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Law No. 150 Of 14 May 2004 On Food Safety

Original Language Title:  LEGE nr. 150 din 14 mai 2004 privind siguranţa alimentelor

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LEGE no. 150 150 of 14 May 2004 (* republished *) on food and feed safety *)
ISSUER PARLIAMENT
Published in OFFICIAL MONITOR no. 959 959 of 29 November 2006



_____________ Note * *) Republicated pursuant to art. II of Law no. 412/2004 to amend and supplement Law no. 150/2004 on food safety, published in the Official Gazette of Romania, Part I, no. 990 of 27 October 2004, giving the texts a new numbering. Law no. 150/2004 was published in the Official Gazette of Romania, Part I, no. 462 462 of 24 May 2004. + Chapter I General provisions + Article 1 (1) This law is the basis for ensuring a high level of protection of public health and consumer interests with regard to food, taking into account the diversity of food sources, ensuring the effective functioning of national market. (2) The present law establishes common principles and responsibilities, the means to ensure a sound scientific basis, effective organizational requirements and procedures to support the making of the most suitable decisions in the field of food safety and of animal feed. (3) For the purposes provided in par. ((1), this law lays down the general principles applicable to food and feed in general and to their safety in particular. (4) This law establishes procedures with regard to problems which have a direct or indirect impact on the safety of food and feed. (5) The provisions of this Law shall apply to all stages of production, processing, distribution and placing on the market of food and feed, except for primary production for private household use or preparation, handling or storage foods intended for private household consumption. + Article 2 The National Veterinary Health and Food Safety Authority, established by Government Ordinance no. 42/2004 on the organization of veterinary and food safety activity, approved with amendments and additions by Law no. 215/2004 , with subsequent amendments and completions, hereinafter referred to as the Authority, is the regulatory authority in the veterinary field and for food safety, which coordinates all activities in this field, from the production raw materials to the consumer. The Authority shall be the liaison institution with the European Food Safety Authority and shall act on the basis of structural, functional and decision-making autonomy. + Article 3 (1) For the purposes of this law, food or foodstuff means any product or substance, whether wholly or partially processed, intended for human consumption or intended for human consumption. (. Food shall also include beverages, chewing gum and any other substance, including water, intentionally incorporated into food during the production, preparation or treatment of it. (. The concept of food shall not include: a) feed; b) live animals, unless they are intended to be processed for the placing on the market of products intended for human consumption; c) plants before harvest; d) medicinal products; e) cosmetic products; f) tobacco and tobacco products; g) narcotic and psychotropic substances; h) residues and contaminants. + Article 4 Within the meaning of the present law, the following terms are defined as a) legislation in the field of food-laws, other normative acts, as well as administrative provisions governing food, in general, and food safety, in particular, including residues and contaminants present in food and food for animals, and shall apply at all stages of the production, processing and distribution of food, as well as feed, produced or used for food producing animals; b) food activity-any activity correlated with one of the stages of food production, processing and distribution; c) food business-any establishment, whether or not it has the purpose of obtaining profit and whether it is public or private, which carries out any of the activities related to one of the stages of production, food processing and distribution; d) operator with activity in the food field-natural person or legal person responsible for meeting the requirements of food law in the food company under its control; e) feed-any substance or product, including additives, wholly or partially processed, intended to be used for animal feeding; f) enterprise having as animal feed profile-any establishment, whether or not it has the purpose of obtaining profit and whether it is public or private, which carries out any of the activities related to one of the stages of production, manufacture, processing, storage, transport or distribution of feed, including any producer producing, processing or storing feed for the feed of the animals of his or her own holding; g) animal feed activity-any activity of production, processing, storage, transport or distribution of feed, including the activity of any agricultural producer producing, processing or storing food for animals intended for animals of their own holding; h) operator with activity in the field of animal feed-natural person or legal person responsible for meeting the requirements of food law in the enterprise having as animal feed profile, under the control i) retail trade-the handling and/or processing of food and their storage at the points of sale or delivery to the final consumer, including distribution terminals, catering operations, canteens of factories, units of catering, restaurants and other similar operations in the field of food services, shops, supermarket distribution centres and wholesale markets; j) placing on the market-possession of food or feed for sale, including offering for sale or any other form of transfer, free of charge or not, and the sale, distribution and other forms of transfer; k) risk-the likelihood of a harmful effect for health, as well as the severity of this effect, as a result of exposure to a hazard; l) risk analysis-the process consisting of 3 interrelated components: risk assessment, risk management and risk communication; m) risk assessment-scientific process consisting of 4 stages, namely: identification of danger (hazard), characterization of danger (hazard), exposure assessment and risk characterization; n) risk management-process, distinct from risk assessment, consisting of the appreciation of different alternative policies, in consultation with stakeholders, taking into account risk assessment and other possible factors and, if required, selection adequate prevention and control options; o) communication of risk-interactive exchange of information and opinions, during the course of risk analysis, on hazards and risks, risk factors and risk perception, risk managers, risk managers, consumers, food-business enterprises, enterprises with a feed profile, the academic community and other stakeholders, including the explanation of the results of the risk assessment and the basis of risk management decisions; p) danger-a biological, chemical or physical agent or a state thereof, present in food or feed, with the potential to cause a harmful effect for health; q) traceability-the possibility of identifying and tracing, during all stages of production, processing and distribution of a food, feed, animal intended for the production of food or a substance which is to be incorporated or which can be incorporated into a food or feed; r) stages of production, processing and distribution-any stage, including import, from and including primary food production to and including storage, transport, sale or supply to the final consumer and, where applicable, import, manufacture, manufacture, storage, transport, distribution, sale and supply of feed; s) primary production-production, animal husbandry or plant cultivation, as primary products, including harvesting of production from them, milking and production resulting from animals before cutting. Primary production also includes hunting and fishing, as well as the collection of products from animals and wild plants; s) the final consumer-the latter consumer of food products that does not use the food as part of an operation or activity in the field of activity of a food company. + Chapter II General food law + Section 1 Scope of application + Article 5 (1) The provisions of the food law shall apply at all stages of the production, processing and distribution of food and feed, intended for or administered to animals for the production of foodstuffs. (2) The general principles provided for in art. 6-11 form the general framework to be followed when action is taken. (3) The principles and procedures in force on food law will be adapted as soon as possible, but not later than 1 January 2007, in order to comply with the principles laid down in art. 6-11. (4) Until January 1, 2007 and by exception to the provisions of par. (2), the legislation in force shall apply, and shall adapt to the principles provided for in art. 6-11. (5) Based on this law, the Authority, in collaboration with the competent institutions according to the law, will develop the specific legislation in the field of food and feed safety. + Section 2 General objectives + Article 6 (1) Food legislation pursues one or more general objectives on a high level of protection of human life and health, consumer interests, including fair practices in the food trade, taking into account, then where appropriate, the protection of the health and welfare of animals, the health of plants and the environment. ((2) Food legislation aims to achieve the free movement of food and feed, manufactured or placed on the market in accordance with the general principles and requirements laid down in this Chapter. (3) In the development or adaptation of food law, existing international standards or at the stage of being adopted shall be taken into account, except where such standards or relevant parts thereof would be ineffective or inadequate means for achieving the objectives of food law or when there is scientific justification or where they may determine a level of protection different from that established as appropriate to community level. + Article 7 (1) In order to achieve the general objective aimed at ensuring a high level of protection of people's health and life, food law is based on risk analysis, unless this approach is not appropriate circumstances or nature of the measure. (. The risk assessment shall be based on the available scientific information and shall be carried out independently, objectively and transparently. (3) Risk management takes into account the results of the risk assessment and other relevant factors for risk management and the precautionary principle, in order to achieve the general food law objectives set out in art. 6. + Article 8 ((. In specific cases where, following the evaluation of existing information, the possibility of harmful effects on health is identified, but a scientific uncertainty subsists, interim risk management measures may be adopted, necessary to ensure a high level of health protection, pending the collection of other scientific information with a view to a more complete risk assessment. (2) The measures adopted under the provisions of par. ((1) will be proportionate to the possible effects of the risk and will not restrict food trade more than is necessary to ensure a high level of health protection, taking into account technical and economic possibilities and of other relevant factors. (3) Measures adopted on the basis of paragraph (1) are reviewed within a reasonable period, which depends on the nature of the risk identified for life or health, as well as the type of scientific information necessary to clarify scientific uncertainty and to achieve a more complete risk assessments. + Article 9 Food law aims to protect the interests of consumers and to provide them with the necessary information, in order to choose in the knowledge of the food they eat, and aims to prevent: a) fraudulent or deceptive practices; b) falsification of food; c) any practices that may mislead the consumer. + Section 3 Transparency principles + Article 10 The development, evaluation and modification of food law must be carried out in an open and transparent process of public consultation, directly or through the Authority, the Ministry of Public Health, the Authority National for Consumer Protection, Ministry of Agriculture, Forestry and Rural Development, other authorities involved in the field, as well as institutions represented in the Authority's Advisory Council, except in cases which the urgency of the settlement does not allow this action. + Article 11 Without prejudice to the provisions applicable by national legislation on access to documents, where there are reasonable grounds for suspecting that food or feed may pose a risk to the health of consumers, or The Authority shall take the necessary measures, together with the other competent authorities in the field of food safety, where appropriate, depending on the nature, gravity and extent of that risk, to inform the general public of the nature of the nature of the the health risk, identifying as exactly as food or food for animals or the type of food or feed involved, the risk they pose, and the measures taken or are intended to be taken to reduce or eliminate that risk. + Section 4 General obligations on trade in foodstuffs + Article 12 Food and feed, imported for placing on the market in Romania, must comply with the requirements of food law or those provided for by the agreements concluded between Romania and the exporting country. + Article 13 (1) Food and feed, intended for export or re-export for placing on the market in a third country, must comply with the relevant food law requirements unless otherwise provided. by the competent authority of the importing country or established by legislation, regulations, standards, codes of practice and other legal and administrative procedures in force in the importing country. (2) In other situations, unless food is harmful to health or feed is not safe, they may be exported or re-exported only if the competent authority of the country of destination has been of express agreement, after having benefited from all the information regarding the reasons and situations for which food or feed was not put on the market in Romania. ((3) If the provisions of a bilateral agreement between Romania and a third country are applied, food and feed, exported from Romania, must comply with the said provisions. + Article 14 In the field of food trade, the Authority shall, together with the other competent authorities in the field of food safety, where appropriate, the following obligations: a) contribute to the development of technical rules for food and feed and the development of food safety standards; b) promote and coordinate activities on food and feed standards developed by international governmental and non-governmental organisations; c) contribute, if necessary, to the development, approval and promotion of agreements on the recognition of the equivalence of specific measures on food and feed; d) pay particular attention to the particular development, financial and commercial needs of developing countries, to ensure that international rules do not create unnecessary obstacles to the achievement of exports from these countries; e) to promote the consistency between international technical standards and legislation in the field of food, so that the high level of protection is not diminished. + Section 5-a General requirements of food law + Article 15 The following requirements must be complied with in order to achieve a) food should not be placed on the market if it is not safe b) food is considered unsafe if it is harmful to health or unfit for human consumption; c) to determine whether a food is unsafe will take into account the normal conditions of use of food by the consumer at each stage of production, processing and distribution, and the information provided to the consumer, including information on the label or other general information made available to the consumer, on the avoidance of specific health-related effects caused by a particular food or food category; d) to determine whether a food is harmful to health should be considered not only the immediate and/or short-term probable and/or long-term effects of that food on the health of the person consuming it, but also the effects on future generations, possible cumulative toxic effects, and particular sensitivity to the health of a specific category of consumers when food is intended for that category of consumers; e) to determine whether a food is improper for human consumption should be considered if the food is unacceptable for human consumption in accordance with its intended use, for reasons of contamination caused by factors external or not, of alteration, deterioration or degradation; f) where an unsafe food is part of a consignment, sarge or consignment of food of the same class or with the same description, it is assumed that all food of that lot, sarge or consignment is also unsafe, outside where, following a detailed assessment, there is no evidence to indicate that the rest of the consignment, the sarge or the consignment is unsafe; g) food which satisfies the specific legislative provisions governing food safety shall be deemed not to be a risk in respect of the matters covered by that legislation; h) the conformity of a food with the specific provisions applicable to that food will not prevent the Authority, together with the other competent authorities in the field of food safety, where appropriate, take appropriate measures to impose restrictions on its placing on the market or require its withdrawal from the market, where there are grounds for suspecting that, despite such compliance, the food is unsafe. + Article 16 The feed safety requirements are: a) feed shall not be placed on the market or used in feedingstuffs intended for food production unless it is safe; b) feed is considered unsafe for the purpose of its use, if it is estimated to have a harmful effect for the health of humans or animals or makes food derived from animals intended for food production become unsafe for human consumption; c) where food for animals which has been identified as not satisfied with the animal feed safety requirements is part of a consignment, sarge or transport of feed from the same class or with the same description, assumes that all feed in the lot, sarge or transport is affected, unless, following the completion of a detailed assessment, there is no evidence that the rest of the lot, the sarge or the consignment does not meet the requirements of the safety of feed; d) feed which complies with the specific legislation governing the safety of feed shall be deemed to be safe in respect of the matters covered by that legislation; e) the compliance of the feed with the specific provisions applicable to it shall not prevent the Authority, together with the other competent authorities in the field of food safety, where appropriate, take appropriate measures to impose restrictions on its placing on the market or to require its withdrawal from the market, where there are grounds for suspecting that, despite such compliance, feed is unsafe. + Article 17 Without prejudice to the specific provisions of food law, labelling, advertising and presentation of food and feed including its shape, appearance or packaging, the materials used for packing, the manner of presentation and the framework in which they are disposed, as well as the information disseminated by any means, must not mislead the consumer. + Article 18 ((1) Operators with activity in the food field and those with activity in the field of animal feed must take the necessary measures for food and feed to meet the requirements of food and food law for animals, which is relevant to their activities, to verify that these requirements are achieved and to ensure the implementation of the food safety management system according to the principles of risk analysis and points critical control (Hazard Analysis and Critical Control Point-HACCP) at all stages production, processing and distribution, within the business under its own control. (2) The Authority must ensure the application of food law. It coordinates the work of the competent authorities in the field of food safety, controls and verifies compliance with food law by food business operators and those with activity in the field of feed, as well as the implementation of the food safety management system according to the principles of risk analysis and critical control points (Hazard Analysis and Critical Control Point-HACCP), at all stages production, processing and distribution. To that end, the Authority must maintain a control system and other activities necessary according to the situation, including public communication activities with regard to the safety and risk of food and feed, surveillance of the safety of food and feed and other monitoring activities covering all stages of production, processing and distribution. (3) The measures and sanctions that apply to the violation of the provisions of the legislation on food and feed shall be established under the law. Measures and sanctions must be effective, proportionate and dissuasive. + Article 19 ((1) The traceability of food, feed, animals intended for the production of food and any other substances intended to be intended for incorporation into food or feed must be established in all stages of production, processing and distribution. ((2) Operators with activity in the field of food and those with activity in the field of animal feed must be able to identify any person from whom they have procured food, feed, animals intended for production of food or any substance intended or intended to be incorporated into food or feed. To that end, such operators must have systems and procedures in place to enable the information to be made available to the Authority at the request of the Authority. ((3) Operators with activity in the food field and those with an activity in the field of feed must have systems and procedures in place to identify other activities to which their products are intended. This information will be made available to the Authority at its request. (4) Food or feed, which is placed on the market or which are suitable for placing on the market, must be labelled or adequately identified in order to facilitate their traceability, by means of documentation or relevant information, in accordance with the requirements and specific provisions. + Article 20 (1) Where a food business operator considers or has reason to believe that a food which it has imported, produced, processed, manufactured or distributed is not in accordance with food safety requirements, it shall be immediately initiate the procedures for withdrawal of that food from the market if it is no longer under the direct control of that operator with activity in the food field and shall inform the Authority thereof. If the product has reached the consumer, it must be informed effectively and precisely by the operator of the reason for the withdrawal of the food on the market and, if necessary, the operator will take over from it the food already provided, where other measures are not sufficient to ensure a high level of health protection. ((2) Any food business operator responsible for retail or distribution activities shall initiate the procedures for the withdrawal of products which are not in conformity with the requirements of food safety on the market, within the limits of their own activity, and shall provide information in order to ensure their traceability by participating in the actions undertaken by the producers, processors and/or the Authority. ((3) Any food business operator shall immediately inform the Authority if it considers or has reason to believe that a food which it has placed on the market may be harmful to human health. Operators must inform the Authority of the measures taken to prevent risks to the final consumer and will not prevent or deter any person from cooperating with the Authority, in accordance with national law and legal practices, where this action may result in the prevention, reduction or elimination of a risk caused by a food. ((4) The food business operators must work with the Authority on the actions taken to avoid or reduce the risk caused by the food they provide or have provided. + Article 21 ((. Where an operator with an activity in the field of animal feed considers or has reason to believe that food for imported, produced, processed, manufactured or distributed animals does not satisfy the food safety requirements for animals, it will immediately initiate the procedures for the withdrawal of the food in question from the market and inform the Authority about it. In this situation or in the situation provided for in art. 16 lit. c) where the consignment, the sarge or the consignment does not satisfy the animal feed safety requirements, it must be destroyed unless otherwise decided by the Authority. The operator must inform effectively and exactly the users of the feed of the reason for its withdrawal and, if necessary, recover from them the products already supplied, when other measures are not sufficient to achieve a high level of health protection. ((2) Any operator with activity in the field of animal feed, responsible for retail or distribution activities, shall initiate the procedures for the withdrawal from the market of products which are not in conformity with the requirements of animal feed safety, within the limits of its own activity, and will provide information in order to ensure their traceability, participating in the actions taken by producers, processors and/or the Authority, together with the others competent authorities in the field of food safety, where appropriate. ((3) Any operator with an activity in the field of animal feed shall immediately inform the Authority if it considers or has reason to believe that the animal feed it has placed on the market may not satisfy the food safety requirements. for animals. Operators must inform the Authority of the measures taken to prevent the risks deriving from the use of that animal feed and will not prevent or deter any person from cooperating with the Authority, in accordance with national legislation and legal practices, where this action may result in the prevention, reduction or elimination of a risk resulting from that feed. ((4) Operators with an activity in the field of animal feed must collaborate with the Authority in respect of actions taken to avoid or reduce the animal feed risks they provide or have Supplied it. + Article 22 Food and feed safety liability lies with agents and operators in the food and feed industry. + Article 23 (1) The Authority will coordinate the rapid alert system, crisis management and emergency situations in the field of food and feed safety. (2) The Authority will approve, together with the Ministry of Public Health, the National Authority for Consumer Protection and the Ministry of Agriculture, Forestry and Rural Development, by joint order, technical norms for the implementation of provisions of para. ((1). (3) The Authority, the national coordinator of the rapid alert system in the field of food and animal feed, is the point of contact with the rapid alert system for food and feed at European level (Rapid Alert System for Food and FeedRASFF). + Article 24 By order of the President of the Authority or, as the case may be, by joint order with the other institutions empowered according to the law, according to the field of competence, specific rules for the application of this law will + Section 6 Final provisions + Article 25 This law shall enter into force 30 days after its publication in the Official Gazette of Romania, Part I. -------