
Where the sanitary inspection has taken measures in compliance with the regulations governing the field of market supervision in respect of product placing on the market or where it has sufficient reason to believe that a toy, to which provisions of this Law and of the secondary legislation regulating the field of toy safely apply, presents a risk to the health or safety of persons, it shall carry out an evaluation whether the toy concerned fulfills all the requirements laid down by this Law and the secondary legislation governing the field of toy safety. The toy business operators shall cooperate with the sanitary inspection. Where, in the course of that evaluation, the sanitary inspection finds that the toy concerned does not fulfill the requirements laid down in this Law and the secondary legislation governing the field of toy safety, it shall demand from the relevant toy business operator to, without delay, take appropriate corrective action to bring the toy into compliance with those requirements, to withdraw the toy from the market, or to recall it within a reasonable period, which must be commensurate with the nature of the risk, depending on what the sanitary inspection prescribes. The sanitary inspection shall accordingly inform the appointed body that has issued the Declaration of Conformity for the product in question i.e. where applicable, the appointed body that has recognized a foreign Declaration of Conformity.
Regulations governing the field of market supervision shall apply to the measures taken by the business operators.
The toy business operator shall ensure that appropriate corrective actions are taken in respect of toys which it has made available on the market of the Republic of Serbia.
Where the relevant toy business operator does not take adequate corrective action within a reasonable period, the sanitary inspection shall take appropriate provisional measures to prohibit or restrict the availability of the toy in question on the market of the Republic of Serbia, to withdraw the toy from the market or to ensure its recall.
Article 61
Without prejudice to the provisions of this Law prescribing handling of the toys which present a risk, the sanitary inspection shall request from the business operator to remove the non-compliance in question, where they find that:
1) The conformity marking has not been affixed in accordance with Articles 51 and 52 of this Law and the secondary legislation regulating the field of toy safety,
2) The conformity marking has not been affixed to the product,
3) The declaration of conformity has not been drawn up,
4) The declaration of conformity has not been drawn up properly,
5) Technical documentation is either not available or not complete.
Where the non-compliance referred to in paragraph 1 of this Article persists, the sanitary inspection shall take appropriate measures to restrict or prohibit the toy’s availability on the market, or shall ensure that the toy is recalled or withdrawn from the market.
1. The Notion of a Cosmetic Product
Article 62
Cosmetic products are substances or mixtures intended to come into contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance i.e. correcting body odors, i.e. protecting them and keeping them in good condition.
A substance or mixture intended to be ingested, inhaled, injected or implanted into the human body shall not be considered to be a cosmetic product.
2. Safety, Responsibility and Free Movement
Article 63
Cosmetic products made available on the market must be safe for human health when used under normal or reasonably foreseeable conditions of use, taking account, in particular, of the following:
1) Appearance of the product including conformity with regulations governing misleading products within the meaning of the general product safety,
2) Its labeling,
3) Instructions for use and disposal,
4) Any other indication or information provided by the responsible person defined in Article 64 of this Law.
The provision of warnings shall not exempt the responsible person from the obligation to comply with the other requirements laid down in this Law and the secondary legislation regulating the field of cosmetic products.
Article 64
Only cosmetic products for which a legal or natural person is designated in the Republic of Serbia as the responsible person may be placed on the market.
The responsible person referred to in paragraph 1 of this Article shall ensure compliance with the obligations set out by this Law for each cosmetic product placed on the market.
For a cosmetic product manufactured in the Republic of Serbia, and not subsequently exported and imported back into the Republic of Serbia, the manufacturer whose headquarters are in the Republic of Serbia shall be considered to be the responsible person.
The manufacturer referred to in paragraph 1 of this Article may designate, by written mandate, a person established in the Republic of Serbia as the responsible person.
For a cosmetic product manufactured in the Republic of Serbia, and not subsequently exported and imported back into the Republic of Serbia, the manufacturer whose headquarters are located outside the Republic of Serbia shall designate, by written mandate, a person established within the Republic of Serbia as the responsible person.
For an imported cosmetic product, each importer shall be considered to be the responsible person for the specific cosmetic product that it places on the market.
The importer may, by written mandate, designate a person established within the Republic of Serbia as the responsible person.
The distributor shall be considered to be the responsible person where he places a cosmetic product on the market under his name or trademark, or where he modifies a product already placed on the market in such a way that compliance with the requirements applicable thereto may be affected.
By way of exception to paragraph 8 of this Article, the translation of information on the cosmetic product that has already been placed on the market shall not be considered as a product modification that may affect the compliance with the requirements of this Law.
Obligations of Responsible Persons
Article 65
Responsible persons shall ensure compliance with the provisions of this Law and of the secondary legislation regulating the field of cosmetic products, which are relating to the safety of a cosmetic product, principles of good manufacturing practice, assessment of safety, dossier with product information, sampling and analysis, restrictions for individual substances, in compliance with the secondary legislation regulating the field of cosmetic products, substances classified as carcinogenic, mutagenic and substances toxic for reproduction, traces of prohibited substances, animal testing, information available to the general public, claims, reporting of serious undesirable effects, information on substances, as provisions on a label.
Responsible persons who consider or have reason to believe that a cosmetic product which they have placed on the market is not in conformity with this Law must immediately take the corrective measures necessary to ensure that such product is brought into conformity, to withdraw it or to recall from the end user it, as appropriate.
Furthermore, where the cosmetic product presents a risk to human health, responsible persons must immediately inform the competent state authorities of the EU Member States in which they made the product available as well as of the EU Member State in which the Product Information File is easily accessible, giving details, in particular, of the non-compliance and of the corrective measures taken.
Responsible persons shall cooperate with the Ministry, at the request of the Ministry, on any action to eliminate the risks posed by cosmetic products which they have made available on the market. In particular, responsible persons shall, further to a request from the Ministry, provide it with all information and documentation necessary to prove conformity of specific aspects of the product, in Serbian language i.e. in a language which can be easily understood by the competent authority.
Article 66
In the context of their activities, when making a cosmetic product available on the market, distributors shall act with due care in relation to applicable requirements of this Law and of the secondary legislation regulating the field of cosmetic products, which the cosmetic product must fulfill.
Prior to making a cosmetic product available on the market, distributors shall verify:
1) Whether the product is marked with prescribed information in respect of the name and address of the responsible person, country of production (for the imported products), number of the production batch and the list of ingredients,
2) Whether, in the case of a soap, bath balls and other small products where it is impossible (due to the size and shape thereof) for practical reasons for the information on ingredients to appear in an enclosed leaflet, on a label, tape or a card, such information appears in immediate proximity to the container in which the cosmetic product is exposed for sale,
3) Whether, for the cosmetic products that are not pre-packaged, but are packaged at the point of sale at the purchaser's request, the declaration is indicated on the wrapping in which the product is placed for sale, or in the point of sale (if the product is not kept in a separate wrapping),
4) Whether the requirements in respect of the language are fulfilled in compliance with the law,
5) Whether the date of indicated minimum durability has expired, where applicable in compliance with the secondary legislation regulating the field of cosmetic products.
Where distributors consider or have reason to believe that:
1) A cosmetic product is not in conformity with the requirements laid down in this Law, they must not make the product available on the market until its conformity with the applicable requirements of this Law and of the secondary legislation regulating the field of cosmetic products is ensured,
2) A cosmetic product which they have delivered to the market is not in conformity with this Law, they must make sure that the corrective measures necessary to bring that product into conformity, to withdraw it or recall it from the end user, as appropriate, are taken.
Furthermore, where the cosmetic product presents a risk to human health, distributors must immediately inform the responsible person referred to in Article 64 of this Law and the Ministry, giving details, in particular, of the non-compliance and of the corrective measures taken.
Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardize its compliance with the requirements set out in this Law.
Distributors shall cooperate with the Ministry, at the request of the Ministry, on any action to eliminate the risks posed by the products which they have made available on the market. In particular, distributors must, further to a request from the Ministry, provide the Ministry with complete information and documentation necessary to demonstrate the conformity of the product with the requirements listed under paragraph 2 of this Article, in a language which can be easily understood by that authority.
Identification within the Supply Chain
Article 67
At the request of the Ministry:
1) The responsible persons shall identify the distributors to whom they supply the cosmetic products,
2) The distributor shall identify the distributor or the responsible person from whom, and the distributor to whom the cosmetic product was supplied.
This obligation shall apply for a period of three years following the date on which the batch of the individual cosmetic product was delivered to the distributor.
Article 68
A manufacturer shall bring its manufacturing process in line with the principles of good manufacturing practice.
Without prejudice to the provision of paragraph 1 of this Article, the manufacturer whose headquarters are located in the Republic of Serbia shall additionally bring his manufacturing process with the regulations governing in more detail the sanitary-technical and hygienic requirements in production and circulation, with the aim of ensuring a high level of protection of human life and health.
Compliance with good manufacturing practice shall be presumed where the manufacture is in accordance with the relevant harmonized standards.
Article 69
A sanitary inspector may not, due to the reasons related to the requirements of this Law, refuse, prohibit or restrict the delivery to the market of cosmetic products which comply with the requirements of this Law.
3. Safety Assessment, Product Information File
Article 70
For the purpose of demonstrating that a cosmetic product complies with Article 63 of this Law, the responsible person shall ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information prior to placing on the market, as well as that a cosmetic product safety report has been drawn up.
The responsible person shall ensure that:
1) The intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in the final formulation have been taken into account during the safety assessment of the cosmetic product,
2) An appropriate weight-of-evidence approach has been used during the safety assessment i.e. during review of data collected from all available sources,
3) The cosmetic product safety report is regularly updated by additional relevant information collected subsequent to placing of the cosmetic product on the market.
Provisions of this Article shall apply to all the cosmetic products appearing on the market.
Non-clinical safety studies referred to in the safety assessment according to paragraph 1 of this Article and carried out for the purpose of assessing the safety of a cosmetic product must comply with the EU legislation on the principles of good laboratory practice which were applicable at the time of preparation of the study, or with other international standards recognised as being equivalent by the European Commission or by the European Chemicals Agency.
Cosmetic Product Safety Assessor
Article 71
Safety assessment of a cosmetic product prescribed in more detail by the secondary legislation regulating the field of cosmetic products must be carried out by a person in possession of a legal instrument in the field of higher education in the field of pharmacy, medicine, toxicology or a similar equivalent discipline or education which may be recognized as equivalent in line with the regulations governing higher education.
Article 72
When a cosmetic product is placed on the market, the responsible person shall keep a Product Information File (PIF). The Product Information File shall be kept for a period of ten years following the moment the last batch of the cosmetic product has been placed on the market .
The responsible person shall make the Product Information File easily accessible to a sanitary inspector, in electronic or some other format, at the address indicated on the label.
At the request of a sanitary inspector, for the purpose of supervision, the responsible person must make available the translated parts of the Product Information File.
A sanitary inspector shall handle the information referred to in paragraphs 2 and 3 of this Article that comprise a trade secret of the manufacturer in compliance with the regulations governing protection of a trade secret.
Provisions of this Article shall pertain to all cosmetic products which are appearing on the market.
Article 73
It shall be prohibited to place on the market of the Republic of Serbia a cosmetic product, where the final formulation thereof has been subject to animal testing, or which contains ingredients or a combination of ingredients which, intended exclusively for application in cosmetic products, in order to meet the requirements of this Law and the secondary legislation regulating the field of cosmetic products, have been subject of animal testing using a method other than an alternative method validated by the Organisation for Economic Cooperation and Development (OECD).
The performance of animal testing of a cosmetic product, its ingredients or a combination of ingredients intended exclusively for application in cosmetic products in order to meet the requirements of this Law and the secondary legislation regulating the field of cosmetic products shall be prohibited in the Republic of Serbia.
By way of exception, where there are reasonable grounds to suspect the safety of a cosmetic product or its ingredient, the Ministry may grant a derogation from the requests indicated in paragraph 1 of this Article.
The derogation may be granted only:
1) Where the ingredient is in wide use and cannot be replaced by another ingredient having a similar effect,
2) Where a specific health problem exists, substantiated by evidence, so that the need to conduct animal tests is justified and there is a detailed research protocol as the basis for the evaluation.
Article 74
Cosmetic products which are delivered to the market of the Republic of Serbia must bear a label in Serbian language in compliance with this Law and the secondary legislation regulating the field of cosmetic products.
Product-Related Claims (Statements)
Article 75
When marking cosmetic products (for the purpose of making them available on the market and advertising) text, names, trademarks, pictures or other signs must not be used to imply that these products have characteristics which they do not have.
Information available to the Public
Article 76
Without prejudice to the right to protection of official secret and of the intellectual property rights, the responsible person must make easily accessible to the public by any appropriate means the following information:
1) The qualitative and quantitative composition of the cosmetic product,
2) The name and code number of the composition and the identity of the supplier (in the case of perfumes and aromatic compositions),
3) Existing data on undesirable effects and serious undesirable effects resulting from use of the cosmetic product.
The information regarding quantitative composition of the cosmetic product required to be made publicly accessible must be limited to hazardous substances in accordance with the regulations governing the field of chemicals.
Reporting Serious Undesirable Effects
Article 77
The responsible person and distributors shall without delay notify the Ministry of occurrence of a serious undesirable effect and specifically:
1) Of all undesirable effects which are known to him or which may reasonably be expected to be known to him,
2) Of the name of the cosmetic product concerned, enabling its identification,
3) Of the corrective measures taken (if he took any).
Where a distributor, the final consumer or a healthcare worker reports a serious undesirable effect to the Ministry, the Ministry shall, without delay, transmit that information to the responsible person.
The Ministry may use the information on undesirable effects for the purposes of market supervision, market analysis, evaluation, as well as for the purposes of informing the consumers.
Article 78
In the event of serious doubt regarding the safety of any substance contained in cosmetic products, the Ministry may, by means of a reasoned request, require the responsible person to submit a list of all cosmetic products for which he is responsible and which contain the substance concerned. The list must indicate the concentration of the substance concerned in the cosmetic products.
The Ministry may use the information referred to in this Article for the purposes of market supervision, market analysis, evaluation (assessment) and consumer information.
X MATERIALS AND ARTICLES INTENDED, WHEN USED, TO COME INTO DIRECT CONTACT WITH SKIN I.E. MUCOUS MEMBRANE, IRRESPECTIVE OF WHETHER THE INTEGRITY THEREOF IS IMPAIRED OR NOT
Notion
Article 79
Materials and articles that, when used, come into direct contact with skin i.e. mucous membrane, irrespective of whether the integrity thereof is impaired or not (hereinafter referred to as: materials and articles that, when used, come into direct contact with skin i.e. mucous membrane) shall be:
1) Materials and articles that, when used in accordance with their intended purpose and under reasonably foreseeable circumstances, come into direct contact with skin i.e. mucous membrane and do not impair their integrity shall be:
(1) The articles used as means for maintaining personal hygiene, care and embellishment of face and body (which, by their intended purpose do not belong to the cosmetic products),
(2) The articles made of textile, leather and other materials that come into direct contact with skin or mucous membrane,
2) Materials and articles which, when used in accordance with their intended purpose and under reasonably foreseeable circumstances, come into direct contact with skin or mucous membrane and impair the integrity thereof shall mean:
(1) Colors and pigments for tattoos, articles and props for embellishment of face and body, piercing and imitation of jewelry.
Article 80
Materials and articles which, when used, come into direct contact with skin i.e. mucous membrane that are delivered to the market must comply with the health i.e. safety requirements and comply with the requirements set by this Law and the secondary legislation regulating the field of materials and articles which, when used, come into direct contact with skin i.e. mucous membrane irrespective of whether the integrity thereof is impaired or not, with the aim of ensuring a high level of protection of human life and health and protection of consumer interests.
Without prejudice to the law and secondary legislation regulating the field of the products of general use, for the purpose of assessing compliance with the health i.e. safety requirements of the products of general use, measures can be applied which are based on scientific principles, Serbian, European and international standards, guidelines and recommendations, to the extent necessary to protect human life and health and to protect the environment.
XI DETERGENTS, BIOCIDES AND OTHER AGENTS FOR GENERAL USE AND MAINTENANCE OF HYGIENE
Notion
Article 81
Detergents, biocides and other agents for general use and maintenance of hygiene are agents used for the purpose of maintaining general hygiene, washing and refining textiles, washing and disinfection of hard surfaces, dishes, cutlery, devices, instruments, air freshening, etc.
These products must fulfill the requirements prescribed by this Law and the regulations governing the field of chemicals and biocidal products.
Detergents, biocides and other agents for general use and maintenance of hygiene must comply with the manufacturer’s specification, data included in the safety data sheet, in compliance with the intended purpose and the scope of application and requirements of the secondary legislation regulating the field of detergents and biocides.
XII TOBACCO, TOBACCO PRODUCTS, ACCESSORIES FOR THE USE OF TOBACCO PRODUCTS, ELECTRONIC CIGARETTE AND OTHER SYSTEMS FOR VAPOR INHALATION WITH OR WITHOUT NICOTINE
Notion
Article 82
Tobacco products which are as such defined by the regulations governing the field of tobacco and are intended for smoking, sniffing, sucking or chewing or inhaling of vapor with nicotine, even where they are partially made of tobacco, with or without nicotine.
Article 83
Tobacco products which are made available on the market of the Republic of Serbia must be compliant with the regulations governing permitted microbiological composition, composition of pesticides’ residue, heavy metals, radionuclides and other polluting substances from the environment, other substances and mixtures added in the manufacturing process the quantities of which are limited or prohibited by regulations (additives, flavorings, preservatives, etc.) and must comply with the requirements prescribed by this Law and the secondary legislation regulating the field of tobacco, tobacco products, accessories for the use of tobacco products, electronic cigarette and other systems for inhaling vapor with or without nicotine.
Tobacco products are products which, by their quality, comply with the standards prescribed by the law, and specifically: cigars, cigarillos, cigarettes, smoking tobacco and other tobacco products, in compliance with the regulations governing the field of tobacco.
Accessories for the use of tobacco products (applicators, mouthpieces, smoke and aerosol inhalators, mixtures which come into contact with mouth, skin and mucous membrane), classic and new tobacco products must comply with the health i.e. safety requirements in accordance with the secondary legislation regulating in more detail the field of tobacco, tobacco products, accessories for the use of tobacco products, electronic cigarette and other systems for inhalation of vapor with or without nicotine.
Article 84
Tobacco products, accessories for use of tobacco products and packaging (primary packaging) used in packing of tobacco products which are made available on the market must be marked, labeled, advertised and presented in compliance with the laws regulating the field of tobacco and the field of advertising.
Product information and label must be indelible, easily perceivable, legible, intelligible and written in Serbian language.
Article 85
The monitoring system in the field of products of general use is monitoring the application of laws and regulations in the field of compliance with the health i.e. safety requirements of the products of general use in production and circulation.
Article 86
Monitoring the implementation of this Law shall be conducted by the Ministry, through the sanitary inspectors.
In the course of inspection supervision, in order to determine the decisive facts, in addition to direct examination in the establishments or in other places of control, the sanitary inspector shall conduct examination of the documentation, physical i.e. organoleptic examination of the characteristics of the product of general use, take samples for laboratory testing where necessary i.e. where it is not possible to determine product safety in some other manner, taking into account at the same time the established principles of risk assessment, request of the client, objections and other available information.
Areas of Significance for Conducting supervision of Products of General Use
Article 87
The areas of significance for conducting sanitary supervision over products of general use shall be:
1) Supervision of production of the products of general use,
2) Supervision of circulation and use of products of general use,
3) Monitoring,
4) Sampling for the needs of sanitary supervision,
5) Laboratories,
6) Mandate, rights and duties of sanitary inspectors.
Article 88
Production supervision shall include the control of:
1) Implementation of internal control by the manufacturer,
2) Conditions of production, as well as control of all the stages of the production process,
3) The finished product, including, where necessary, taking samples for analysis,
4) Implementation of the monitoring program.
When conducting supervision over materials and articles intended to come into contact with food, provisions on official control of the law that governs the field of food safety shall be applied accordingly.
2.1. Supervision of Delivery on the Market
Article 89
Only the products which are compliant with the health i.e. safety requirements may be delivered on the market of the Republic of Serbia.
Operators in the business of products of general use shall possess proof of products’ compliance with the health i.e. safety requirements, prescribed for each group of products of general use.
2.2. Supervision of Imports for Placing on the Market and Exports Supervision
Application for Examination of Consignment for Import
Article 90
Prior to customs clearance of a consignment for import, the importer shall submit a written application for examination of the consignment to the border sanitary inspector competent for the border area in the place where customs clearance is conducted, in order to determine its compliance with the health i.e. safety requirements.
The importer may submit the application referred to in paragraph 1 of this Article directly or through a customs representative.
Enclosed with the application referred to in paragraph 1 of this Article, the importer shall submit prescribed and required evidence relevant for identification of products and determining of compliance with the health i.e. safety requirements of the product to be imported.
The importer shall allow the border sanitary inspector to inspect the documentation and to conduct unobstructed sanitary supervision of the products during the import.
The costs incurred in the procedure of sanitary supervision conducted at the request of the client shall be borne by the applicant in compliance with the regulation governing administrative duties.
Decision of the Border Sanitary Inspector
Article 91
The border sanitary inspectors shall pass a decision on fulfillment of the prescribed conditions concerning compliance with the health i.e. safety requirements of the products of general use to be imported.
The border sanitary inspectors shall issue a decision to prohibit the import of the products of general use which are non-compliant with the health i.e. safety requirements and order the measure of their return to the sender.
By way of exception, at the request of the importer, the border sanitary inspector shall be authorized to issue a decision, in compliance with the law, ordering the measure of destruction of products of general use which are non-compliant with the health i.e. safety requirements, if the consignment, due to duly justified reasons, cannot be returned to the sender.
The border sanitary inspector shall pass the decision referred to in paragraphs 1, 2 and 3 of this Article within eight days from the date of conclusion of the inspection supervision procedure.
Cooperation with Customs Authority when importing Products
Article 92
The customs authority may not complete the customs clearance of a consignment i.e. product without a decision of the border sanitary inspector referred to in Article 91, paragraph 1 of this Law.
The customs authority shall enable the implementation of the decision of the border sanitary inspector and provide expert assistance in enforcement of the decision referred to in Article 91, paragraphs 2 and 3 of this Law.
Customs Clearance of Products Prior to Passing of a Decision of the Border Sanitary Inspector
Article 93
By way of exception to the provision of Article 92, paragraph 1 of this Law, prior to passing of a decision of the border sanitary inspector referred to in Article 91, paragraph 1 of this Law, at the request of the importer, upon obtaining the written consent from the border sanitary inspector (hereinafter referred to as: the consent), the customs authority may complete the customs clearance during importing of a product that has been subjected to laboratory tests in the procedure of sanitary supervision, the results of which are not yet known.
The consent referred to in paragraph 1 of this Article shall be issued to the importer based on the written application submitted to the border sanitary inspector in the place of customs clearance. This application must include information on the place and conditions of storage, on other conditions of significance for preservation of compliance with the health i.e. safety requirements of the product, transportation method and obligations of the storekeeper and users in securing the product until the conclusion of the sanitary supervision procedure.
The importer referred to in paragraph 1 of this Article may not deliver to the market, process or in any other manner dispose of or remove the product from the notified storage until the conclusion of the sanitary supervision procedure and passing of the decision referred to in Article 91 of this Law.
Where following the conclusion of the sanitary supervision procedure the border sanitary inspector passes the decision referred to in Article 91, paragraphs 2 and 3 of this Law, the costs of implementation of the decision shall be borne by the importer.
Sanitary Supervision of Products in Free Trade Zones
Article 94
Provisions of this Law shall additionally apply to the products imported for the purpose of placing in circulation in a free trade zone.
Supervision of Products of General Use during Exporting
Article 95
Inspection supervision of the products of general use which are exported shall be conducted by the sanitary inspectors in the place of production, i.e. place of loading thereof for the purpose of exporting, at the requests of the business operator.
Article 96
At the proposal of the Institute of Public Health of Serbia, the Minister shall pass a Monitoring Program by 30 September of the current year at the latest for the following year.
Based on the Program referred to in paragraph 1 of this Article, the institutes and organizations of public health shall pass the implementing plans for the Monitoring Program in the territory for which they are established, by 31 December of the current year at the latest for the following year and shall implement them in cooperation with the sanitary inspection.
The funds for the implementation of the Program referred to in paragraph 1 of this Article shall be provided in the budget of the Republic of Serbia.
The Monitoring Program and the monitoring implementing plans shall be made publicly available by electronic means or, where appropriate, in some other manner.
Article 97
The Institute of Public Health of Serbia shall, based on the results of implemented Monitoring Program, deliver to the Ministry a report on compliance with the health i.e. safety requirements of the products of general use in the territory of the Republic of Serbia inclusive of an expert analysis and proposal of measures, by 31 July of the current year at the latest for the first six months and by 31 January of the following year for the previous year.
Article 98
The samples taken in the monitoring procedure must be taken, packed and delivered to the laboratory in the prescribed manner.
The sanitary inspector shall prepare minutes on sampling of products of general use, regarding the samples taken in the course of the monitoring procedure.
Operators in the business of products of general use shall place at the disposal of the sanitary inspector, free of charge, the necessary quantities of samples for laboratory testing in compliance with the law, as well as other necessary documentation relating to the composition and intended purpose of the samples and other information of relevance.
The laboratory testing in the procedures referred to in paragraph 1 of this Article conducted at the order of a sanitary inspector shall be performed by the approved laboratories of the institutes and organizations of public health.
4. Sampling for the Needs of Sanitary Supervision
Sampling in the Course of the Supervision Procedure
Article 99
When conducting supervision of the products of general use, the sanitary inspector shall be authorized to take samples of the products of general use in the prescribed manner, for the purpose of laboratory testing aimed at determining compliance with the health i.e. safety requirements in cases where it is not possible to determine product safety in some other manner, taking into account at the same time the principle of the assessment of risk, the request of the client, objections and other available pieces of information.
The sanitary inspector shall prepare minutes on performed sampling regarding the samples taken and referred to in paragraph 1 of this Article, as well as to define the type and parameters for the laboratory testing in the order for laboratory testing.
Upon order of the sanitary inspector, the laboratory testing in the procedures referred to in paragraph 1 of this Article shall be performed by the approved laboratories.
Following a completed testing, the approved laboratory to which the sample has been sent for testing shall issue a testing report.
The approved laboratory that has performed the testing shall issue an expert opinion with the testing report. The expert opinion must include the opinion of a medical doctor specializing in the field of public health on whether the sample tested is compliant with the health i.e. safety requirements, and where it is non-compliant, the reason for its non- compliance, as well as other pieces of information prescribed. The test report for the samples taken in the official control procedures can only be used for the needs of sanitary supervision.
The sampling procedure for the needs of sanitary supervision shall be conducted in compliance with the law regulating general administrative procedure and the law regulating inspection supervision.
Article 100
Operators in the business of products of general use shall place at the disposal of the sanitary inspector, free of charge, the needed quantities of samples in compliance with the law, for the purpose of laboratory testing aimed at determining the compliance with the health requirements.
Article 101
The sanitary inspector shall communicate the test result of the compliance with the health i.e. safety requirements of the sample to the operator in the business of products of general use in writing.
The operator in the business of products of general use shall, for the products which have been determined to be non-compliant with the health requirements by means of laboratory testing, be entitled to request (in writing) from the sanitary inspector performance of a super analysis, within three days from the date of receipt of the notification.
The sample for super analysis shall be taken at the same time, in the same manner and under the same conditions as the sample for analysis and shall be tested by using the same method as, or a method of a higher sensitivity than in the analysis, in the laboratories approved for performing super analysis and in such cases, the result of the super analysis shall prevail.
Article 102
The sanitary inspector shall order a ban on production i.e. circulation in accordance with the law when it is determined in production i.e. circulation that a product of general use is not compliant with the health i.e. safety requirements.
The measure prohibiting circulation of the products of general use which are non-compliant with the health i.e. safety requirements shall be imposed against a business operator found to be in possession of such products of general use.
Costs of Laboratory Testing of the Samples
Article 103
The costs of determining compliance with the health i.e. safety requirements of a product prior to making it available on the market of the Republic of Serbia referred to in Article 89, paragraph 2 of this Law shall be borne by the supervised operator.
Any costs of testing of the compliance with the health i.e. safety requirements of a product during its importing shall be borne by the importer.
The costs of laboratory testing of the samples taken in the course of the sanitary supervision procedure referred to in Article 99, paragraph 1 of this Law shall be borne by the operator that is subject to supervision, where it is determined that they are non-compliant.
The costs of laboratory testing of the samples taken in the course of a sanitary supervision procedure referred to in Article 99, paragraph 1 of this Law shall be borne by the Ministry where it is determined that they are compliant.
Issuing of the Health Certificate and Free Sale Certificate
Article 104
The sanitary inspector shall be authorized to issue, at the request of a client, a Health Certificate and a Free Sale Certificate in the territory of the Republic of Serbia, for the needs of exporting of the products of general use, in compliance with the law regulating sanitary supervision.
Article 105
Laboratory testing of the compliance with the health i.e. safety requirements of the products of general use may be performed by:
1) The internal manufacturer’s laboratory for control of own production process,
2) The laboratory accredited for sanitary supervision of products of general use (hereinafter: the approved laboratories),
3) The reference laboratory.
The laboratories referred to in paragraph 1, items 2) and 3) of this Article must be accredited according to SRPS ISO/IEC 17025 Standard and authorized by means of a decision of the Minister.
The Minister shall establish, by means of a decision, the Commission for Verification of Compliance with Requirements in respect of the staff, premises and equipment of an authorized laboratory and reference laboratory for testing of compliance with the health i.e. safety requirements of the products of general use (hereinafter: the Laboratory Commission).
Based on the minutes drawn up by the Laboratory Commission, the Minister shall pass a decision on granting authorization to the accredited laboratory for testing of compliance with the health i.e. safety requirements of the products of general use, for a period of five years.
The Minister shall revoke the authorization referred to in paragraph 4 of this Article by means of a decision in case that the Laboratory Commission determines that a laboratory has ceased to comply with the requirements based on which the authorization has been granted.
The decisions referred to in paragraphs 4 and 5 of this Article shall be published in the “Official Herald of the Republic of Serbia”.
The Ministry shall keep records of the issued and revoked laboratory authorizations. The records shall comprise the list of laboratories to which authorization has been granted inclusive of the date and number of the decision, as well as the list of laboratories whose authorization has been revoked inclusive of the date and number of the decision and the reasons why the authorization has been revoked, in compliance with the law regulating general administrative procedure.
The decision on granting and revoking of laboratory authorization shall be final in administrative procedures and administrative dispute can be initiated against such decision.
The authorized laboratories referred to in paragraph 1, item 2 of this Article shall deliver to the Ministry and to the Institute of Public Health of Serbia semi-annual and annual reports on the compliance with the health i.e. safety requirements i.e. conformity of the samples of the products of general use taken in the course of sanitary supervision.
Article 106
Apart from the laboratories referred to in Article 105, paragraph 1, item 2) of this Law, services of accredited laboratories outside of the Republic of Serbia may be used for analyses of the samples taken in the course of sanitary supervision for the specific parameters for which there is no laboratory in the Republic of Serbia.
6. Powers, Rights and Duties of the Sanitary Inspector
Article 107
In conducting inspection supervision of the production and circulation of the product of general use, the sanitary inspector shall have the right and duty to take the following measures:
1) To temporarily ban production i.e. circulation of the products of general use, when he doubts their compliance with the health i.e. safety requirements, until it is found by means of laboratory testing that they are compliant with the health i.e. safety requirements,
2) To prohibit production, circulation and use of products of general use which are not compliant with the health i.e. safety requirements,
3) To order destruction of the products of general use which are not compliant with the health i.e. safety requirements in a manner that is safe and not injurious, in compliance with the law,
4) To order that the products of general use which are not compliant with the health i.e. safety requirements be withdrawn from the market,
5) To order the producer to withdraw the products of general use which are not compliant with the health i.e. safety requirements in cases where that constitutes jeopardizing of the interest of public health,
6) To order the operator in the business of products of general use to inform the consumers of the withdrawal of the products of general use which are not compliant with the health i.e. safety requirements,
7) To prohibit the import of products of general use which are not compliant with the health i.e. safety requirements and to order that they are returned to sender,
8) To prohibit the import of products of general use which are not compliant with the health requirements and to order that they are destroyed if they cannot be returned to sender in compliance with this Law,
9) To order that the deficiencies found in the premises for production i.e. circulation of products of general use are removed and to set the time limit for the removal thereof,
10) To temporarily prohibit the use of premises, devices and equipment used in production and circulation of products of general use if the prescribed sanitary requirements have not been complied with, until the same are complied with,
11) To order that the authorized laboratories provide reports on the compliance with the health i.e. safety requirements of the samples of the products of general use taken in the course of sanitary supervision,
12) To impose other measures and to take other actions in compliance with the law.
The measures consisting of orders and prohibitions referred to in paragraph 1 of this Article shall be imposed by means of a decision of the sanitary inspector passed in the administrative procedure.
Article 108
The operators in the business of products of general use shall comply with the administrative measure of the sanitary inspector within the time limit set in the minutes i.e. in the decision.
Sanitary inspectors may also order taking of extremely urgent emergency measures in order to eliminate immediate hazard to human life and health by means of an oral decision, in compliance with the law.
The oral decision referred to in paragraph 2 of this Article must be recorded in the minutes of the completed inspection supervision.
Article 109
An appeal can be filed against a decision of a sanitary inspector within eight days from the day of serving of the decision.
The appeal shall not have a suspensive effect on enforcement of the decision.
The Minister shall decide upon the appeal against the decision of the sanitary inspector passed in the first instance.
The decision referred to in paragraph 3 of this Article shall be final.
Harmonization with European Union Legislation
Article 110
This Law is harmonized with all the principles and elements of significance from the relevant European legislation: Regulation (EC) No. 1935/2004 of the European Parliament and Council of 27 October, 2004 on materials and articles intended to come into contact with food and Regulation (EC) No. 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food, Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys; Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
Economic Offense of the Operator in the Business of Products of General Use
Article 111
A fine ranging from 300,000 to 3,000,000 Dinars shall be imposed for an economic offense against a legal person where it:
1) Delivers to the market of the Republic of Serbia a product of general use which is not compliant with the health i.e. safety requirements i.e. compliant (Article 15, Article 40, paragraph 1).
The responsible person with the legal person shall be sanctioned for the economic offense referred to in Article 1 of this paragraph as well with a fine ranging from 50,000 to 200,000 Dinars.
а) Misdemeanors of the Operator in the Business of Products of General Use
Article 112
Legal person shall be sanctioned with a fine amounting to 300,000 Dinars for a misdemeanor if it:
1) Attributes a medicinal property to a product of general use (Article 18, paragraph 1, item 1);
2) Falsely label i.e. advertise a product of general use in a manner which is misleading for the consumer in respect of the actual composition, a characteristic or the intended purpose of these products (Article 18, paragraph 1, item 2);
3) Based on a written notice of the Ministry or a sanitary inspector that there are reasonable grounds to doubt the compliance of a product of general use with the health i.e. safety requirements, fails to take adequate actions, proportionate to the risk involved and notify the Ministry i.e. the sanitary inspector and the general public thereof in writing, in compliance with the law (Article 21, paragraph 1);
4) For the products of general use, for which there are reasonable grounds to doubt their compliance with the health i.e. safety requirements, which have changed the owner, it fails to take adequate actions which are proportionate to the risk involved and notify the Ministry and the general public thereof in writing (Article 21, paragraph 2);
5) Based on the written notice of the Ministry or a sanitary inspector that a product of general use is not complying with the health i.e. safety requirements, it fails to take adequate actions which are proportionate to the risk involved and notify the Ministry i.e. the sanitary inspector and the general public thereof in writing, in compliance with the law (Article 22, paragraph 1);
6) It fails to inform the consumers in an efficient and clear manner of the reason for recall of the product of general use which have been found to be non-compliant with the health i.e. safety requirements, and which have reached the consumers, and, where necessary, fails to request that the consumers return the product of general use which have already been supplied to them, where the high level of protection of health cannot be achieved by means of other measures, and to notify the Ministry and the general public thereof in writing (Article 22, paragraph 2);
7) Fails to inform the sanitary inspector in writing of the place, date and the destroyed quantity of the products of general use which are non-compliant with the health i.e. safety requirements and fails to provide evidence that they have been destroyed in a manner that is safe and not harmful to human health and the environment in compliance with the regulations governing the field of waste management (Article 22, paragraph 5);
8) Fails to put in place and conduct, in a documented manner, in compliance with its business activity, internal control in all stages of production and circulation, in compliance with the principles of good manufacturing practice, good hygienic practice, manuals, as well as analyses of hazards and control of critical spots by analysis of hazards and critical control spots (Article 24, paragraph 2);
9) Materials and articles intended to come into contact with food are not labeled in compliance with this Law and the secondary legislation regulating the field of materials and articles intended to come into contact with food and if such marking is not written in Serbian language (Article 30);
10) Does not issue a declaration of conformity and if such declaration does not include information prescribed by the secondary legislation regulating the field of materials and articles intended to come into contact with food is (Article 31, paragraph 2);
11) Does not have in place systems and procedures which are allowing identification of the business operators from which and to which materials or articles intended to come into contact with food are supplied, and, where appropriate, substances or products covered by this legislation and its implementing measures used in their manufacture and if it fails to make available such information to the Ministry on demand (Article 32, paragraph 2);
12) Does not possess adequate documentation whereby it proves that the materials and articles intended to come into contact with food, products from the intermediary stages of the production thereof and substances envisaged for production of such materials and articles are in compliance with the requirements of this Law and the secondary legislation regulating this field (Article 32, paragraph 4);
13) The documentation whereby it proves that the materials and articles intended to come into contact with food, products from the intermediary stages of the production thereof and substances envisaged for production of such materials and articles in compliance with the requirements of this Law and the secondary legislation regulating this field does not include the test conditions and results, calculations, including modeling, other analyses and proof of compliance with the health i.e. safety requirements or an explanation that proves conformity (Article 32, paragraph 5);
14) Does not possess relevant declaration of conformity which, among other things, comprise an additional piece of information that only the recycled plastic obtained in an approved recycling procedure is used in manufacturing thereof, indicating at the same time the number of the approval, as well as other pieces of information on the conformity of the material with this Law and with the secondary legislation regulating the field of materials and articles intended to come into contact with food (Article 32, paragraph 6);
15) Does not ensure that the that the manufacturing operations are conducted in compliance with the general rules on good manufacturing practice defined by the quality assurance system, quality control system and appropriate establishing and maintenance of relevant documentation and the detailed rules on good manufacturing practice prescribed by the secondary legislation regulating the field of materials and articles intended to come into contact with food in the part relating to the use of printing inks, recycled materials or other materials (Article 35);
16) Does not establish, apply and maintain an effective and documented quality assurance system (Article 36, paragraph 1);
17) Does not establish and maintain effective the quality control system (Article 37, paragraph 1);
18) Does not prepare and maintain appropriate documentation in paper or electronic format which relates to specifications, manufacturing formulae and processing which are relevant for compliance and safety of the finished material or article, if the same does not include taking notes of various manufacturing operations performed which are relevant to compliance with the prescribed requirements and safety of the finished material or article, with respect given to the results of the quality control system and if it does not provide the said documentation for inspection to the sanitary inspector, at his request (Article 38);
19) When placing the toys on the market, does not ensure that the toys have been designed and manufactured in accordance with the essential safety requirements and particular safety requirements set out in this Law and the secondary legislation regulating the field of toy safety (Article 40, paragraph 1);
20) Does not draw up the required technical documentation in the manner prescribed by the secondary legislation regulating the field of toy safety and if it fails to carry out the prescribed conformity assessment procedure, in accordance with this Law (Article 40, paragraph 2);
21) In cases where compliance of a toy with the relevant requirements has been demonstrated in the prescribed procedure, a declaration of conformity has not been drawn up, and the marking of conformity has not been affixed, in the manner prescribed by this Law (Article 40, paragraph 2);
22) Fails to keep the technical documentation and the declaration of conformity for a period of ten years after the toy has been placed on the market of the Republic of Serbia (Article 40, paragraph 3);
23) Fails to ensure existence of procedures whereby the series production remains in conformity (Article 40, paragraph 4);
24) Where necessary in respect of the toys posing a risk, and to protect the health and safety of consumers, does not conduct testing of the samples of toys which are placed on the market, does not explore and does not maintain the register of complaints and register of non-compliant toys and of the returned toys and if it does not inform the distributors of such monitoring (Article 40, paragraph 4);
25) Fails to ensure that their toys bear a type, batch, serial or model number or other element allowing their identification, or, where the size or nature of the toy does not allow it, that the required information is provided on the packaging (or in a document accompanying the toy) (Article 40, paragraph 5);
26) Fails to indicate its name, registered trade name or registered trade mark and the address at which it can be contacted on the toy or, where that is not possible, on the toy’s packaging or in a document accompanying the toy (Article 40, paragraph 6);
27) Fails to enclose with the toy complete information and documentation in Serbian language, required to demonstrate conformity of the toy in question (Article 40, paragraph 6 and Article 47);
28) Considers or has reason to believe that a toy which it has placed on the market is not in conformity with the provisions of this Law and of the secondary legislation regulating the field of toy safety, fails to immediately take the measures necessary to bring that toy into conformity, to withdraw it from the market or recall it and if it fails to immediately notify the Ministry thereof (Article 40, paragraph 7);
29) Further to the justified requests from the Ministry, fails to enclose complete information and documentation necessary to demonstrate the conformity of the toy in question, in Serbian language and it it fails to cooperate with the Ministry as regards any action taken which is aimed at eliminating the risks posed by the toy which it has placed on the market (Article 40, paragraph 8);
30) Does not keep the declaration of conformity for a period of ten years after the moment the toy has been placed on the market and, if, at the request of the sanitary inspection, fails to show the declaration of conformity and provide access to technical documentation (Article 41, paragraph 3, item 1);
31) Further to a request from the Ministry, fails to provide complete information and documentation necessary to demonstrate the conformity of the toy in question (Article 41, paragraph 3, item 2);
32) At the request of the Ministry, fails to cooperate on all the actions taken with the aim of eliminating the risks posed by toys covered by the mandate given to it (Article 41, paragraph 3, item 3);
33) Places on the market of the Republic of Serbia the toys which are not compliant with this Law and the secondary legislation passed based on this Law (Article 42, paragraph 1);
34) Prior to placing a toy on the market, fails to ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer and that the manufacturer has drawn up the technical documentation, that the toy has been marked with the required conformity marking and that the toy is accompanied by the required documents, as well as that the manufacturer has complied with the requirements referred to in Article 40, paragraphs 5 and 6 of this Law; (Article 42, paragraph 2);
35) Fails to inform the manufacturer and the sanitary inspection that a toy presents a risk (Article 42, paragraph 2);
36) Fails to indicate its name, registered trade name or registered trade mark and the address at which it can be contacted on the toy or, where that is not possible, on the toy’s packaging or in a document accompanying the toy (Article 42, paragraph 3);
37) Fails to enclose with the toy instructions and safety information in Serbian language (Article 42, paragraph 4);
38) Fail to ensure that, while a toy is under its responsibility, storage or transport conditions do not jeopardize the compliance of such toy with the essential safety requirements and particular safety requirements prescribed by this Law and the secondary legislation regulating the field of toy safety (Article 42, paragraph 5);
39) When that is necessary due to the risk a toy presents, and with the aim of protecting the health and safety of consumers, fails to carry out sample testing of toys placed on the market, fails to investigate, and, where necessary, keep a register of complaints and of non-conforming toys and toys that have been recalled, and fails to keep distributors informed of all that (Article 42, paragraph 6);
40) Fails to immediately take the corrective actions necessary to bring the toy it has placed on the market into conformity, which it believes or has reason to believe that it is not in conformity with the provisions of this Law and the secondary legislation regulating the field of toy safety, to withdraw it from the market or recall it, if necessary and if it fails to immediately inform the Ministry thereof (Article 42, paragraph 7);
41) Fails to keep a copy of the declaration of conformity for a period of ten years after the toy has been placed on the market, and at the request of the sanitary inspection, fails to make available for inspection the declaration of conformity and to provide access to technical documentation (Article 42, paragraph 8);
42) Further to a reasoned request from the Ministry, fails to enclose complete information and documentation in Serbian language, necessary to demonstrate the conformity of the toy in question, and if it fails to cooperate with the Ministry on all the actions taken with the aim of eliminating the risks posed by the toy which it has placed on the market (Article 42, paragraph 9);
43) Prior to making a toy available on the market, fails to verify that the toy bears the required conformity marking, that it is accompanied by the required documents, instructions and safety information in Serbian language, as well as that the manufacturer and the importer have complied with the requirements set out in Article 40, paragraphs 5 and 6 of this Law and in Article 42, paragraph 3 (Article 43, paragraph 2);
44) It places a toy on the market for which it deems or has reason to believe that is not in conformity with the essential safety requirements and with the particular safety requirements prescribed by this Law and the secondary legislation regulating the field of toy safety, before the same has been brought into conformity and fails to inform the manufacturer or the importer thereof, as well as the sanitary inspection (Article 43, paragraph 2);
45) Fails to ensure that, while a toy is under its responsibility, storage or transport conditions do not jeopardize the compliance of the toy with the essential safety requirements and with the particular safety requirements prescribed by this Law and the secondary legislation regulating the field of toy safety (Article 43, paragraph 3);
46) When it deems or has reason to believe that a toy which it has made available on the market is not in conformity with the provisions of this Law and of the secondary legislation regulating the field of toy safety, fails to immediately take the corrective actions necessary to bring that toy into conformity, to withdraw it from the market or recall it, where necessary and if it fails to immediately inform the Ministry thereof (Article 43, paragraph 4);
47) Further to a reasoned request from the Ministry, fails to provide complete information and documentation necessary to demonstrate the conformity of the toy in question and does not cooperate with the Ministry, as regards any action taken which are aimed at eliminating the risks posed by the toy which it has made available on the market (Article 43, paragraph 5);
48) At the request of the sanitary inspection, fails to provide information on any business operator who has supplied it with the toy i.e. the name of any business operator to whom it has supplied the toy (Article 45);
49) Fails to mark the warnings on toys, in compliance with the secondary legislation regulating the field of toy safety, and fails to enclose the warnings and safety instructions in Serbian language (Article 47);
50) Prior to placing the toy on the market, fails to carry out an analysis of hazards the toys might present in terms of chemical, physical, mechanical, electrical hazards and hazards related to flammability, hygiene and radioactivity, as well as if it fails to carry out an assessment of the potential exposure to such hazards (Article 53);
51) At a reasoned request of the sanitary inspection, fails to provide translation of the relevant parts of technical documentation into Serbian language (Article 56, paragraph 1);
52) The cosmetic product placed on the market is not in compliance with the obligations set out by this Law (Article 64, paragraph 2);
53) Prior to making a cosmetic product available on the market, fails to check all pieces of information indicated in Article 66, paragraph 2, items 1) - 5) (Article 66, paragraph 2);
54) Makes a cosmetic product, for which it deems or has grounds to believe that it is not in conformity with the requirements laid down in this Law, available on the market, prior to ensuring that it is in conformity with the applicable requirements of this Law and of the secondary legislation regulating the field of cosmetic products (Article 66, paragraph 3, item 1);
55) Where a cosmetic product which it has made available on the market is not in conformity with this Law, it fails to ensure that the corrective measures necessary to bring that product into conformity, to withdraw it from the market or recall it from the end user, as appropriate, are taken (Article 66, paragraph 3, item 2);
56) Fails to immediately inform the responsible person and the Ministry where a cosmetic product presents a risk to human health (Article 66, paragraph 4);
57) The storage or transport conditions jeopardize the compliance of a cosmetic product with the requirements set out in this Law while the product is under its responsibility (Article 66, paragraph 5);
58) Despite request of the Ministry, fails to cooperate with it on any action to eliminate the risks posed by the cosmetic product which it has made available on the market and where, while complying with the request from the Ministry, fails to provide complete information and documentation necessary to demonstrate conformity of the product with the requirements listed in Article 66, paragraph 2, in a language which can be easily understood by that authority (Article 66, paragraph 6);
59) Despite the request of the Ministry, fails to identify the distributors to whom it supplies the cosmetic products (Article 67, paragraph 1, item 1);
60) Despite the request of the Ministry, fails to identify the distributor or the responsible person from whom, and the distributor to whom, the cosmetic product was supplied (Article 67, paragraph 1, item 2);
61) Fails to bring its manufacturing process in line with the principles of good manufacturing practice and with the regulations governing in more detail the sanitary and technical and the hygienic requirements in production and circulation, with the aim of ensuring a high level of protection of human life and health (Article 68);
62) For the purpose of demonstrating that a cosmetic product complies with Article 63 of this Law, fails to ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information prior to placing on the market, as well as that a cosmetic product safety report has been drawn up in compliance with the secondary legislation regulating the field of cosmetic products (Article 70, paragraph 1);
63) The intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation have not been taken into account in the safety assessment of the cosmetic product (Article 70, paragraph 2, item 1);
64) An appropriate weight-of-evidence approach has not been used in the safety assessment i.e. in reviewing data collected from all the sources available (Article 70, paragraph 2, item 2);
65) The cosmetic product safety report has not been regularly updated with additional relevant information collected subsequent to placing of the cosmetic product on the market (Article 70, paragraph 2, item 3);
66) When a cosmetic product is placed on the market, the Product Information File is not kept for it, for a period of ten years following the moment of placing on the market of the last batch of the cosmetic product (Article 72, paragraph 1);
67) Fails to make the Product Information File easily accessible to the sanitary inspector, in electronic or some other format, at the address indicated on the label (Article 72, paragraph 2);
68) At the request of a sanitary inspector, for the purpose of supervision, fails to make available the translated parts of the Product Information File (Article 72, paragraph 3);
69) While marking the cosmetic products (for the purpose of making them available on the market and advertising) uses the text, names, trademarks, pictures or other signs with the aim of attributing the characteristics to these products which they do not have (Article 75);
70) Without prejudice to the right to protection of commercial secrecy and of the intellectual property rights, fails to make easily accessible to the public information on the qualitative and quantitative composition of the cosmetic product, the name and code number of the composition and the identity of the supplier (in the case of perfumes and aromatic compositions), as well as the existing data on undesirable effects and serious undesirable effects resulting from use of the cosmetic product (Article 76);
71) Fails to notify the Ministry without any delay of the occurrence of a serious undesirable effect and specifically of all undesirable effects which are known to it or which may reasonably be expected to be known to it; of the name of the cosmetic product concerned, enabling identification thereof; as well as of the corrective measures taken by it (if any) (Article 77, paragraph 1, items 1) - 3)).
The responsible person with the legal person shall also be sanctioned for the misdemeanor referred to in paragraph 1 of this Article with a fine amounting to 30,000 Dinars.
A sole trader shall be sanctioned for the misdemeanor referred to in paragraph 1 of this Article with a fine amounting to 100,000 Dinars.
b) Misdemeanors of the Appointed Body
Article 113
The appointed body shall be sanctioned with a fine amounting to 250,000 Dinars for a misdemeanor if it:
1) Grants a certificate of type examination for toys whose certificates have been refused or withdrawn (Article 55, paragraph 4);
2) Fails to inform the Ministry of all of the certificates which have been issued, amended, supplemented, suspended and withdrawn, as well as of the certificates whose issuance has been refused (Article 58, paragraph 2);
3) In addition, fails to notify other conformity assessment bodies appointed in compliance with this Law of the certificates which have been suspended, withdrawn or whose issuance has been refused, as well as of the certificates issued to the manufacturer i.e. to the authorized representative of the manufacturer, upon request (Article 58, paragraph 3);
4) Fails to deliver other pieces of relevant information on demand (Article 58, paragraph 4);
5) Finds that the essential requirements have not been met or that they are no longer met by a manufacturer, or that the certificate should not have been issued, in relation to the type and scope of the non-conformity, and fails to suspend, withdraw or restrict the certificate issued accordingly and to inform the Ministry thereof (Article 58, paragraph 5);
6) At the request of the Ministry, fails to provide relevant information and documentation, including the financial documentation required for the Ministry to verify compliance with the essential requirements relating to marking with the Serbian mark of conformity (Article 58, paragraph 6);
The responsible person with the appointed body shall also be sanctioned for the misdemeanor referred to in paragraph 1 of this Article with a fine amounting to 25,000 dinars.
c) Misdemeanors of the Authorized Laboratories
Article 114
The authorized laboratory shall be sanctioned with a fine amounting to 200,000 Dinars for a misdemeanor if it:
1) Fails to deliver to the Ministry the semi-annual and the annual reports on the compliance with the health i.e. safety requirements i.e. on the conformity of the samples of products of general use taken within the sanitary supervision (Article 105, paragraph 9);
2) Fails to deliver to the Institute of Public Health of Serbia the semi-annual and annual reports on the compliance with the health i.e. safety requirements i.e. on the conformity of the samples of products of general use taken within the sanitary supervision (Article 105, paragraph 9).
The responsible person with the authorized laboratory shall also be sanctioned for the misdemeanor referred to in paragraph 1 of this Article with a fine amounting to 20,000 Dinars.
XV TRANSITIONAL AND FINAL PROVISIONS
Article 115
The Minister in charge of the health-related matters shall pass the secondary legislation based on the powers referred to in this Law within 18 months from the date of entry into force of this Law.
Until the adoption of the regulations referred to in paragraph 1 of this Article, the regulations that were in force until the date of entry into force of this Law shall apply, provided that they are not contrary to this Law.
Article 116
Procedures initiated upon applications submitted to the Ministry until the date of entry into force of this Law shall be concluded under the regulations which were in force until the date of entry into force of this Law.
Article 117
The operators in the business of products of general use shall bring their operations in line with the provisions of Articles 70 and 72 of this Law within four years from the date of entry into force of this Law.
Article 118
As of the date of entry into force of the ratified international treaty on conformity assessment and acceptance of industrial products with the European Union (hereinafter referred to as: the АСАА), or, if that agreement is not concluded, as of the date of entry into force of the treaty of accession of the Republic of Serbia to the European Union, the expression "in Serbian language" shall be replaced by the expression "in the language easily understood by the competent authority and the consumer, i.e. the final user in the Member State of the European Union".
Article 119
As of the date of entry into force of the АСАА or, if that Agreement is not concluded, as of the date on entry into force of the treaty on accession of the Republic of Serbia to the European Union, the CE marking shall be affixed instead of the Serbian marking of conformity to the products to which the harmonized legislation of the EU applies.
Article 120
(Deleted)
Article 121
As of the date of entry into force of the treaty of accession of the Republic of Serbia to the European Union, provisions regulating sanitary supervision during import for the purpose of delivery to the market and supervision during export shall apply only to products imported from the third countries or to the products exported to the third countries.
Article 122
As of the day of entry into force of this Law, the Law on Health Safety of Products of General Use ("Official Herald of RS", No. 92/11) shall cease to be valid.
Article 123
This Law shall enter into force on the eighth day from the date of its publication in the "Official Herald of the Republic of Serbia".