LAW FOR THE FOODSTUFFS
Prom. SG. 90/15 Oct 1999, amend. SG. 102/21 Nov 2003, amend. SG. 70/10 Aug 2004, amend. SG. 87/1 Nov 2005
Chapter one.
GENERAL PROVISIONS
Art. 1. (amend., SG 102/03) This law determines:
1. the requirement for the foodstuffs and their safety, packing, labelling and presentation;
2. the conditions and the order of production and trading foodstuffs;
3. the rights and obligations of the individuals who produce or trade foodstuffs;
4. the legal capacities of the state bodies for regulation and control of the production and trade of foodstuffs;
5. the functions and legal capacities of the professional organizations of the producers of foodstuffs and of the Bulgarian Association of food processing and beverage industry (BAFPBI) assigned to them by this law.
Art. 1a. (new, SG 102/03) The objective of the law is to provide the observance of the requirements for production and trade of foodstuffs in view of protecting the health and the interests of the consumers, prevention of activities regarding the foodstuffs, which may mislead the consumers, and creation of a possibility for the consumers to exercise their right to informed choice of foodstuffs offered on the market.
Art. 2. (1) In the context of this law food is every substance or product for human consumption regardless of whether it is processed, partially processed or not processed.
(2) (new, SG 102/03) Foodstuffs are also the beverages, the chewing gum and every substance, including water after its outflow from the water supply installations at the end consumer, used in the production of the food, preparation or processing, as well as the bottled mineral and table water.
(3) (prev. para 2 – amend., SG 102/03) No food in the meaning of this law are:
1. the animal food (fodder);
2. live animals;
3. plants before the crop gathering;
4. medicines, in the meaning of the Law of the medicines and pharmacies in the human medicine;
5. the narcotic and psychotropic substances in the meaning of the Law of the control over the narcotic substances and precursors;
6. the tobacco and tobacco products in the meaning of the Law of the tobacco and tobacco products;
7. wine and alcoholic beverages;
8. cosmetic products;
9. residues and pollutants;
10. not bottled natural mineral, spring and table water.
Chapter two.
REQUIREMENTS FOR THE FOODSTUFFS
Art. 3. (amend., SG 102/03) Offered on the market shall only be foodstuffs meeting the requirements of this law and having nutritious value not lower than the one generated by their approved composition, and which are safe for the human health.
Art. 4. (amend., SG 102/03) The specific requirements for groups of foodstuffs, for concrete foodstuffs and commodities imitating food shall be determined by ordinances of the Council of Ministers.
Art. 4a. (new, SG 102/03) (1) New foodstuffs or food components are those which have not been offered on the market for consumption by people, and which belong to one of the following categories of foodstuffs or food components:
1. containing or consisting of genetically modified organisms;
2. produced of genetically modified organisms without containing them;
3. of new or purposefully changes primary molecular structure;
4. consisting of or isolated from micro-organisms, mushrooms or duckweed;
5. consisting of or isolated from plants and animals which are not traditionally cultivated or raised as sources of food and have no history of safe using as food or food components;
6. produced by a production process not traditional for them, which leads to substantial changes in their contents or structure, whereas changes of their nutrition value occur, metabolism or the quantity of unwanted substances in them.
(2) The new foodstuffs and food components shall not:
1. pose a danger for the health of the consumer;
2. mislead the consumer;
3. differ from the foodstuffs and food components they are intended to replace regarding their nutrition value.
Art. 4b. (new, SG 102/03) (1) The Council of Ministers shall determine by an ordinance the requirements for the bottled natural mineral, spring and table waters for drinking, the conditions and the order of using the methods of processing the natural mineral and spring waters and for import of mineral water.
(2) The persons processing natural mineral and spring water for bottling shall inform the Minister of Health about the methods used in the processing and shall submit the necessary documents determined by the ordinance under para 1.
Art. 5. (1) (amend., SG 102/03) The Minister of Health, in coordination with the Minister of Agriculture and Forests shall approve by ordinances norms of maximum admissible quantities of various pollutants in the foodstuffs.
(2) Prohibited is the production and the trade of foodstuffs which contain pollutants above the norms determined by the order of para 1.
(3) (new, SG 102/03) Not permitted in the production of foodstuffs shall be the using of seeds for sowing when they have been treated by plant protection products.
Art. 6. (1) (amend., SG 102/03) The introduction of additives and aromatic products and the using of solvents and other auxiliary substances in the production of foodstuffs shall be admitted when:
1. (amend., SG 102/03) the necessity of using them for achieving definite technological effect is proven;
2. they do not present hazard for the health of the consumers in the quantities in which they are used;
3. (amend., SG 102/03) their using does not lead to misleading of the consumers regarding the type and the characteristics of the food.
(2) (amend., SG 102/03) The Minister of Health, in coordination with the Minister of Economy and with the Minister of Agriculture and Forests shall determine by ordinances:
1. (amend. and suppl., SG 102/03) the types of additives, aromatic products, solvents and other auxiliary substances which can be used in the production of foodstuffs and the admissible maximum concentrations for some of them in the ready made foodstuffs;
2. the specific criteria and requirements for purity of the additives and aromatic products designated for introduction in the foodstuffs;
3. (suppl., SG 102/03) the conditions and the order of permitting the using of solvents and other auxiliary substances, of new additives, as well as of the expansion of the range of application of already permitted additive;
4. the raw materials, the additives and the auxiliary substances for production, storing and using aromatic products;
5. (amend., SG 102/03) the information related to the additives and the aromatic products which must be marked on their packing, in the accompanying documentation and on the foodstuffs in which they are introduced;
6. the procedures of taking samples and the methods of analysis of the qualitative and quantitative proving of additives, aromatic products or their substances in or on the foodstuffs.
Art. 6a. (new, SG 102/03) (1) The additives to the foodstuffs shall be delivered to the consumers only pre-packed.
(2) The Minister of Health shall determine by an ordinance:
1. the requirements for the food additives;
2. the food substances (vitamins and minerals) which may be used in the production as food additives;
3. the criteria for purity of the food substances to be used as additives of the foodstuffs;
4. the information to be marked in labeling the additives to the foodstuffs.
Art. 6b. (new, SG 102/03) (1) Only groups of producers of foodstuffs who manufacture foodstuffs of traditionally specific nature shall file in the Ministry of Agriculture and Forests dossiers of the foods.
(2) The dossiers under para 1 shall include an application in a form approved by the Minister of Agriculture and Forests and specification of the foodstuff which shall contain the following data:
1. name of the foodstuff;
2. description of the method of production and of the characteristics of the used raw materials and components;
3. proof of the traditional nature of the raw materials, the traditional contents of the foodstuffs and/or the traditional method of production or processing;
4. the basic physical, chemical microbiological and organoleptic characteristics of the food expressing its specific nature;
5. the methods of checking up the characteristics under item 4.
(3) The names of the foodstuffs of traditionally specific nature must be traditional for the country or the region and must meet the requirements of Chapter Three.
(4) The Ministry of Agriculture and Forests may require from the applicants submission of additional data and documents and assist them in preparing the specifications.
(5) The Ministry of Agriculture and Forests shall keep a register of the filed dossiers of foodstuffs of traditionally specific nature, which shall contain the data under para 2. The information in the register under para 2, item 1, 4 and 5 shall be public.
(6) The order of accepting and completion of the dossiers of foodstuffs of traditionally specific nature and of keeping the register under para 5 shall be settled by an ordinance of the Minister of Agriculture and Forests.
Art. 6c. (new, SG 102/03) (1) The foodstuffs shall be considered biologically produced where the rules of biological production and the control over it have been complied with.
(2) The persons holding a certificate for biological production of foodstuffs may mark the foodstuffs by the words "biological" or "bio" on the foodstuffs or on information carriers accompanying them.
Chapter three.
REQUIREMENTS FOR THE PACKING, LABELLING AND ADVERTISEMENT OF THE FOODSTUFFS
Art. 7. (1) For the packing of foodstuffs and for contact with foodstuffs shall be used only materials and objects which:
1. (amend., SG 102/03) in storing and using according to the purpose and according to the approved requirements shall not release in the food components in quantities presenting hazard for the human health;
2. do not change the appearance, the smell, the taste and the composition of the food.
(2) The packing of the foodstuffs must not create possibilities of polluting the foodstuffs or the induction of substances alien and dangerous for the health of the consumer.
(3) The packing of the prepacked foodstuffs must be made in such a way not allowing change of the food.
Art. 8. (amend., SG 102/03) The Minister of Health and the Minister of Environment and waters shall determine by ordinances:
1. (amend. and suppl., SG 102/03) the list of substances which can be used for production of materials and objects for contact with foodstuffs, as well as the type of the materials themselves, the criteria for purity of the substances and the specific conditions for their using;
2. (amend., SG 102/03) the admissible levels of migration of components of materials or objects in or on the foodstuffs which they contact;
3. (amend., SG 102/03) the basic rules for exercising control over the materials and the contacting with foodstuffs, as well as the substances of which they are made;
4. (amend., SG 102/03) the way of indicating that the materials and the objects are designated for contact with foodstuffs, as well as the requirements for the necessary information on the packing or in the accompanying documentation.
Art. 9. (1) The producers and the sellers of foodstuffs shall be obliged to offer to the consumers in the country foodstuffs labelled in Bulgarian language.
(2) (amend., SG 102/03) Not admitted in the labelling of the foodstuffs shall be marking which impute or suggest qualities to the food related to prevention of the occurrence or treatment or diagnostics of diseases of people.
(3) (new, SG 102/03) The labeling, advertising and presentation of the foodstuffs, including their form, appearance, packing, packing material or object, way of commercial arrangement and the available information for them in the mass media shall not mislead the consumers regarding the characteristics of the foodstuffs determined by their nature, origin, identity, quality, contents, durability, method of production and using.
Art. 10. (1) In labelling the food shall be included data for the name by which the food is sold, the components of the food and their contents, the expiration term of the food and the conditions in which it must be stored, the net weight or volume, the headquarters and address of the producer, marking of the batch to which the food belongs and instructions for use if necessary.
(2) (amend., SG 102/03) The Minister of health, in coordination with the Minister of Agriculture and Forests shall determine by an ordinance the conditions and the requirements for the presentation of the nutrition information in labelling the foodstuffs.
(3) The Council of Ministers shall adopt by an act the requirements for the labelling and presentation of the foodstuffs.
Art. 11. (revoked, SG 102/03)
Chapter four.
PRODUCTION AND TRADE OF FOODSTUFFS
Art. 12. (amend., SG 102/03) (1) Production and trade of foodstuffs shall be carried out by entrepreneurs and craftsmen only in sites registered by the order of this law and if the following requirements are met:
1. every site shall meet the sanitary and/or veterinary sanitary requirements determined by the special laws;
2. there shall be a technological documentation for the groups of foodstuffs to be produced on the site;
3. there shall be an implemented system of self control of the production or trading activity to be carried out on the site.
(2) (amend. SG 87/05) The registration of a site for production or trade of foodstuffs shall be made by the Regional Inspectorate for Preservation and Control of Public Health (RIPCPH), respectively by the Regional Veterinary Office (RVO) at the location of the site. The RIPCPH shall make a registration of the sites for production and wholesale trade of foodstuffs of non-animal origin as well as of the sites for retail trade with foodstuffs, with exception of the sites for retail trade where only foods of animal origin are offered. The regional veterinary office shall register the sites for obtaining, production, processing, storing, packing and re-packing of raw materials and foodstuffs of animal origin, of the sites of wholesale trade of foodstuffs of animal origin as well as the sites for retail trade where only foods of animal origin are offered.
(3) In order to register the persons under para 1 shall file an application in a form, stating the name and address of the person, respectively seat, address of management, tax number and BULSTAT code, as well as address of the site. Attached to the application shall be:
1. a certificate for current status of the applicant where it is subject to issuance;
2. a permit for using the site issued by the order of the Law of the spatial planning;
3. a permit for assessment of the impact on the environment issued by the order of the Law of protection of the environment where such is required;
4. a list of the groups of foodstuffs or meals to be produced or sold on the site.
(4) For incompleteness of the presented documents under para 2 within 10 days from filing the application the respective body shall inform in writing the person about that and shall determine the deadline for its rectification.
(5) (suppl. SG 87/05) Within 30 days from filing the documents under para 3 or removal of the incompleteness under para 4 the respective body shall carry out an inspection on the spot for compliance of the site with the requirements under para 1. For established non-compliance with the requirements the body shall prescribe and determine an appropriate period for bringing in compliance.
(6) (new – SG 87/05) Representative of the respective RVO shall also participate in the check on the spot of para 5 for sites of retail trade where foods of animal origin are offered, subject to registration in RIPCPH.
(7) (prev. (6) – SG 87/05) Within 15 days after the inspection, or after bringing in compliance, according to the prescription under para 5, the respective body shall make registration of the site.
(8) (prev. (7), amend. SG 87/05) Within 7 days from the registration under para 7 the respective director of RHEI or of RVO shall issue a certificate for registration.
Art. 13. (amend., SG 102/03) (1) For failure to rectify incompleteness of the filed documents under Art. 12, para 4 and/or for non-fulfilment of a prescription under art. 12, para 5 the body under art. 12, para 2 shall make a motivated refusal of registration and shall inform the applicant for that.
(2) If no decision is announced by the body under art. 12, para 2, considered shall be a presence of a tacit assent and art. 28 and 29 of the Law of restriction of the administrative regulation and administrative control over the economic activity shall apply respectively. The applicant shall have the right to carry out production or trading on the site upon preliminary written notification about that to the respective body, and where it does not announce an explicit refusal within 7 days from receipt of the notification.
(3) In the cases of tacit assent the respective body shall be obliged to make the entry in the register under art. 14, para 1 within 14 days from the written notification under para 2, unless he has announced a refusal under para 1 or 2.
Art. 14. (amend., SG 102/03) (1) The RHEI, respectively RVO, shall keep a regional register of the sites for production and trade with foodstuffs according to their competence under art. 12, para 2, containing:
1. the number and the date of issuance of the certificate of the registered site;
2. data for the site;
3. type of the site (for production or trade);
4. groups of foodstuffs produced or offered on the registered site;
5. veterinary registration number of the sites entered in the register of RHEI;
6. the company name or the name of the person carrying out activity of production or trade on the site;
7. date of deletion of the registration and the grounds for that;
(2) The Regional Hygiene and Epidemiological Inspection shall notify in writing, within 7 days, the respective RVO about the registrations made by it of sites of trading foods of animal origin.
(3) On the grounds of the registers all RHEI and RVO of the Ministry of Health, respectively of the Ministry of Agriculture and Forests, shall maintain national registers of the sites for production and trading of foodstuffs, which shall be computerized. The national registers of the sites for production and trading of foodstuffs shall be public and theyr shall be published in Internet.
Art. 15. (amend., SG 102/03) For change of the circumstances subject to entry under Art. 14, para 1 the respective change shall be entered in the register and in the issued certificate.
Art. 16. (amend., SG 102/03) (1) The validity of the registration and of the certificate shall be termless.
(2) The registration shall be written off and the certificate shall be nullified by an order of the Director of RHEI, respectively of RVO:
1. for termination of the activity at a request of the person carrying out the production or trade on the site;