Plant Protection Act

Promulgated SG. 91/10.10.1997, amended, SG. 90/15.10.1999, amended and supplemented, SG. 96/9.11.2001, supplemented, SG. 18/5.03.2004, effective 6.04.2004, amended and suppleme nted, SG No. 26/28.03.2006, effective 28.03.2006, amended, SG No. 31/14.04.2006, effective 14. 04.2006, amended, SG No. 96/28.11.2006, effective 1.01.2007, amended and supplemented, SG No. 13/8.02.2008, effective 31.01.2008, amended, SG No. 36/4.04.2008, SG No. 43/29.04.2008, SG No. 82/16.10.2009, effective 16.10.2009, amended and supplemented, SG No 8/25.01.2011, e ffective 25.01.2011, SG No. 28/5.04.2011, effective 5.04.2011

Chapter One GENERAL PROVISIONS

Article 1. (Amended and supplemented, SG No. 96/2001, supplemented, SG No. 26/2006, a mended, SG No. 28/2011, effective 5.04.2011) This Act shall regulate:

1. the phytosanitary measures under the International Plant Protection Convention and the co nduct of phytosanitary control of plants and plant products;

2. the implementation and the improvement of methods of integrated pest control for plants and plant products;

3. the requirements for plant protection products and fertilisers, the procedures for testing, p ermitting, production control, repackaging, storage and placing on the market and their use with a view to protecting human and animal health and the environment;

4. the requirements for the phyto-sanitary quality and the control of plants and plant product s intended for the home market and for export;

5. the control of the compliance of plant protection products with the characteristics approve d at the time of granting a permit;

6. the requirements for storing the documentation on the quantities of plant protection produ cts and fertilizers placed on the market and used;

7. the measures for implementation of Regulation (EC) No. 2003/2003 of the European Parli ament and the Council of 13 October 2003 relating to fertilizers, hereinafter referred to as `Regul ation (EC) No. 2003/2003';

8. the control of pollutants in the plant raw materials; 9. the control over the integrated production of plants and plant products;

10. requirements and organisation of observation, examination and diagnostics of economica lly important agricultural pests.

Article 2. (1) (Amended, SG No. 96/2001; supplemented, SG No. 18/2004, amended, SG N o. 8/2011, effective 25.01.2011) The Ministry of Agriculture and Food, via the Bulgarian Food S afety Agency, shall discharge the control, diagnostic, research, applied science and management f unctions vested under this Act.

(2) (Repealed, SG No. 8/2011, effective 25.01.2011).

(3) (Repealed, SG No. 8/2011, effective 25.01.2011).

(4) (Repealed, SG No. 96/2001).

Article 3. (Amended, SG No. 96/2001, amended, SG No. 8/2011, effective 25.01.2011) For the performance of activities under this Act, fees shall be collected as per the tariff under Article 3(4) of the Bulgarian Food Safety Agency Act.

Article 4.(Amended, SG No. 90/1999, repealed, SG No. 8/2011, effective 25.01.2011). Chapter Two CONTROL ON THE TERRITORY OF THE COUNTRY Section I Protection against pests and phyto-sanitary control (Title amended, SG No. 96/2001)

Article 5. (1) The import, storage or transportation of quarantine pests on the territory of the Republic of Bulgaria shall be prohibited, regardless of the stage of their development.

(2) (Repealed, SG No. 96/2001).

Article 6. The Minister of Agriculture and Food, upon a proposal made by the Bulgarian Fo od Safety Agency, shall:

1. approve a list of pests, plants and plant products or of other pest vectors;

2. determine the specific conditions for pest control;

3. (supplemented, SG No. 96/2001, amended, SG No. 26/2006, effective 28.03.2006) in case s of established disease caused by quarantine and pests, order the quarantine, disinfection, disinse ction, fumigation or other chemical treatment, order prohibition of planting or consumption, exter mination by incineration or another method of extermination of plants, parts of plants or other ve ctors in a specific region, in its adjacent areas or buildings, warehouses and vehicles, or return of the imported commodities to the exporting country.

Article 7. The Ministry of Agriculture and Food shall:

1. determine obligatory conditions for transportation on the territory of the country of plants, plant products, equipment, soil, manure, compost and nutrients, as well as containers and other fa cilities which are or may be carrying or spreading pest-caused diseases;

2. provide and circulate special information regarding the plant and plant product pests;

3. (amended, SG No. 96/2001) organise the observation, diagnostics, prognosis and signalisa tion for pests control under terms and procedure determined with a regulation issued by the Minis ter of Agriculture and Food.

Article 8. (1) All plants and plant products shall be kept and stored in good phyto-sanitary c ondition by the persons who grow, produce, store, transport and sell them.

(2) In cases of violations under Paragraph 1 the control bodies of the Bulgarian Food Safety Agency shall issue obligatory prescriptions for their elimination.

(3) (New, SG No. 28/2011, effective 5.04.2011) The individual administrative acts referred t o in paragraph 2 may be appealed against before the Director of the respective Regional Food Saf ety Agency according to the procedure laid down in the Code of Administrative Procedure. The a ppeal shall not suspend the enforcement.

(4) (New, SG No. 96/2001, renumbered from Paragraph 3, SG No. 28/2011, effective 5.04.2 011) The persons producing or trading in plant products shall keep a log of the conducted chemic al treatment for each field or store according to a sample approved by the Minister of Agriculture and Food.

(5) (New, SG No. 28/2011, effective 5.04.2011) The persons referred to in paragraph 1 shall keep the documentation on the types and quantities of plant protection products and fertilizers use d by crop and area and shall provide data upon request from the Bulgarian Food Safety Agency a ccording to a model approved by the agency's Executive Director.

Article 8a. (New, SG No. 26/2006, effective 28.03.2006) (1) (Supplemented, SG No. 28/20 11, effective 5.04.2011) Protection of plants and plant products from economically important pest s shall take place in conformity with the principles of Good plant protection practice by individua l crops or the principles of integrated production.

(2) The terms and procedure for integrated production of plants and plant products and for th eir marking, shall be determined by Ordinance of the Minister of Agriculture and Food.

Article 8b. (New, SG No. 26/2006, effective 28.03.2006) (1) (Amended, SG No. 8/2011, eff ective 25.01.2011) When discharging their official duties, the control bodies of the Bulgarian Foo d Safety Agency shall identify themselves by means of office identity cards and the phytosanitary inspectors working at the border inspection phytosanitary points (BIPSP) shall also wear uniform s.

(2) (Amended, SG No. 8/2011, effective 25.01.2011) The type of used uniform and office id entity card under Article 1 shall be determined by rules approved by the Minister of Agriculture a nd Food.

Article 9. Any legal or natural person who establishes the presence of an unknown pest shall be obliged to inform immediately the competent state authorities thereof.

Article 10. In performing their official duties the control bodies of the Bulgarian Food Safet y Agency shall have the right to:

1. enter customs, customs offices, duty free zones, located in sea and river ports, airports, rai lway and bus stations, postal offices, warehouses and their depositories, all trains, vessels, civil a viation planes and vehicles entering the country for examination of quarantine materials of plant origin carried by them;

2. visit and examine crops and plants, nurseries, uterine beds, greenhouses, botanical garden s, experimental grounds of institutes and stations, firms, tenant farmers, agricultural cooperatives, personal farms, warehouses and refrigeration premises, processing plants, shops and markets.

3. (New, SG No. 28/2011, effective 5.04.2011) inspect the sites where plant protection prod ucts, fertilizers, soil improvers, biologically active substances and nutrient substrates are produce d, packaged, repackaged, stored and placed on the market in compliance with Sections IV and V of this Chapter.

4. (New, SG No. 28/2011, effective 5.04.2011) demand assistance from the units of the Mini stry of Interior.

Article 11. (Amended, SG No. 96/2001) (1)The Bulgarian Food Safety Agency shall exprop riate in favour of the state plants and plant products where:

1. the prohibition referred to in Article 5 has been violated;

2. the requirements referred to in Articles 27 and 35 have not been observed;

3. the batch has been contaminated with quarantine pests and cannot be rehabilitated;

4. they are offered on the market without a phyto-sanitary passport.

(2) The destruction of plants and plant products shall be carried out following a procedure an d method determined with a methodology approved by the Minister of Agriculture and Food.

Article 12. (1) Subject to phyto-sanitary control shall be: 1. plants, including seeds;

2. (amended, SG No. 96/2001) plant products;

3. nutrients, vehicles and packaging of and from plants and plant products.

(2) (Amended, SG No. 96/2001, supplemented, SG No. 28/2011, effective 5.04.2011) Phyt o-sanitary control shall be conducted in the form of checks carried out by phytosanitary inspector s from the Bulgarian Food Safety Agency.

(3) (Amended, SG No. 96/2001) All persons producing or importing plants and plant produc ts with a scientific or commercial purpose, as well as the public warehouses and markets places s hall be obliged to register at the respective regional food safety directorate under terms and proce dure determined in a regulation issued by the Minister of Agriculture and Food.

(4) (Amended, SG No. 96/2001) A phyto-sanitary passport conforming with a sample shall b e issued to each batch of plants and plant products.

(5) (Amended, SG No. 96/2001) No fees shall be due for the registration referred to in Parag raph 3.

(6) (Repealed, SG No. 96/2001).

Article 12a. (New, SG No. 96/2001, repealed, SG No. 96/2006, effective 1.01.2007).

Article 13. (Amended, SG No. 28/2011, effective 5.04.2011) Where the presence of quarant ine pests is established in the seed production and other sectors and sites, the bodies of the Bulgar ian Food Safety Agency shall order treatment and quarantine until the complete disinfection or ex termination. The owner or the user shall be obliged to comply with the prescriptions issued by the competent state authorities. Section II Control for chemical pollutants (Repealed, new - SG No. 96/2001, title amended, SG No. 28/2 011, effective 5.04.2011)

Article 13a. (1) (Amended, SG No. 8/2011, effective 25.01.2011, SG No. 28/2011, effective 5.04.2011) The Bulgarian Food Safety Agency shall monitor the raw materials and foods of plant origin for content of chemical pollutants pursuant to the Foodstuffs Act.

(2) The monitoring referred to in Paragraph 1 shall be performed systematically or upon a si gnal about pollution during the vegetation, production, storage and/or trade with plant raw materi als.

(3) (Amended, SG No. 82/2009, SG No. 8/2011, SG No. 28/2011, effective 5.04.2011) The monitoring referred to in Paragraph 1 shall comprise inspections, the documentation checks and t aking of average samples for analysis. The samples shall be analysed in laboratories determined b y the Minister of Agriculture and Food and accredited by a national accreditation body of an EU member state.

Article 13b. (1) (Previous text of Article 13b, amended, SG No. 26/2006, repealed, SG No. 28/2011, effective 5.04.2011) . Section III Control of the quality and correspondence of fresh fruit and vegetables (New, SG No. 96/2001) Control for chemical and biological pollutants

Article 13c. (Repealed, SG No. 31/2006, effective 14.04.2006). Section IV (Previous section III - SG No. 96/2001) Plant protection products, biologic agents and active substan ces

Article 14. (Amended, SG No. 96/2001, No. 26/2006, effective 28.03.2006) (1) (Amended, SG No. 8/2011, effective 25.01.2011, SG No. 28/2011, effective 5.04.2011) Plant protection prod uct placed on the market and their usage shall be determined with an order issued by the executiv e director of the Bulgarian Food Safety Agency.

(2) (Amended, SG No. 8/2011, effective 25.01.2011) Based on the order under paragraph (1), the executive director of the Bulgarian Food Safety Agency or an official authorised by the e xecutive director shall issue ex-officio to the applicant a certificate of authorization for each indiv idual plant protection product, the content of which shall be determined by the Ordinance under p aragraph (5).

(3) A non-permitted plant protection product may be produced, stored and transported in the country, if it is intended for use in another country, where it has been approved for use.

(4) The terms and procedure, according to which production, storage and transportation of u nauthorized plant protection products under paragraph (3), may take place in accordance with the Ordinance under Article 23c.

(5) The procedure for authorization of plant protection products shall be determined by Ordi nance of the Council of Ministers. (6). (New, SG No. 28/2011, effective 5.04.2011) The holder of the certificate of authorizatio n referred to in paragraph 2 shall submit annual declarations reporting the quantities of products p laced on the market according to a model approved by the Executive Director of the Bulgarian Fo od Safety Agency.

Article 14a. (New, SG No. 26/2006, effective 1.01.2008) (1) Upon proposal by the applican t or when assigned by the European Commission, the Bulgarian Food Safety Agency shall make an evaluation and draw up a report for inclusion of an active substance in the list of active substa nces, permitted in the European Union.

(2) The terms and procedure for making the evaluation and for drawing up the report under paragraph (1) shall be determined by Ordinance of the Council of Ministers.

(3) A fee shall be payable for the evaluation under paragraph (1) according to the tariff unde r Article 3.

Article 15. (Amended, SG No. 96/2001, No. 26/2006, effective 28.03.2006) (1) (Amended, SG No. 8/2011, effective 25.01.2011) The executive director of the Bulgarian Food Safety Agenc y shall approve by order a list of:

1. active substances, authorized in the European Union;

2. the active substances, in regard to which the European Commission decided not to be incl uded in the list under paragraph (1);

3. the active substances, prohibited for placing and use on the market of the European Union.

(2) (Amended, SG No. 8/2011, effective 25.01.2011) The orders under paragraph (1) shall b e published in State Gazette and posted on the Web-site of the Bulgarian Food Safety Agency.

(3) The active substances, intended for manufacturing plant protection products in order to b e placed on the market and used in the Republic of Bulgaria, must be:

1. included in the list under paragraph (1), item 1 or

2. notified to the European Commission for inclusion into the list of active substances, autho rized by the European Union.

Article 15a. (New, SG No. 96/2001, amended, SG No. 26/2006, effective 28.03.2006) (1) (Amended, SG No. 8/2011, effective 25.01.2011) The Minister of Agriculture and Food shall set up by order a Council on plant protection products, as a consultative body on issues, related to pla nt protection products.

(2) (Amended, SG No. 8/2011, effective 25.01.2011, SG No. 28/2011, effective 5.04.2011) The Minister of Agriculture and Food shall determine by order the composition of the Council on plant protection products, to include representatives of the Ministry of Agriculture and Food, the Ministry of Health, the Ministry of Environment and Water, research institutes, etc. (3) (Amended, SG No. 8/2011, effective 25.01.2011) The Minister of Agriculture and Food shall issue rules of organisation of the activity of the Council on Plant Protection Products.

(4) (Amended, SG No. 8/2011, effective 25.01.2011) The Council on Plant Protection Produ cts shall make proposals to the executive director of the Bulgarian Food Safety Agency regarding:

1. authorization of plant protection products in the cases under Article 15d, 15h and 15i;

2. authorization of plant protection products within the framework of mutual recognition of data in accordance with Article 15e;

3. (Amended, SG No. 28/2011, effective 5.04.2011) authorization of parallel trade in plant p rotection products in accordance with Article 15g;

4. authorization of additional uses of plant protection products in accordance with Article 15 d, item 1;

5. broadening of the purposes of plant protection products for minimal uses in accordance wi th Article 15d, item 5;

6. renewal of the authorization for use of plant protection products in accordance with Articl e 15k;

7. extension of terms of validity of authorizations under Article 15l;

8. change of an authorization under Article 15o, paragraph (3);

9. withdrawal of an authorization under Article 15o, paragraph (1);

10. termination of a term of authorization under Article 15o, paragraph (2);

11. denial to issue an authorization;

12. authorization of one-time importation in accordance with Article 16.

(5) (Amended, SG No. 28/2011, effective 5.04.2011) The Council on plant protection produ cts, based on expert appraisals of the biological, physico-chemical properties, the residual substan ces of pesticides in and on foods and feeds of plant and animal origin, the biological, the toxicolo gical and eco-toxicological characteristics and the environmental behavior of plant protection pro ducts, shall take decisions and make proposals under paragraph (4). The decisions shall be adopte d by a majority of two-thirds of members, present at the meeting.

(6) Meetings, at which decisions under paragraph (5) are adopted, shall be deemed regularly held, if attended by two-thirds of all members.

(7) Expert appraisals under paragraph (5) shall be conducted: 1. (Amended, SG No. 8/2011, effective 25.01.2011) by the Bulgarian Food Safety Agency - of the physical and chemical properties of the active substance and the plant protection product; t he biological characteristics of the plant protection product and the residues of pesticides in and o ver foods or feedingstuffs of plant or animal origin;

2. By the Ministry of Health - of the toxicological characteristics of the active substance and the plant protection product;

3. (supplemented, SG No. 8/2011, effective 25.01.2011) by the Ministry of Environment and Water - of the eco-toxicological characteristics of the active substance and the plant protection pr oduct fate and behaviour of the plant protection product in the environment;

(8) (New, SG No. 8/2011, effective 25.01.2011)The expert appraisals under Paragraph 5 ma y also be carried out by external experts who are to be appointed as per the requirements of the O rdinance under Article 14(5).

Article 15b. (New, SG No. 96/2001, amended, SG No. 26/2006, SG No. 8/2011, effective 2 5.01.2011) The executive director of the Bulgarian Food Safety Agency, upon proposal by the Co uncil on plant protection products, shall authorize by an order pursuant to Article 14(1) the placin g on the market and usage of plant protection products, if they:

1. are sufficiently efficient;

2. have no undesirable effect on plants or plant products, which are not to be eliminated;

3. cause no unnecessary suffering and pain to vertebrata, against which they are applied;

4. do not have a harmful impact on the health of people and animals;

5. have no harmful impact on the environment during their application or decomposition, par ticularly as regards:

a) waters, including potable and ground waters;

b) biological species, which are an object of the pest control applied;

6. the type and quantity of their active substances, of harmful admixtures and of all products, which are part of their formulas, may be determined by standardized or validated methods or met hods, proposed by the applicant;

7. the quantities left after the application contemplated, which are of toxicological or eco-tox icological importance, may be determined by determined by standardized or validated methods or methods, proposed by the applicant;

8. their physical and chemical properties are suitable for the purpose of application of the pr oduct and for its storage; 9. residual quantities in agricultural products do not exceed the maximum permissible limits under the Foodstuffs Act;

10. (amended, SG No. 8/2011, effective 25.01.2011) the applicant has paid to the Bulgarian Food Safety Agency a fee for permitting the product in accordance with the tariff under Article 3.

Article 15c. (New, SG No. 96/2001, amended, SG No. 26/2006, effective 28.03.2006) (1) (Amended, SG No. 8/2011, effective 25.01.2011) The applicant shall submit to the Bulgarian Foo d Safety Agency an application for permitting a plant protection product in a form, approved by o rder of the executive director.

(2) (Amended, SG No. 8/2011, effective 25.01.2011) The form of the application under para graph (1) shall be published in State Gazette and posted on the Web-site of the Bulgarian Food Sa fety Agency.

(3) (Amended, SG No. 8/2011, effective 25.01.2011) The Bulgarian Food Safety Agency sh all establish and maintain a register of plant protection products, for which permitting was applie d for.

(4) The form and content of the register under paragraph (3) shall be determined by the Ordi nance under Article 14(5).

Article 15d. (New, SG No. 96/2001, amended, SG No. 26/2006, effective 28.03.2006) (1) I n order to obtain authorization of a plant protection product, which contains active substances, in cluded in the list under Article 15(1) item 1, the following shall be attached to the application:

1. an inventory of the documents submitted;

2. a biological file of the plant protection product, including an assessment of the risk of eac h type of use proposed; each type of use proposed must take into account the terms and restriction s, subject to which the active substance was included into the list under Article 15(1), item 1;

3. (Supplemented, SG No. 28/2011, effective 5.04.2011) a file of the active substance, inclu ding data on its physical, chemical, toxicological and eco-toxicological characteristics and enviro nmental behavior; a separate file shall be submitted in regard to each active substance;

4. (Supplemented, SG No. 28/2011, effective 5.04.2011) a file of the plant protection produc t, including data on its physical, chemical, toxicological and eco-toxicological characteristics and environmental behavior, containing a summary and an evaluation of the data submitted for each t ype of use proposed; each type of use proposed, must take into account the terms and restrictions, subject to which the active substance/s were included into the list under Article 15(1), item 1.

4a. (New, SG No. 13/2008) The assessment under Item 2 and the evaluation and summary u nder Item 4 shall be presented in Bulgarian;

5. a declaration concerning the term for data protection; 6. (Amended, SG No. 28/2011, effective 5.04.2011) document certifying payment of the fee according to the tariff under Article 3.

(2) The specific requirements in regard to the form and content of the information under par agraph (1) shall be determined by the Ordinance under Article 14(5).

(3) Data from the documentation shall be assessed after being received from:

1. (amended, SG No. 8/2011, effective 25.01.2011) the official data bases of the Bulgarian F ood Safety Agency regarding testing and/or data bases of natural and legal persons, approved by t he Bulgarian Food Safety Agency - in regard to data under paragraph (1), item 2;

2. from laboratories, certified for evaluated conformity to the Good Laboratory Practices - in regard to data under paragraph (1), items 3 and 4.

(4) If the data, included in the documentation under paragraph (1), items 2, 3 and 4, were rec eived from foreign data bases and/or laboratories, the applicant shall attach copies of their certific ates.

(5) (Supplemented, SG No. 28/2011, effective 5.04.2011) In the course of authorizing a gen eric product, the applicant shall also submit a letter of authorization of access to protected data us ed in the course of authorization of the generic product or alternative examination of such data.

(6) Data from the documentation shall be evaluated in conformity with uniform principles of evaluation, determined by the Ordinance under Article 14(5).

(7) (Amended and supplemented, SG No. 8/2011, effective 25.01.2011) Evaluation of the da ta from the documentation shall be performed by the persons under Article 15a(7) and (8).

(8) (Amended, SG No. 8/2011, effective 25.01.2011, SG No. 28/2011, effective 5.04.2011) Acting on a proposal from the Council on Plant Protection Products, the executive director of the Bulgarian Food Safety Agency shall authorize by an order the placing on the market and usage of a plant protection product or shall issue a motivated rejection. Such a rejection shall be subject to appeal under the procedure of the Code of Administrative Procedure.

Article 15e. (New, SG No. 26/2006, effective 28.03.2006) (1) A plant protection product, au thorized in an European Union Member State, shall be authorized for placing on the market and u sage in the Republic of Bulgaria by mutual recognition of data, in cases when:

1. the active substances it contains are included in the list under Article 15(1) item 1.

2. the agri-technical, plant protection and climate conditions, in which data on it where obtai ned, including on pests and crops, are similar to those in Bulgaria.

(2) Requirements towards the content of the data under paragraph (1) shall be determined by the Ordinance under Article 14(5). (3) A fee shall be payable for the authorization under paragraph (1) according to the tariff un der Article 3.

(4) (Amended and supplemented, SG No. 8/2011, effective 25.01.2011) Evaluation of the da ta from the documentation shall be performed by the persons under Article 15a(7) and (8).

(5) (Amended, SG No. 8/2011, effective 25.01.2011) Acting on a proposal from the Council on Plant Protection Products, the executive director of the Bulgarian Food Safety Agency shall au thorize by an order the placing on the market and usage of a plant protection product or shall issu e a motivated rejection. Such a rejection shall be subject to appeal under the procedure of the Cod e of Administrative Procedure.

Article 15f. (New, SG No. 26/2006, effective 28.03.2006) (1) In order to obtain authorizatio n for additional uses of a plant protection product, the applicant shall submit to the Bulgarian Foo d Safety Agency data regarding the effectiveness and data regarding the residual quantities, relate d to such additional uses.

(2) The specific requirements in regard to the form and content of the information under par agraph (1) shall be determined by the Ordinance under Article 14(5).

(3) A fee shall be payable for authorization of additional uses of plant protection products un der paragraph (1) according to the tariff under Article 3.

(4) An authorization of additional uses of plant protection products shall nor extend the term for its authorization.

(5) Entitled to submit to the Bulgarian Food Safety Agency proposals for broadening the pur pose of a permitted plant protection product, if such broadening is for minimal use, shall be scient ific research institutes in the field of agriculture, professional consumers of plant protection produ cts or associations thereof, as well as state administrative structures, related to agriculture.

(6) The procedure for authorization of additional uses under paragraph (1) and for broadenin g of the purpose under paragraph (5) shall be determined by the Ordinance under Article 14(5).

Article 15g. (New, SG No. 26/2006, effective 1.01.2008) (1) (Amended, SG No. 28/2011, e ffective 5.04.2011) Persons, holding permits for trading in plant protection products under the pro cedure of Articles 23 and 23a, shall be entitled to apply for permits for parallel trade in the Repub lic of Bulgaria in plant protection products, authorized in this country and in an European Union Member State.

(2) (Amended, SG No. 8/2011, effective 25.01.2011) In the cases under paragraph (1) the pe rsons shall submit to the Bulgarian Food Safety Agency:

1. Application under Article 15c(1);

2. (Amended, SG No. 28/2011, effective 5.04.2011) original label and instructions for use ac companied by a translation thereof in the Bulgarian language for the plant protection product sour ced from the EU Member State within the framework of parallel trade and a draft label for the Re public of Bulgaria referring obligatorily to the product as being the object of parallel trade;

3. (Amended, SG No. 28/2011, effective 5.04.2011) document certifying payment of the fee according to the tariff under Article 3.

(3) (New, SG No. 28/2011, effective 5.04.2011) The Bulgarian Food Safety Agency may as k the applicant to provide a sample of the product applying for a parallel trade permit.

(43) (Amended, SG No. 8/2011, effective 25.01.2011, renumbered from Paragraph 3, amend ed, SG No. 28/2011, effective 5.04.2011) The persons referred to in Article 15a (7) and (8) shall conduct an assessment of the identity of the plant protection product being applied for with the pr oduct already permitted in the country and shall make this assessment available to the Council on Plant Protection Products within two months of receiving the documentation referred to in paragr aph 2. A plant protection product shall be considered identical with the product already permitted in the country if:

1. it is manufactured by the same producer or producer-related facility, or under a license usi ng the same manufacturing process;

2. is identical according to specification and content of active substances, as well as accordin g to formulation type.

3. is identical or equivalent in terms of presence of co-formulants and size, material and desi gn of the package with a view to safeguarding human or animal health and the environment from the adverse impacts that might compromise its safety.

(5) (Renumbered from Paragraph 4, amended, SG No. 28/2011, effective 5.04.2011) Parallel trade in a plant protection product may be applied for, provided that:

1. it was authorized in an European Union Member State;

2. its active substances were manufactured by the same producer, as that of the active substa nces of the plant protection product, authorized in the Republic of Bulgaria;

3. it was manufactured by the same producer, as the plant protection product, authorized in t he Republic of Bulgaria;

4. the content of its formulation is identical to the formulation of the plant protection product authorized in the Republic of Bulgaria, or is so similar that any differences do not influence the e ffectiveness and safety of the product for humans, animals and the environment.

(6) (Amended, SG No. 8/2011, effective 25.01.2011, renumbered from Paragraph 5, SG No. 28/2011, effective 5.04.2011) The Bulgarian Food Safety Agency may require additional informa tion from the manufacturer of the plant protection product, authorized in the Republic of Bulgaria. (7) (Amended, SG No. 8/2011, effective 25.01.2011, renumbered from Paragraph 6, amende d, SG No. 28/2011, effective 5.04.2011) Acting on a proposal from the Council on Plant Protecti on Products, the executive director of the Bulgarian Food Safety Agency shall authorize by an or der the parallel trade in a plant protection product or shall issue a motivated rejection. Such a reje ction shall be subject to appeal under the procedure of the Code of Administrative Procedure.

(8) (Amended, SG No. 8/2011, effective 25.01.2011, renumbered from Paragraph 7, amende d, SG No. 28/2011, effective 5.04.2011) On the legal grounds of the order under paragraph (7) ex ecutive director of the Bulgarian Food Safety Agency or an official authorised by the executive di rector shall issue to the applicant a certificate, valid until expiry of the term of the product, author ized in the Republic of Bulgaria

(9) (Renumbered from Paragraph 8, SG No. 28/2011, effective 5.04.2011) Requirements to wards the content of the information under paragraph (2) shall be determined by the Ordinance u nder Article 14(5).

Article 15h. (New, SG No. 26/2006, effective 28.03.2006) (1) (Amended, SG No. 8/2011, e ffective 25.01.2011) In order to obtain authorization for a plant protection product, containing act ive substances, which are not included in the list under Article 15(1) item 1, but had been notified for inclusion, the applicant shall submit to the Bulgarian Food Safety Agency the following docu ments:

1. application under Article 15c(1);

2. data regarding their effectiveness based on tests, conducted in the Republic of Bulgaria;

3. documentation, including data on:

a) residual quantities of the product in plants and plant products

b) (Supplemented, SG No. 28/2011, effective 5.04.2011) physical and chemical properties o f the active substances and plant protection products, which are relevant to their application;

c) the methods of analysis of the active substances, the admixtures and the other components of plant protection products and oddments thereof.

4. (Supplemented, SG No. 28/2011, effective 5.04.2011) documentation, including data for e valuation of toxicological and eco-toxicological characteristics and environmental behavior of the active substances and of the plant protection product;

5. a draft label;

(2) (Amended and supplemented, SG No. 8/2011, effective 25.01.2011) Evaluation of the da ta from the documentation shall be performed by the persons under Article 15a(7) and (8). (3) (Amended, SG No. 8/2011, effective 25.01.2011, SG No. 28/2011, effective 5.04.2011) Acting on a proposal from the Council on Plant Protection Products, the executive director of the Bulgarian Food Safety Agency shall authorize by an order the placing on the market and usage of a plant protection product or shall issue a motivated rejection. Such a rejection shall be subject to appeal under the procedure of the Code of Administrative Procedure.

(4) Authorization of a plant protection product under paragraph (1) shall be valid for a term of three years.

(5) If during the term under paragraph (4) the active substances are included into the list und er Article 15(1) item 1, the authorization of the plant protection product shall be renewed under th e terms of Article 15k. In such a case the certificate of authorization issued shall be valid until the issue of a new certificate.

(6) If by the time of expiry of the term under paragraph (4) the active substances will not yet have been included into the list under Article 15(1) item 1, the term of authorization of the plant p rotection product shall be extended ex-officio by three years.

(7) Requirements towards the content of the information under paragraph (1) shall be determ ined by the Ordinance under Article 14(5).

Article 15i. (New, SG No. 26/2006, effective 28.03.2006) (1) Application for authorization i n this country made be made for a plant protection product, containing at least one new active sub stance, not included into the list under Article 15(1) item 1, if the new active substance had been notified for inclusion therein.

(2) (Amended, SG No. 8/2011, effective 25.01.2011) In order to obtain authorization for a pl ant protection product, containing new active substances, not included into the list under Article 1 5(1) item 1, but which had been notified for inclusion therein, the applicant shall submit to the Bu lgarian Food Safety Agency documentation in accordance with the Ordinance under Article 14(5).

(3) Data from the documentation under paragraph (2) shall be prepared based on the file, wh ich at the time of notification was accepted as complete.

(4) (Amended and supplemented, SG No. 8/2011, effective 25.01.2011) Evaluation of the do cumentation under paragraph (2) shall be performed by the persons under Article 15a(7) and (8).

(5) (Amended, SG No. 8/2011, effective 25.01.2011) Acting on a proposal from the Council on Plant Protection Products, the executive director of the Bulgarian Food Safety Agency shall au thorize by an order the placing on the market and usage of a plant protection product or shall issu e a motivated rejection. Such a rejection shall be subject to appeal under the procedure of the Cod e of Administrative Procedure.

(6) The plant protection product under paragraph (1) shall be authorized for a term of three y ears. (7) A fee shall be payable for the authorization under paragraph (1) according to the tariff un der Article 3.

(8) If during the term under paragraph (6) the active substances are included into the list und er Article 15(1) item 1, the authorization of the plant protection product shall be renewed under th e terms of Article 15k. In such a case the certificate of authorization issued shall be valid until the issue of a new certificate.

(9) If by the time of expiry of the term under paragraph (6) the active substances will not yet have been included into the list under Article 15(1) item 1, the term of authorization of the plant p rotection product shall be extended ex-officio by three years.

Article 15j. (New, SG No. 26/2006, effective 28.03.2006) The plant protection products sha ll be authorized for a term of:

1. ten years, if they contain active substances, included in the list under Article 15(1) item 1.

2. three years, if the active substances have been notified, have not been included in the list under Article 15(1) item 1 and there is no decision to include them into it.

Article 15k. (New, SG No. 26/2006, effective 28.03.2006) (1) (Amended, SG No. 28/2011, effective 5.04.2011) The plant protection products, authorized for placing on the market and usag e, as well as those authorized under Articles 15h and 15i, shall be subject to renewal of the author ization at the time, when the active substances they contain, are included in the list under Article 15(1) item 1.

(2) (Amended, SG No. 8/2011, effective 25.01.2011) To renew the authorization under para graph (1), the applicant shall submit to the Bulgarian Food Safety Agency an application in accor dance with Article 15c(1) and:

1. (Supplemented, SG No. 28/2011, effective 5.04.2011) documentation regarding the identi ty or equivalence of the active substance, contained in the plant protection product, included in th e list under Article 15(1) item 1 or written consent for access to the data, used when including the active substance into the list under Article 15(1) item 1;

(3) The form and content of the data under paragraph (2), as well as the deadline for their ev aluation, shall be determined by the Ordinance under Article 14(5).

(4) (Amended, SG No. 8/2011, effective 25.01.2011, supplemented, SG No. 28/2011, effecti ve 5.04.2011) The persons under Article 15a(7) shall evaluate the identity or equivalence of the a ctive substance, contained in the plant protection product, to the active substance, included in the list under Article 15(1) item 1. If no identity or equivalence is established, Article 15o(2) item 2 s hall apply. (5) (Amended, SG No. 8/2011, effective 25.01.2011, supplemented, SG No. 28/2011, effecti ve 5.04.2011) In case of proven identity or equivalence under paragraph (4), the applicant shall s ubmit to the Bulgarian Food Safety Agency:

1. (Supplemented, SG No. 13/2008) a biological file, including an assessment of the risk, pre sented in Bulgarian language, of each type of use proposed, in accordance with the terms and rest rictions, subject to which the active substance was included into the list under Article 15(1), item 1;

2. (Amended and supplemented, SG No. 13/2008) a product file, including a summary and a n evaluation, both in Bulgarian language, of the data submitted regarding each type of use propos ed, subject to which the active substance was included into the list under Article 15(1), item 1;

(6) The documents under paragraph (5) shall be submitted individually for each formulation, authorized in the Republic of Bulgaria.

(7) The form and content of the data under paragraph (5), as well as the deadline for their ev aluation, shall be determined by the Ordinance under Article 14(5).

(8) Data from the documentation shall be evaluated in conformity with uniform principles of evaluation, determined by the Ordinance under Article 14(5).

(9) (Amended and supplemented, SG No. 8/2011, effective 25.01.2011) Evaluation of the da ta from the documentation shall be performed by the persons under Article 15a(7) and (8). Evalua tors of the documentation shall draw up reports, which they shall submit to the a Council on Plant Protection Products with the view to draw up a proposal to the executive director of the Bulgarian Food Safety Agency for renewal of the authorization of a plant protection product or for terminati on of the authorization term.

(10) If a plant protection product contains more than one active substance, the authorization shall be renewed immediately after the inclusion of one of them into the list under Article 15(1), i tem 1, while applying paragraphs (2), (3) and (4). This procedure shall be applied when including each subsequent active substance into the list under Article 15(1), item 1.

(11) (Supplemented, SG No. 28/2011, effective 5.04.2011) Upon the inclusion of all active s ubstances, which the plant protection product contains, into the list under Article 15(1), item 1, an d in case of proven identity or equivalence, paragraphs (5), (6), (7), (8) and (9) shall apply.

(12) The certificate of the authorization, obtained prior to the inclusion of the active substan ce(-s), into the list under Article 15(1), item 1, shall be valid until:

1. a new certificate of the authorization is issued;

2. inclusion of at least one of the active substances into the lists under Article 15(1), item 1, i tem 2 or 3, in which case Article 15o(1) item 2 or Article 15o(2) item 3 shall apply;

3. (Supplemented, SG No. 28/2011, effective 5.04.2011) proven absence of identity or equiv alence under paragraph (4);

4. termination of the term under paragraph (9).

Article 15l. (New, SG No. 26/2006, effective 28.03.2006) In order to extend the term of the authorization, obtained under the procedure of Article 15d or renewed under the procedure of Art icle 15k, the applicant must submit to the Bulgarian Food Safety Agency an application six mont hs prior to expiry of the term of the certificate issued and to pay the fee in accordance with the tar iff under Article 3.

Article 15m. (New, SG No. 26/2006, effective 28.03.2006) (1) (Amended, SG No. 8/2011, effective 25.01.2011) Upon request by the applicant, the executive director of the Bulgarian Food Safety Agency or an official authorised by the executive director shall issue a new certificate:

1. if changes have occurred in the data, which are not related to any impact on the health of humans, animals and the environment or to the effectiveness of the plant protection products (hea dquarters and address of the certificate holder, product name, etc.);

2. in case of transfer of rights over an authorized plant protection product to another person.

3. (New, SG No. 28/2011, effective 5.04.2011) in case of assigning subsequent trade names to an already authorized plant protection product.

(2) (Amended, SG No. 8/2011, effective 25.01.2011, supplemented, SG No. 28/2011, effecti ve 5.04.2011) In the cases under paragraph (1) item 2 and 3, the origin and the nature of the activ e substance(-s) and of the finished product, as well as the production technology, Must be the sa me, and both parties shall provide evidence thereof to the Bulgarian Food Safety Agency.

(3) The applicant shall pay a fee in the cases under paragraph (1) according to the tariff unde r Article 3.

Article 15n. (New, SG No. 26/2006, effective 28.03.2006) In the event of change in data or new data become available regarding the impact of the plant protection product authorized on the health of humans, animals and the environment, the holder of the certificate of authorization must notify in writing the Bulgarian Food Safety Agency without delay and must submit documentatio n for evaluation of the data.

Article 15o. (New, SG No. 26/2006, effective 28.03.2006) (1) (Amended, SG No. 8/2011, e ffective 25.01.2011) Acting on a proposal from the Council on Plant Protection Products, the exe cutive director of the Bulgarian Food Safety Agency shall repeal by his/her order the authorizatio n of a plant protection product, in cases when:

1. it no longer fulfills the conditions for authorization; 2. it poses a danger for the health of humans, animals or the environment or the active substa nce, part of the product contents, is included into the list under Article 15(1), item 3.

(2) (Amended, SG No. 8/2011, effective 25.01.2011) The executive director of the Bulgaria n Food Safety Agency shall terminate by order the term of the authorization, when:

1. the holder of the certificate so requests;

2. (Supplemented, SG No. 28/2011, effective 5.04.2011) the authorization of the plant prote ction product was not extended or identity or equivalence was not proven in accordance with Arti cle 15k;

3. the active substance, contained in the product, is included in the list under Article 15(1) it em 2.

(3) (Amended, SG No. 8/2011, effective 25.01.2011) Acting on a proposal from the Council on Plant Protection Products, the executive director of the Bulgarian Food Safety Agency shall ch ange by his/her order the authorization of the plant protection product, when:

1. it is scientifically proven that the mode of use of the plant protection product and the dosa ges applied, may be changed;

2. the holder of the certificate so requests and quotes valid reasons for the changes.

(4) (New, SG No. 28/2011, effective 5.04.2011) In the cases referred to in paragraph 3, the c ertificate holder shall submit the following to the Bulgarian Food Safety Agency:

1. the Application referred to in Article 15c (1);

2. data on the change whose form, contents and assessment deadline are laid down in the ord inance referred to in Article 14 (5); the data assessment shall be made by the persons referred to i n Article 15a (7) and (8);

3. Document certifying payment of the fee according to the tariff under Article 3.

(5) (Amended, SG No. 8/2011, renumbered from Paragraph 4, SG No. 28/2011, effective 5. 04.2011) The orders under paragraphs (1), (2) and (3) may be challenged under the procedure of t he Code of Administrative Procedure.

Article 15p. (New, SG No. 26/2006, effective 28.03.2006) (1) In the cases under Article 15 o(1), the placing on the market and usage of plant protection products shall be halted forthwith an d a term of up to 6 months shall be set for withdrawing the quantities available from the market.

(2) In the cases under Article 15o(2) the order shall prescribe a term of up to 18 months for c onsuming domestically the available quantities of the plant protection product.

Article 15q. (New, SG No. 26/2006, effective 28.03.2006) (1) (Amended, SG No. 8/2011, e ffective 25.01.2011) All persons engaged in expert appraisals under Article 15a(7) and (8) shall e nsure protection of data from the documentation, submitted for authorizing plant protection produ cts under a procedure, determined in the Ordinance under Article 14(5).

(2) (Amended, SG No. 8/2011, effective 25.01.2011) Members of the Council on Plant Prote ction Products shall and the experts, performing evaluation of the data from the documentation, s hall sign declarations for confidentiality of data. The applicants shall notify the Bulgarian Food S afety Agency, when the information provided ceases to be confidential.

(3) Data regarding new active substances shall be protected for a term of 10 years as of the d ate of its original inclusion into the lists of active substances, authorized in the European Union.

(4) Data regarding existing active substances shall be protected for a period of 5 years as of t he date of their original inclusion into the lists of active substances, authorized in the European U nion.

(5) Any supplementary data regarding existing active substances, made available in relation to their inclusion into the list of active substances, authorized for use in the European Union, shal l be protected for a period of 5 years as of the date of the decision to include them unto the list.

(6) Data on plant protection products shall be protected for a period of 10 years as of the dat e of the original authorization of the products in any European Union Member State, when such a uthorization had been issued after the inclusion of the active substance(-s) in the product into the list of active substances, authorized in the European Union, or for a period of 10 years from the d ate of the original authorization of the product in the Republic of Bulgaria, where such authorizati on was issued prior to the inclusion of the active substance(-s) in the product into the list of active substances, authorized in the European Union.

(7) (Amended, SG No. 8/2011, effective 25.01.2011) When authorizing plant protection pro ducts, the Bulgarian Food Safety Agency may use the information, submitted by previous applica nts, where:

1. the prior applicant has given its consent in writing;

2. the terms for protection of data under paragraphs (3) - (6) will have expired.

(8) The following shall not be treated as confidential:

1. name and content of active substances and the name of the plant protection product;

2. (amended, SG No. 8/2011, effective 25.01.2011) names of other substances, which are ha rmful within the meaning of the Protection against the Harmful Impact of Chemical Preparations and Mixtures Act;

3. physical and chemical data regarding the active substances and plant protection products;

4. the methods for rendering harmless active substances and the product in the event of accid ental scattering or spillage of a plant protection product;

5. the summary of the testing results for establishing effectiveness and absence of harmful i mpact of plant protection products on health of humans, animals and the environment;

6. the measures for preventing or reducing the risk during application, storage and transporta tion of plant protection products, fire protection measures or in other risk events;

7. the methods for analysis in order to determine the active substances, technological admixt ures and other components of a plant protection product of toxicological or eco-toxicological sign ificance and any oddments thereof;

8. the methods for destruction of a plant protection products and its packaging;

9. the ways for rendering of first aid and medical assistance to individuals who suffered dam age.

Article 16. (Amended, SG Nos. 96/2001, 26/2006, effective 28.03.2006) (1) (Amended, SG No. 8/2011, effective 25.01.2011, SG No. 28/2011, effective 5.04.2011) The executive director of the Bulgarian Food Safety Agency shall be entitled, by way of exception, to permit by his/her ord er the placing on the market of certain quantities of a plant protection product for a limited and co ntrollable use in certain regions for a period of up to 120 days within one calendar year, if an unf oreseen threat to plants emerges, which can not be prevented in another way.

(2) The permit under paragraph (1) shall be issued upon the proposal of the Council on Plant Protection Products, based on expert evaluations, adopted unanimously, of the effectiveness of th e plant protection product and its toxicological and eco-toxicological characteristics.

(3) (Supplemented, SG No. 8/2011, effective 25.01.2011) The evaluations under paragraph (2) shall be adopted in accordance with Article 15a(7) and (8).

(4) The contents of the documentation required and the term of issuance of the order shall be determined by the Ordinance under Article 14(5).

(5) (Amended, SG No. 8/2011, effective 25.01.2011) Use of the product under paragraph 1 s hall take place under the control of the respective regional food safety directorate, in the area of which the product is used.

(6) A fee shall be payable by the applicant for the issuance of authorization under paragraph (1) according to the tariff under Article 3.

Article 16a. (New, SG No. 96/2001, amended, SG No. 26/2006, effective 28.03.2006) (1) (Supplemented, SG No. 28/2011, effective 5.04.2011) The Bulgarian Food Safety Agency shall is sue a permit and exercise control over persons, conducting tests of unauthorized plant protection products for research and experimental purposes.

(2) (Amended, SG No. 28/2011, effective 5.04.2011) The following shall be submitted to th e Bulgarian Food Safety Agency for the purpose of issuing a permit under paragraph 1.

1. application conforming to a model approved by the Executive Director of the Bulgarian F ood Safety Agency;

2. plant protection product safety data sheet in the Bulgarian language in accordance with Re gulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 200 6 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Coun cil Regulation (EEC) No. 793/93 and Commission Regulation (EC) No. 1488/94 as well as Coun cil Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC;

3. document certifying payment of the fee according to the tariff under Article 3.

(3) (New, SG No. 28/2011, effective 5.04.2011) Within 14 days of filing the application refe rred to in paragraph 2, the Executive Director of the Bulgarian Food Safety Agency or an official authorized by the Executive Director shall issue an authorization for testing for the purpose of res earch and experiment according to a model laid down in the ordinance referred to in Article 19 (4), or shall issue a motivated rejection.

(4) (New, SG No. 28/2011, effective 5.04.2011) The authorization referred to in paragraph 3 shall be valid for one year.

(5) (New, SG No. 28/2011, effective 5.04.2011) The rejection referred to in paragraph 3 shal l be subject to appeal according to the procedure laid down in the Code of Administrative Proced ure.

Article 16b. (New, SG No. 28/2011, effective 5.04.2011) Any testing on unauthorized plant protection products for the purpose of research and experiment shall take place under the conditio ns and according to the procedure laid down in the ordinance referred to in Article 19 (4).

Article 17. (Amended, SG No. 96/2001, No. 26/2006, effective 28.03.2006) (1) The plant pr otection products shall be offered on the market with labels in the Bulgarian language.

(2) (Amended, SG No. 8/2011, effective 25.01.2011) Plant protection products shall be class ified, packaged and labeled in accordance with the requirements of the Protection Against the Har mful Impact of Chemical Substances and Mixtures Act.

(3) The specific requirements and the procedure for labelling of plant protection products sh all be determined by Ordinance of the Council of Ministers.

(4) Plant protection products shall be offered on the market in original sealed manufacturer p ackages or re-packaged by a person, holding an authorization for such purpose.

(5) The material, of which the package of a plant protection product was made, as well as its capacity, shall be authorized when the product is authorized. Article 18. (Amended, SG No. 96/2001, No. 26/2006, effective 28.03.2006) (1) (Amended, SG No. 28/2011, effective 5.04.2011) The Bulgarian Food Safety Agency shall control the produ ction, repackaging, storage, placing on the market and use in the country of plant protection prod ucts with regard to the formulation, the labelling, the contents of the labels and their corresponde nce with the characteristics approved at the time of granting the authorization.

(2) (Amended, SG No. 28/2011, effective 5.04.2011) Placing on the market and using plant protection products, which have not been permitted or are unfit for use, shall be prohibited.

(3) The Bulgarian Food Safety Agency shall control the import of active substances, intende d for the formulation of plant protection products under Article 15(3).

(4) The Bulgarian Food Safety Agency shall control the correspondence between the biologi cal agents and the pheromones with the documents accompanying them.

Article 18a. (New, SG No. 28/2011, effective 5.04.2011) (1) In cases of identifying any pla nt protection products as unauthorized, unfit for use or not complying with the prescribed physica l and/or chemical properties, the inspection authorities of the Bulgarian Food Safety Agency shall suspend their sale and use and shall give orders for the following to be done at their holder's expe nse:

1. taking the products out of the country's territory;

2. destroying the products in accordance with the Waste Management Act;

(2) The measures referred to in paragraph 1 shall be enforced based on prescriptions, a copy of which shall be handed over to the holder of the products or his or her agent.

(3) The individual administrative acts referred to in paragraph 2 may be appealed against bef ore the Director of the respective Regional Food Safety Agency according to the procedure laid d own in the Code of Administrative Procedure. The appeal shall not suspend the enforcement.

(4) In cases of establishing a violation and enforcing a measure as provided for in paragraph 1, the inspection authorities shall forthwith notify the Executive Director of the Bulgarian Food S afety Agency whereupon, based on the findings, the Executive Director may issue an order aimed at suspending immediately the placing on the market and the use of a particular lot of plant protec tion products while instructing the holder of the authorization certificate to withdraw the lot in qu estion from the market not later than one month thereafter. The order shall mandatorily stipulate t he taking of the lot out of the country's territory or its destroying in accordance with the Waste M anagement Act.

(5) The order referred to in paragraph 4 may be appealed against according to the procedure laid down in the Code of Administrative Procedure. The appeal shall not suspend the enforcemen t.

(6) Adhering to the deadlines laid down in the acts referred to in paragraphs 1 and 4, the hol der of the products or the certificate holder shall submit written proof of enforcement of the meas ures to the Bulgarian Food Safety Agency.

Article 19. (Amended, SG No. 96/2001, No. 26/2006, effective 28.03.2006) (1) (Amended, SG No. 28/2011, effective 5.04.2011) Plant protection products, intended for authorization for pla cing on the market and use, shall be subject to biological testing, except in the cases under Article s 15e and 15g.

(2) (Amended, SG No. 8/2011, effective 25.01.2011) The Bulgarian Food Safety Agency sh all be an official body on the territory of the Republic of Bulgaria for performing biological testin g of plant protection products.

(3) (Amended, SG No. 8/2011, effective 25.01.2011, supplemented, SG No. 28/2011, effecti ve 5.04.2011) Biological testing of plant protection products shall be performed by the official tes t facilities of the Bulgarian Food Safety Agency and by the facilities of natural and legal persons, approved by it in accordance with the requirements of Good Experimental Practice and Good Lab oratory Practice. In case of need, the Bulgarian Food Safety Agency shall commission biological testing of plant protection products to research institutes under its methodological guidance.

(4) (Amended, SG No. 8/2011, effective 25.01.2011) Biological testing of products and the approval of facilities of natural and legal persons referred to in Paragraph (3) shall be implemente d under terms and procedure determined with a regulation issued by the Minister of Agriculture a nd Food.

(5) Fees shall be payable by the applicant for biological testing and for approval of test facili ties of natural and legal persons under paragraph (3) according to the tariff under Article 3.

(6) (Amended, SG No. 8/2011, effective 25.01.2011) Plant protection products, intended for biological testing under paragraph (1), shall be imported into this country under cover of an impo rt certificate, certified by the executive director of the Bulgarian Food Safety Agency or an offici al authorised by the executive director, under the terms and procedure of the Ordinance under par agraph (4).

(7) Plant protection products, intended for biological testing under paragraph (1), shall have an approved formulation and a trade name.

Article 20. (Amended, SG No. 96/2001, No. 26/2006, effective 28.03.2006) Annually until March 1, the Minister of Agriculture and Food, the Minister of Environment and Water and the Minister of Health shall approve a list of the biological agents, which may be imported and used i n this country, which shall be published in State Gazette.

Article 21. (Amended, SG No. 96/2001, No. 26/2006, effective 28.03.2006) (1) The Bulgari an Food Safety Agency shall publish a list of the plant protection products, authorized for placing on the market and use, of the registered fertilizers, soil ameliorators and nutritious media.

(2) The Bulgarian Food Safety Agency shall publish the lists under Article 15(1) and a list o f the active substances notified. (3) (Amended, SG No. 43/2008) The list under paragraph (1) shall be posted on the Web-sit e of the Bulgarian Food Safety Agency, updated with each change and be made available ex-offic io for public access to the Agriculture regional directorates.

Article 22. (Amended, SG No. 96/2001, No. 26/2006, No. 8/2011, effective 25.01.2011, sup plemented, SG No. 28/2011, effective 5.04.2011) Advertisement of plant protection products ma y be conducted only in conformity with the terms, under which it was authorized in the Republic of Bulgaria and in conformity with Article 4 of the Protection Against the Harmful Impact of Che mical Substances and Mixtures Act. Advertising unauthorized plant protection products shall be p rohibited.

Article 23. (Amended, SG No. 96/2001, No. 26/2006, SG No. 8/2011, effective 25.01.2011, SG No. 28/2011, effective 5.04.2011) The wholesale or retail trade in plant protection products a nd the activities involving re-packaging of plant protection products, fumigation and decontamina tion of areas, premises and plant produce against pests shall be performed by persons holding a p ermit issued by the Executive Director of the Bulgarian Food Safety Agency.

(2) Such permit shall be issued for a term of 5 years and may not be ceded.

(3) In order to obtain the permit under paragraph 1, the persons shall be traders within the m eaning of the Commerce Act and shall have a higher education in agricultural engineering or be o n contractual terms with a person who has such education and, in cases involving performance of pest control through fumigation and decontamination of areas, premises and plant produce, shall have completed a training course in fumigation provided by a higher education or research institu te according to a curriculum endorsed by the Executive Director of the Bulgarian Food Safety Ag ency.

(4) In order to perform the activities referred to in paragraph 1, the persons shall dispose of f acilities complying with the requirements laid down in the ordinances referred to in Articles 23c a nd 23d as follows:

1. for wholesale trade - warehouse;

2. for retail trade - farm chemicals shop;

3. for repackaging - repackaging shop;

4. for pest control through fumigation and decontamination of areas, premises and plant prod uce - storage facility (cell);

(5) To obtain a permit under paragraph 1, the persons shall submit an application conformin g to a model approved by the Executive Director of the Bulgarian Food Safety Agency to the Dir ector of the respective Regional Food Safety Department.

(6) Certified copies of the following documents shall also be enclosed with the application r eferred to in paragraph 5: 1. Certificate of Good Standing, or Unified Identity Code (UIC) of the trader;

2. Diploma of Higher Education in Agricultural Engineering held by the person, or Contract with a person who has such education;

3. Certificate under Article 87 (6) of the Tax and Social Insurance Procedure Code;

4. Property Deed or Certificate of Right of Use for the facility where the activity will take pl ace;

5. Document certifying the putting of the facility into operation and specifying its purpose, a s selected to correspond with the activity being applied for, issued according to the procedure laid down in the Spatial Development Act.

6. List of repackaging equipment - in the cases referred to in paragraph 4, item 3.

7. Certificate of completed training course in fumigation by the person - in the cases referred to in paragraph 4, item 4;

8. Document certifying payment of a fee for document processing and opinion issuance acco rding to the tariff under Article 3.

(7) The persons employed as shop-assistants at farm chemicals shops shall have a higher edu cation in agricultural engineering or high-school professional education in plant growing.

(8) The persons involved in repackaging of plant protection products shall have a written aut horization for repackaging issued by the manufacturer of the plant protection product or a person authorized by the manufacturer. The authorization shall refer to the names of the manufacturer an d the products, as well as to the term for which the manufacturer issued the authorization for repa ckaging. A copy of the authorization shall be submitted to the respective Regional Food Safety D epartment prior to starting performance of the activity.

(9) Specific requirements for pest control through fumigation and decontamination of areas, premises and plant produce shall be laid down in an ordinance issued by the Minister of Agricult ure and Food.

Article 23a. (New, SG No. 26/2006, effective 28.03.2006) (1) (Amended, SG No. 8/2011, e ffective 25.01.2011, SG No. 28/2011, effective 5.04.2011) Within 7 days of submission of the do cuments under Article 23, paragraphs (5) - (6), the regional food safety directorate shall review th em and if omission or incorrect data are found, shall advise in writing the applicant thereof and se t a deadline for their correction.

(2) If the applicant fails to correct the omissions within the deadline under paragraph (1), the procedure for issuance of the permit shall be discontinued.

(3) (Amended, SG No. 8/2011, effective 25.01.2011, SG No. 28/2011, effective 5.04.2011) I f the documentation submitted is complete, a site inspection shall be carried out and a written opi nion drawn up within three days.

(4) (Amended, SG No. 8/2011, SG No. 28/2011, effective 5.04.2011) Within 14 days of issu ing the opinion, the executive director shall issue an authorization or a motivated rejection.

(5) (Supplemented, SG No. 28/2011, effective 5.04.2011) A fee shall be payable for the issu ance of authorization under paragraph (4) according to the tariff under Article 3, the rate of which shall be fixed depending on the number of sites where the activity will take place.

(6) (Amended, SG No. 8/2011, effective 25.01.2011) The rejection under paragraph (4) shall be subject to appeal under the procedure of the Code of Administrative Procedure.

(7) (New, SG No. 28/2011, effective 5.04.2011) A Register of permits issued and such reject ed under Article 23 or withdrawn under Article 23b shall be established and maintained at the Bu lgarian Food Safety Agency containing the following:

1. type, number and date of the permit;

2. trader's name, company and Unified Identity Code or BULSTAT code;

3. trader's headquarters, registered office and agent.

4. type and address of the facility / facilities (warehouse, farm chemicals shop, repackaging s hop, storage facility (cell));

5. name of the person / persons responsible for carrying out the activity at the facility;

6. manufacturer's name, names of the plant protection product / products and timeline in cas es involving grant of a permit for repackaging;

7. changes to circumstances previously entered;

8. number and date in cases involving refusal to grant a permit;

9. number and date in cases involving withdrawal of a permit previously granted;

(8) (New, SG No. 28/2011, effective 5.04.2011) The Register shall be posted on the web-site of the Bulgarian Food Safety Agency and shall be updated upon any change.

(9) (New, SG No. 28/2011, effective 5.04.2011) The holder of the permit under Article 23 s hall notify the respective Regional Food Safety Department of any changes to already entered cir cumstances within 7 days of their occurrence.

Article 23b. (New, SG No. 26/2006, effective 28.03.2006) (1) (Amended, SG No. 8/2011, e ffective 25.01.2011) The executive director of the Bulgarian Food Safety Agency shall issue an o rder for withdrawal of the authorization issued: 1.(Supplemented, SG No. 28/2011, effective 5.04.2011) for a term of one year - if establishe d that the authorization was issued based on documents of untrue content or in cases of establishi ng trade in unauthorized plant protection products;

2. (Amended, SG No. 13/2008, SG No. 8/2011, effective 25.01.2011) for a term of two year s - upon more than two penal orders issued within a period of one year for violations committed u nder this Act;

3. (New, SG No. 28/2011, effective 5.04.2011) for a term of 6 months - in cases of establishi ng repackaging of plant protection products without relevant permit under Article 23 (8);

4. (New, SG No. 28/2011, effective 5.04.2011) for a term of three months - in cases of establ ishing trading in plant protection products by a person lacking the required education in accordan ce with Article 23 (7);

5. (Renumbered from Item 3, SG No. 28/2011, effective 5.04.2011) in case of dissolution of the legal person or of death of the sole trader.

(2) Persons, whose authorization was withdrawn, may apply for new ones after expiry of the term, for which the authorization was withdrawn under the procedure of Articles 23 and 23a.

(3) (New, SG No. 13/2008) Any appeal of the order under Paragraph 1 shall not stay its exec ution.

Article 23c. (New, SG No. 26/2006, amended and supplemented, SG No. 28/2011, effective 5.04.2011) The Bulgarian Food Safety Agency shall exercise control over the placing on the mar ket and use of plant protection products according to a procedure and method laid down in a regul ation issued by the Minister of Agriculture and Food.

Article 23d. (New, SG No. 26/2006, effective 28.03.2006) Requirements in regard to wareh ouse facilities for, transportation and storage of plant protection products, shall be regulated by an ordinance of the Council of Ministers.

Article 24. (Amended, SG No. 96/2001, repealed, SG No. 26/2006, effective 28.03.2006). Section V Fertilisers, soil ameliorators, biologically active substances a nd nutrient substrates (New, SG No. 96/2001)

Article 24a. (1) (Amended, SG No. 8/2011, effective 25.01.2011) Fertilisers, soil ameliorato rs, biologically active substances and nutrient substrates which are registered at the Bulgarian Fo od Safety Agency shall be placed on the market.

(2) The products referred to in Paragraph 1 shall be registered on the basis of positive results of the biological testing for efficiency and harmlessness for the people, the animals and the envir onment under the conditions for use prescribed by the producer. Each registered product shall be given a registration number.

(3) New products which are not registered in the country shall be subject to biological testin g.

(4) (Amended, SG No. 8/2011, effective 25.01.2011) The biological testing of products shall be organised and controlled by the Bulgarian Food Safety Agency. The applicant shall pay a fee f or the biological testing according to the tariff under Article 3(4) of the Bulgarian Food Safety A gency Act.

(5) (Amended, SG No. 8/2011, effective 25.01.2011) The terms and procedure for biological testing, registration, use and control of the products referred to in Paragraph 1 shall be provided with a regulation issued by the Minister of Agriculture and Food.

Article 24b. (1) The registration of products under Article 24a, Paragraph 1, shall be cancell ed upon the occurrence of a new effect or when in the process of use it is found that the product n o longer meets the requirements for harmlessness to people, animals or the environment. The imp ort, the storage and the distribution of a product with cancelled registration shall be prohibited.

(2) The producers or the importers of the products referred to in Article 24a shall be obliged to inform the Bulgarian Food Safety Agency of the occurrence of new facts about the impact of t hese products, connected with their harmlessness to people, animals or the environment.

(3) The producers and the importers shall be obliged to provide additional information to the Bulgarian Food Safety Agency and to conduct test trials necessary for establishing the circumstan ces referred to in Paragraph 1.

(4) (New, SG No. 28/2011, effective 5.04.2011) Beyond the cases referred to in paragraph 1, the registration may be cancelled on request by its holder.

Article 24c. (1) (Supplemented, SG No. 26/2006, amended, SG No. 28/2011, effective 5.04. 2011) (1) The following shall not be subject to registration:

1. inorganic fertilizers having the `EC fertilizer' identification marking;

2. waste products and sludge from wastewater treatment processes;

3. secondary agricultural or non-agricultural products of natural origin, even when mixed to gether, obtained through non-chemical treatment.

(2) The `EC fertilizer' marking shall only be applied in cases where the requirements of Reg ulation (EC) No. 2003/2003 are complied with.

Article 24d. (Amended, SG No. 28/2011, effective 5.04.2011) When placed on the market, each batch of products referred to in Article 24a, Paragraph 1, shall be accompanied by a quality certificate.

Article 24e. (1) (Amended and supplemented, SG No. 28/2011, effective 5.04.2011) Control over the fertilizers, soils ameliorators, biologically active substances and nutrient substrates and c ontrol of the compliance with the requirements of Regulation (EC) No. 2003/2003 shall be exerci sed by the Bulgarian Food Safety Agency.

(2) (Amended, SG No. 82/2009, SG No. 28/2011, effective 5.04.2011) When the control ref erred to in Paragraph 1 is exercised, an average sample may be taken from the batch in the presen ce of the producer, the importer, the person placing the product on the market or their representati ves.

(3) (New, SG No. 28/2011, effective 5.04.2011) EC fertilizers shall be tested in laboratories notified in accordance with Article 30 of Regulation (EC) No. 2003/2003. Those laboratories bas ed in the territory of the Republic of Bulgaria which wish to receive approval and be notified in a ccordance with Article 30 of Regulation (EC) No. 2003/2003 shall file an application with the Bu lgarian Food Safety Agency attaching a copy of the accreditation certificate, the scope of which s hould include testing for compliance of the EC fertilizers with Regulation (EC) No. 2003/2003 in terms of their characteristics and methods of testing.

(4) (Renumbered from Paragraph 3, amended, SG No. 28/2011, effective 5.04.2011) The Bu lgarian Food Safety Agency shall notify the list of laboratories in the territory of the Republic of Bulgaria approved within the meaning of Article 30 of Regulation (EC) No. 2003/2003 before the European Commission.

(5) (New, SG No. 28/2011, effective 5.04.2011) In cases of establishing for a lot of fertilizer s, soil improvers, biologically active substances or nutrient substrates that the same have no regist ration, are unfit for use, or do not match the information stated in the accompanying documentati on, or on the label, the inspection authorities of the Bulgarian Food Safety Agency shall stop their sale and use and give instructions for the same:

1. to be taken out of the territory of the country at their holder's expense;

2. to undergo reprocessing by the manufacturer to the extent that the stated characteristics ar e attained;

3. to be destroyed at their holder's expense, if the product is hazardous to human or animal h ealth or the environment.

(6) (New, SG No. 28/2011, effective 5.04.2011) The measures referred to in paragraph 5 sha ll be enforced based on prescriptions, a copy of which shall be handed over to the holder or his or her agent.

(7) (New, SG No. 28/2011, effective 5.04.2011) The individual administrative acts referred t o in paragraph 6 may be appealed against before the Director of the respective Regional Food Saf ety Agency according to the procedure laid down in the Code of Administrative Procedure. The a ppeal shall not suspend the enforcement. (8) (New, SG No. 28/2011, effective 5.04.2011) In cases of establishing a violation and enfo rcing a measure as provided for in paragraph 5, the inspection authorities shall forthwith notify th e Executive Director of the Bulgarian Food Safety Agency whereupon, based on the findings, the Executive Director may issue an order aimed at suspending immediately the placing on the marke t and the use of a particular lot of products while instructing the person who placed it on the mark et to withdraw it from the market not later than one month thereafter. The order shall obligatorily contain an instruction to have the lot taken out of the territory of the country, reprocessed to the e xtent that the stated characteristics are attained or, if it is hazardous to human or animal health or the environment, destroyed in accordance with the Waste Management Act.

(9) (New, SG No. 28/2011, effective 5.04.2011) The order referred to in paragraph 8 may be appealed against according to the procedure laid down in the Code of Administrative Procedure. The appeal shall not suspend the enforcement.

(10) (New, SG No. 28/2011, effective 5.04.2011) Adhering to the deadlines laid down in the acts referred to in paragraphs 5 and 8, the holder or the person who placed the products on the ma rket shall submit written proof of enforcement of the measures to the Bulgarian Food Safety Age ncy.

Article 24f. (1) (Amended, SG No. 28/2011, effective 5.04.2011) The packages, labels and accompanying documents for the products referred to in Article 24a, Paragraph 1 shall bear the fo llowing information in the Bulgarian language:

1. type of the product;

2. mass and volume of the product;

3. conditions for storage;

4. method of application;

5. name and management address of the producer;

6. (Amended, SG No. 28/2011, effective 5.04.2011) name and management address of the p erson placing the product on the market;

7. date of production;

8. expiry date;

9. (New, SG No. 13/2008) a product registration number under Article 24a, Paragraph 2.

(2) The packaging or the labels shall also contain the following information:

1. for all fertilisers - type, trade mark, declared content of nutrient elements in percentages a nd form of the nutrient elements; 2. for organic fertilisers - the information referred to in Paragraph 1, as well as the percentag e content of organic substance and total nitrogen, the origin of the product and the content of hea vy metals;

3. for soil ameliorators - the content of calcium oxide and/or magnesium oxide, or other subs tances improving the physical and mechanic and/or chemical qualities of the soil;

4. for biologically active substances - the active substance, the registered doses for use of the ready product, the crop and the phase of its development when it is applied.

(3) In the case of bulk products, the data referred to in Paragraphs 1 and 2 shall be included i n the accompanying documents.

(4) (Supplemented, SG No. 26/2006, effective 28.03.2006) Liquid fertilizers shall be launch ed on the market accompanied by directions regarding the storage temperature and for prevention of accidents during storage, the date of manufacture and the term of fitness for use.

(5) (Repealed, SG No. 28/2011, effective 5.04.2011)

Article 24g. (1) (Previous text of Article 24g, supplemented, SG No. 28/2011, effective 5.04. 2011) The products referred to in this section shall be stored and transported in observation of the sanitary and hygiene requirements and the requirements for fire and explosion safety in a manner which excludes harm to the health of people, animals and the environment. The manufacturer / i mporter shall be obliged to keep record of the origin of products for the entire period of their bein g placed on the market plus two years thereafter.

(2) (New, SG No. 28/2011, effective 5.04.2011) In cases of placing ammonium nitrate fertili zers of high nitrogen content on the market, each lot thereof shall be accompanied by a detonatio n resistance test certificate issued not earlier than three months ahead of their placing on the mark et. The manufacturer / importer shall be obliged to make the test results available to the Bulgarian Food Safety Agency not later than 5 days ahead of placing the product on the market.

(3) (New, SG No. 28/2011, effective 5.04.2011) No ammonium nitrate fertilizers of high nitr ogen content shall be offered to end users unless packed.

Article 24h. The producers of agricultural production shall be obliged:

1. not to aggravate the agro-chemical status and the fertility of the lands used by them;

2. to keep account of the used quantities and kinds of mineral and organic fertilisers, soil am eliorators and biologically active substances for each field;

3. to ensure the access of the officials carrying out control activities to the lands used by the m;

4. to remove the drainage and rain waters from the covered areas. Chapter Three PHYTO-SANITARY IMPORT AND EXPORT CONTROL Section I Import Control

Article 25. (1) The phyto-sanitary control of plants, plant products or other commodities wh ich are potential carriers of pests shall be organised by the Ministry of Agriculture and Food.

(2) The Minister of Agriculture and Food may prohibit or restrict the import of plants and pl ant products representing a specific risk.

(3) The phyto-sanitary control over the import shall be carried out at the border control point s or at the customs offices, at the points of receiving, processing and storing or during the growin g, production and preparation in the exporting country.

(4) (New, SG No. 96/2001, repealed, SG No. 26/2006, effective 28.03.2006).

(5) (New, SG No. 28/2011, effective 5.04.2011) Phytosanitary control of imports other than at border checkpoints shall be subject to conditions and a procedure laid down in an ordinance iss ued by the Minister of Agriculture and Food.

Article 26. (Amended, SG No. 96/2001, amended and supplemented, SG No. 28/2011, effec tive 5.04.2011) The customs authorities and transporting companies shall not have the right to rel ease, direct or transport plants and plant products which may be carriers of pests without a permit issued by the phytosanitary inspectors of the Bulgarian Food Safety Agency.

Article 27. Any person importing in the country plants, plant products or other commodities which may be carriers of quarantine pests shall be obliged to:

1. declare and submit to phyto-sanitary control the imported plants and products of plant ori gin;

2. (amended, SG No. 96/2001) present a phyto-sanitary certificate from the country where th e plants and the products were produced or a phyto-sanitary certificate of re-export;

3. (amended, SG No. 96/2001) observe the phyto-sanitary requirements determined with the regulation referred to in of Article 12, Paragraph 3.

Article 28. (Supplemented, SG No. 28/2011, effective 5.04.2011) Any import of plants, plan t products or other commodities subject to phyto-sanitary control shall pass through border phyto- sanitary inspection points endorsed by the Minister of Agriculture and Food and set up at border checkpoints established by the Council of Ministers. Article 29. A phyto-sanitary certificate shall not be required and phyto-sanitary control shall not be carried out over the import of plants and plant products when:

1. the import consists of small quantities, has no commercial purpose, bears no phyto-sanitar y risk to the country and is intended for personal consumption of the traveller;

2. the commodities are in transit and the control is only documentary, unless certain country- specific phyto-sanitary requirements require inspection of the cargo.

Article 30. (1) (Amended, SG No. 96/2001) The Minister of Agriculture and Food shall issu e a regulation on the exceptions referred to in Article 5 in connection with conducting of scientifi c research and experiments and referred to in Article 25, Paragraph 2 for import of plants and pla nt products constituting a particular risk.

(2) (New, SG No. 96/2001) The Minister of Agriculture and Food may issue a special permit for import of plants and plant products infected with pests for the exceptions referred to in Paragr aph 1.

(3) (Previous Paragraph (2), amended, SG No. 96/2001) For import referred to in Paragraph 2 the competent state authorities shall carry out periodic inspections at the places where the impor ted commodities have been received.

Article 31. All provisions of this section shall apply to postal parcels. Section II Export Control

Article 32. (1) (Repealed, SG No. 96/2001).

(2) Export phyto-sanitary control shall be carried out by the Bulgarian Food Safety Agency.

(3) Export of plants, plant products or other commodities subject to phyto-sanitary control s hall be carried out only through the border control points determined by the Council of Ministers.

Article 33. (1) (Amended, SG No. 8/2011, effective 25.01.2011) Any exporter of plants and plant products shall be obliged to request from the Ministry of Agriculture and Food a phyto-sanit ary certificate of export or re-export.

(2) (Amended, SG No. 8/2011, effective 25.01.2011, amended, SG No. 28/2011, effective 5. 04.2011) Upon request by exporters of plants and plant products, the Ministry of Agriculture and Food and the Ministry of Health shall issue a certificate of absence of chemical and organic pollu tants.

Article 34. Depending on the findings, after performing control or analysis of the phyto-sani tary condition of the exported commodities, a certificate may be issued, refused or issued upon fu lfilment of the prescriptions given by the state control authorities. Article 35. (1) The export of pests, as well as the export of plants and plant products infecte d by pests or which are prohibited for export shall only be permitted upon preliminary permit by t he Minister of Agriculture and Food if there is written consent by the competent authorities of the importing country.

(2) Permit under Paragraph 1 can be issued only where necessary for scientific research and experimental activity. Chapter Four EQUIPMENT FOR PLANT PROTECTION

Article 36. (Supplemented, SG No. 96/2001, amended, SG No. 28/2011, effective 5.04.201 1) No plant protection equipment shall be placed on the market unless complying with the provisi ons of the Technical Requirements to Products Act and the ordinances on its implementation.

Article 37. (1) (Amended, SG No. 8/2011, effective 25.01.2011) The Minister of Agricultur e and Food, through the specialized administrations under the Agricultural and Forestry Machiner y Registration and Control Act shall:

1. (Supplemented, SG No. 96/2001, amended, SG No. 28/2011, effective 5.04.2011) control the testing and certification of the new plant protection and fertilizing equipment;

2. (repealed, SG No. 96/2001);

5. (Amended and supplemented, SG No. 28/2011, effective 5.04.2011) carry out periodic co ntrol and functional technical inspections of the used plant protection equipment in co-ordination with the Ministry of Health, the Ministry of the Interior and the Ministry of Environment and Wat er.

(2) (Repealed, SG No. 96/2001). Chapter Five ADMINISTRATIVE AND PENAL PROVISIONS

Article 38. Those who cause somebody else's damage by carrying out plant protection meas ures, give wrongful directions and consultations for application of plant protection products, trade and storage, shall owe compensation.

Article 39. (1) (Amended, SG No. 90/1999, SG No. 28/2011, effective 5.04.2011) Where th e act does not constitute a crime, a fine of BGN 1800 to 3600 shall be imposed on a natural perso n:

1. who imports, stores or transports pests on the territory of the Republic of Bulgaria without the necessary permit;

2. who exports plants or plant products without the necessary certificates;

3. who exports pests or plants and plant products infected by pests, or prohibited for export, without the necessary permit;

4. (amended, SG No. 96/2001) who produces or imports with a commercial purpose plants, plant products and other commodities of plant origin without the necessary registration.

5. (new, SG No. 96/2001, amended, SG No. 28/2011, effective 5.04.2011) who places on the market, stores, repackages or uses unauthorized or unfit plant protection products;

6. (new, SG 96/2001, amended, SG No. 28/2011, effective 5.04.2011) who places on the ma rket or uses fertilizers, soil improvers, biologically active substances or nutrient substrates that ar e unregistered, unfit for use, or do not match the information stated in the accompanying docume ntation and/or on the label;

7. (New, SG No. 26/2006, supplemented, SG No. 13/2008, amended, SG No. 28/2011, effec tive 5.04.2011) who places on the market, stores, repackages or uses plant protection products in violation of the requirements of the ordinance under Article 23c;

8. (New, SG No. 13/2008) violates the provisions of the ordinance under Article 23d;

9. (New, SG No. 13/2008, repealed, SG No. 28/2011, effective 5.04.2011)

(2) (Amended, SG No. 90/1999, repealed, SG No. 28/2011, effective 5.04.2011) For the viol ations referred to in Paragraph 1 sole traders and legal persons shall be imposed property sanction s ranging between BGN 2700 and 4800.

Article 39a. (New, SG No. 28/2011, effective 5.04.2011) (1) Unless the act constitutes a cri me, a fine ranging between BGN 1800 and 3600 shall be imposed on any natural person who:

1. has applied the `EC fertilizer' mark to a product which does not comply with the requirem ents of Regulation (EC) No. 2003/2003;

2. has not complied with the obligatory requirement to state the content of nutrients under A rticle 6 of Regulation (EC) No. 2003/2003;

3. has not fulfilled the obligations concerning the maintenance and provision of documentati on on the traceability and origin of fertilizers laid down in Article 8 of Regulation (EC) No. 2003/ 2003;

4. has not complied with the requirements for identification, marking, labeling and packagin g under Articles 7, 9. 10, 11 and 12 of Regulation (EC) No. 2003/2003.

5. has not complied with the requirements concerning the allowable deviations under Article 13 of Regulation (EC) No. 2003/2003;

6. has not complied with the requirements concerning the keeping and provision of records u nder Article 26 of Regulation (EC) No. 2003/2003;

7. has not complied with the requirements laid down in Article 24g (2) and Article 27 of Reg ulation (EC) No. 2003/2003.

8. is in breach of the provisions of Article 24g (3) on mandatory packaging of ammonium nit rate fertilizers.

(2) A fine ranging between BGN 2700 and 4800 shall be imposed on a sole trader or legal p erson for any of the breaches referred to in paragraph 1,

Article 40. (1) (Amended, SG No. 90/1999, SG No. 96/2001, supplemented, SG No. 13/200 8, amended, SG No. 28/2011, effective 5.04.2011) Natural persons who do not fulfil the obligatio ns referred to in Articles 8, 9, 17(1) and (4), 24f, 24h and 26 shall be imposed a fine ranging betw een BGN 1000 and 2400, unless the act constitutes a crime.

(2) (Amended, SG No. 90/1999, SG No. 28/2011, effective 5.04.2011) For the violations ref erred to in Paragraph 1 sole traders and legal persons shall be imposed property sanctions ranging between BGN 1900 and 3600.

Article 41. (1) (Amended, SG No. 90/1999, supplemented, SG No. 96/2001, amended, SG No. 28/2011, effective 5.04.2011) A fine ranging between BGN 1800 and 3600 shall be imposed if the act does not constitute a crime to a natural person who does not comply with the obligatory conditions under Article 7, item 1 or who does not fulfil the prescriptions of the competent bodies under Article 8, Paragraph 2 or under Article 13, or does not fulfil the obligations under Article 2 7.

(2) (Amended, SG No. 90/1999, SG No. 28/2011, effective 5.04.2011) For violations referre d to in Paragraph 1 sole traders and legal persons shall be imposed property sanctions ranging bet ween BGN 2700 and 4800.

Article 41a. (New, SG No. 96/2001, repealed, SG No. 31/2006).

Article 42. (Amended, SG No. 90/1999, SG No. 28/2011, effective 5.04.2011) Physical pers ons shall be imposed a fine ranging between BGN 600 and 1200, if they hinder the fulfilment of t he official duties of the officials referred to in Article 10 and Article 37, Paragraph 1, item 5, unle ss the act constitutes a crime.

Article 42a. (New, SG No. 28/2011, effective 5.04.2011) (1) Unless the act constitutes a cri me, a fine ranging between BGN 1800 and 3600 shall be imposed on any natural person who did not comply with and/or carry out a prescription issued by an inspection authority of the Bulgarian Food Safety Agency in connection with his or her official duties.

(2) Pecuniary sanctions ranging between BGN 2700 and 4800 shall be imposed on sole trade rs and legal persons in the cases of non-compliance referred to in paragraph 1.

Article 43. (1) (Amended, SG No. 90/1999, SG No. 28/2011, effective 5.04.2011) A fine ra nging between BGN 1500 and 2400 shall be imposed on a natural person who advertises a plant p rotection product in violation of the conditions or the prohibition stipulated by Articles 21 and 22, unless the act constitutes a crime.

Article 44 (1) (Amended, SG No. 90/1999, SG No. 13/2008, SG No. 28/2011, effective 5.04. 2011) Unless the act constitutes a crime, a fine ranging between BGN 1500 and 4800 shall be im posed on any natural person who places on the market, stores and repackages plant protection pro ducts intended for sale without relevant permit or who carries out fumigation and decontaminatio n of areas, premises and plant products for the purpose of pest control without relevant permit.

Article 44a. (New, SG No. 28/2011, effective 5.04.2011) (1) Unless the act constitutes a cri me, a fine ranging between BGN 500 and 1000 shall be imposed on any natural person who tests unauthorized plant protection products for the purpose of research and experiment without releva nt permit under Article 16a (1).

(2) Pecuniary sanctions ranging between BGN 1000 and 2000 shall be imposed on sole trade rs and legal persons in the cases of non-compliance referred to in paragraph 1

Article 45. (1) (Amended, SG No. 90/1999, SG No. 96/2001, SG No. 28/2011, effective 5.0 4.2011) Officials who have not fulfilled their duties referred to in Article 12, Paragraph 2 and 4 a nd Article 26 shall be imposed a fine ranging between BGN 600 and 1600.

Article 46. If the violation is repeated within one year, the fine or the property sanction shall be doubled.

Article 46a. (New, SG No. 28/2011, effective 5.04.2011) A fine ranging between BGN 100 and 500 and a pecuniary sanction ranging between BGN 500 and 1000 shall be imposed on natur al persons and sole traders and legal entities, respectively, found to be responsible for breaches of this Act other than those listed in this Chapter. Article 46b. (New, SG No. 28/2011, effective 5.04.2011) A fine ranging between BGN 50 a nd 250 and a pecuniary sanction ranging between BGN 250 and 750 shall be imposed on natural persons and sole traders and legal entities, respectively, found to be responsible for breaching the ordinances and other statutory acts on the implementation of this Act and not liable to sanctions u nder the provisions of this Chapter.

Article 47. (1) (Amended, SG No. 8/2011, effective 25.01.2011) The statements establishin g the violations referred to in this Act shall be issued by the relevant control authorities of the Bul garian Food Safety Agency and by its divisions in the country, while the penalty decrees shall be issued by the directors of the relevant regional food safety directorates.

(2) The establishment of violations, the issuance, the contestation and the enforcement of the penalty decrees shall be carried out pursuant to the procedure of the Administrative Violations an d Sanctions Act. SUPPLEMENTARY PROVISIONS

§ 1. Within the meaning of this Act:

1(Amended, SG No. 96/2001) "Phyto-sanitary control" shall mean the control aimed at the p revention of the transfer across the state border and the spread of pests on plants and plant produc ts.

2. "Phyto-sanitary certificate" shall mean an official international document complying with the model attached to the International Convention for Plants Protection (Rome, 1951) certifying the absence of quarantine pests in the batch.

3. "Phyto-sanitary passport" shall mean an official label issued by a European Union membe r state showing that the European provisions regarding the phyto-sanitary norms, as well as all ot her specific requirements, have been complied with and which, in this case shall be:

a) standard for the European Union countries for the various types of plants or plant product s;

b) approved by the official authorities of the member states and issued in compliance with th e requirements for application and with the particularities of the procedure for issuance of a phyt o-sanitary passport.

4. "Plants" shall mean live plants or live parts of them, including seeds; live parts of plants s hall be: fruits in the botanical sense without bulbs, tubers, roots, cut blossoms, branches and leave s, cut trees, parts of them and leaves, and tissues preserved through deep freezing.

5. "Seeds" shall mean seeds in botanical sense intended for sowing.

6. "Plants for planting" shall mean those which are planted and will remain such or which sh all be planted after their import, or plants which have not been planted at the time of their import but which will be planted after that.

7. "Planting" shall mean any operation related to placing the plants in conditions providing t heir further growth, reproduction and multiplication.

8. (Amended, SG No. 96/2001) "Plant products" shall mean products of plant origin non-pro cessed in a factory (including grain), as well as the processed products, which with regard to their nature or their change can be a risk for introduction or for dissemination of the risk.

9. "Nutrient medium" shall mean every material in which the plants develop roots or which i s designated for this purpose.

10. "Timber" shall mean material without or with bark in the form of trunks, beans, plates, w aste from wood processing, isolated bark, as well as in the form of auxiliary and flooring material and wrapping.

11.(Amended, SG No. 96/2001) "Quarantine pest" shall mean a pest who has potential impo rtance for the economy of the threatened zone and has not yet been introduced in this zone or is al ready in it, but is not widely disseminated and it is site of official control.

12. (Amended, SG No. 96/2001) "Pest" shall mean each plant or animal species, gender, bi o-type or pathogenic agent, harmful to the plants or the plant products.

13. "Integrated control" shall mean the rational implementation of a combination of biologic al, biotechnological, chemical, physical and agrotechnical measures or measures related to the sel ection of plants, whereas the use of plant protection products is reduced to a strict minimum with the purpose of maintaining the population of pests under the threshold of economical harm.

14. (Amended, SG No. 96/2001) "Preparations" shall mean mixtures of solvents containing t wo or more substances of which at least one is active, intended for use as plant protection product s.

15. (Amended, SG No. 96/2001, 26/2006, effective 28.03.2006) "Plant protection products" shall mean active substances and products containing one or several active substances which are s upplied to the users and are intended to:

a) protect plants or plant products from pests or to protect from the impact of pests;

b) influence the life processes of the plants in a manner, different from that of foodstuffs;

c) protect plant products, but are not preservatives;

d) exterminate undesirable plants;

e) destroy parts of plants; f) control and inhibit undesirable growth of plants;

Plant protection products shall be sub-divided into:

a) insecticides - preparations for control of harmful species of insects; insecticides may be a pplied for:

aa) vegetation treatments;

bb) treatment in cultivation facilities;

cc) fumigation and decontamination of empty premises and warehoused produce, against wa rehouse pests;

dd) treatment and fumigation of soil;

b) acaricides - preparations for control of acarides;

c) nematocides - preparations for control of nematodes;

d) limacides - preparations for control of snails;

e) rodenticides - preparations for control of rodents;

f) attractants - preparations, attracting undesirable insects to certain locations.

g) repellents - preparations, repelling undesirable insects, rodents, birds and other plant pests;

h) fungicides - preparations for protection and control of agents of plant diseases; fungicides may be used for:

aa) vegetation treatments;

bb) treatment of seeds;

cc) treatment in the course of storage of plant produce;

i) herbicides - preparations for control of weeds;

j) defoliants - preparations used to eliminate plant leaves;

k) desiccants - preparations used to dry plants;

l) growth regulators - preparations used to regulate physiological processes in plants.

16. "Plant protection services" shall mean a paid activity related to the plant protection meas ures and activities. 17. (New, SG No. 96/2001) "Biological agent" shall mean a biological unit able to reproduc e itself, which is used for control of harmful organisms.

18. (New, SG No. 96/2001) "Fertiliser" shall mean a material whose main function is to sup ply plants with nutrient substances.

19. (New, SG No. 96/2001) "Mineral fertilisers" shall mean fertilisers in which the announc ed nutrient elements are in the form of non-organic salts obtained as non-mined resources and/or by chemical process.

20. (New, SG No. 96/2001) "Organic fertilisers" shall mean carbon containing products of mainly plant and/or animal origin which are added to the soil for nutrition of the plants.

21. (New, SG No. 96/2001) "Soil ameliorators (meliorants)" shall mean materials, which are added to the soils, whose main function is to improve the physical and/or the chemical properties and/or the biological activity of the soils.

22. (New, SG No. 96/2001) "Biologically active substances" shall mean growth substances f ormed in small quantities in the very plants and/or products of chemical synthesis, stimulating or suppressing the physiological processes, substantiating the growth and the development of the pla nts, which do not contain nutrient elements

23. (New, SG No. 96/2001) "Nutrient substrates" shall mean products, the use of which ensu res a crumbly environment for the plants, fostering their absorbing organs and ensuring the nutrie nt substances necessary for their growth and development.

24. (New, SG No. 96/2001) "Fertility of the soil" shall mean the ability of the soil to create c onditions for development of the plants as well as to supply them during the whole vegetation per iod with the necessary quantities of assimilative nutrient substances and water.

25. (New, SG No. 96/2001, amended, SG No. 28/2011, effective 5.04.2011) "Formulation of plant protection products" shall mean a combination of different components making the product useful and efficient for the required purpose; the form of the plant protection product in which it i s placed on the market.

26. (New, SG No. 96/2001) "Active substances" shall mean substances or micro-organisms, including viruses, which have general or specific impact against pests or over the plants, parts of t he plants or the plant products.

27. (New, SG No. 96/2001) "Pollutant" shall mean a substance which is contained in the pla nt raw materials as result of the activities and the preservation thereof or in the soil and the waters as result of pollution of the environment.

28. (New, SG No. 96/2001) "Permission for a plant protection product" shall mean an admin istrative act issued by a competent state authority upon an application submitted for placing on th e market of a plant protection product on the territory of the country. 29. (New, SG No. 96/2001) "Environment" shall mean the waters, the air, the soils, the wild species of the flora and the fauna, the interaction between them and their relation to the living org anisms.

30. (New, SG No. 96/2001, amended, SG No. 8/2011, effective 25.01.2011) "Organic produ ction of plants, plant products and foods of plant origin" shall mean a method of production in wh ich a system of strictly defined methods and specific rules for control are applied, determined in a regulation issued by the Minister of Agriculture and Food.

31. (New, SG No. 26/2006, effective 28.03.2006) "Existing active substance" shall mean an active substance, which was on the market of the European Union prior to 25 July 1993.

32. (New, SG No. 26/2006, amended, SG No. 28/2011, effective 5.04.2011) "New active su bstance" shall mean an active substance, which was placed on the market of the European Union after 25 July 1993.

33. (New, SG No. 26/2006, effective 28.03.2006) "Notified existing active substance" shall mean an existing active substance, for which an application was submitted by one or more applic ants for inclusion into the list of active substances, permitted in the European Union.

34. (New, SG No. 26/2006, effective 28.03.2006) "Notified new active substance" shall mea n a new active substance, for which an application was submitted by one or more applicants for i nclusion into the list of active substances, permitted in the

European Union and in regard to which the European Commission has ruled that the docum entation submitted was sufficiently complete.

35. (New, SG No. 26/2006, amended, SG No. 28/2011, effective 5.04.2011) "Parallel trade i n plant protection products" shall mean placing on the market in the Republic of Bulgaria of a pla nt protection product, identical to the plant protection product, already authorized in this country.

36. (New, SG No. 26/2006, amended, SG No. 8/2011, effective 25.01.2011, supplemented, SG No. 28/2011, effective 5.04.2011) "Approved facilities of natural and legal persons shall mea n the officially approved facilities, having personnel, premises, equipment and apparatuses, requir ed to conduct testing of plant protection products and which have received from the Bulgarian Fo od Safety Agency certificates for ensuring the quality, required by Good Experimental Practice a nd Good Laboratory Practice.

37. (New, SG No. 26/2006, amended, SG No. 28/2011, effective 5.04.2011) "Re-packaging" shall mean a transfer of the contents of one package into another, usually smaller one, intended fo r placing on the market, which has been permitted by the product manufacturer or its authorized r epresentative.

38. (New, SG No. 26/2006, amended, SG No. 28/2011, effective 5.04.2011) "Generic plant protection product" shall mean a plant protection product in regard to which an application for au thorization was issued, which contains an active substance whose producer applied or was involv ed in the process of applying for its inclusion in the list of active substances authorized in the Eur opean Union.

39. (New, SG No. 26/2006, effective 28.03.2006). "Letter for access to protected data" shall mean a document, signed by the owner(-s) of information, protected as confidential, evidencing t hat the competent bodies of the Republic of Bulgaria may use it also for authorizing another prod uct, different from the original one.

40. (New, SG No. 26/2006, amended, SG No. 28/2011, effective 5.04.2011) . "Placing on th e market" shall mean each delivery, regardless of whether for payment or for free, which is not in tended for warehousing, followed by shipment outside the territory of the Republic of Bulgaria. S torage pending delivery shall be treated as placing on the market. Import into the territory of the Republic of Bulgaria shall be treated as placing on the market.

41. (New, SG No. 26/2006, amended, SG No. 8/2011, effective 25.01.2011, supplemented, SG No. 28/2011, effective 5.04.2011) "Official testing facilities of the Bulgarian Food Safety Ag ency" shall mean facilities of the Bulgarian Food Safety Agency, which conduct tests of plant pro tection products, in compliance with the principles of Good Experimental Practice and Good Lab oratory Practice.

42. (New, SG No. 26/2006, effective 28.03.2006) "Applicant" shall mean a manufacturer of plant protection products, or its representative, authorized in writing. The manufacturer of plant p rotection products shall be the holder of the certificate for authorization.

43. (New, SG No. 26/2006, supplemented, SG No. 28/2011, effective 5.04.2011) "Minimal use" shall mean the use of an authorized plant protection product against rare pests on farm crops cultivated seldom and by a limited number of producers or widely cultivated crops which require using the product in response to an extraordinary necessity.

44. (New, SG No. 26/2006, effective 28.03.2006) "Economically important agricultural pest s" shall denote diseases, pests and weeds, which appear annually and cause substantial losses of f arm produce.

45. (New, SG No. 26/2006, effective 28.03.2006) "Good Laboratory Practice" shall mean a quality system, related to the organizational process as well as to the conditions in which the out- of-clinic studies of the safety of plant protection products for the human health and the environme nt are planned, conducted, controlled, documented, stored and reported.

46. (New, SG No. 26/2006, effective 28.03.2006) "Good Plant Protection Practice" shall me an a combination of rules in the course of performing the plant protection activities.

47. (New, SG No. 26/2006, amended, SG No. 8/2011, effective 25.01.2011) "Signalisation f or economically important agricultural pests" shall mean the designation and announcement by th e Bulgarian Food Safety Agency to interested consumers of the optimal terms for conducting pla nt protection activities in order to protect against an attack or against pests, which had reached the economic threshold of harmfulness. 48. (New, SG No. 26/2006, effective 28.03.2006) "Integrated production" shall mean produc tion of plants and plant raw materials under regulated rules, in order to achieve a certain quality, where priority shall be accorded to environment-friendly methods for minimizing the negative sid e effects of the plant protection products applied on ensuring safety of the producer and consumer s and environment protection.

49. (New, SG No. 26/2006, effective 28.03.2006) "Authorization of additional uses" shall m ean authorization of a new use of an already authorized plant protection product in this country.

50. (New, SG No. 26/2006, effective 28.03.2006) "Effectiveness of plant protection product s" shall mean the ratio between the positive and negative effects of the application of plant protec tion products, where positive effects must be greater than the negative effects, which may occur f or the environment or the yield of the respective crop, as a result of the application or non-applica tion of plant protection products.

51. (New, SG No. 26/2006, repealed, SG No. 13/2008).

52. (New, SG No. 8/2011, effective 25.01.2011) "Border inspection phytosanitary points" sh all be special self-contained areas in the area of the border checkpoint intended for the performan ce of phytosanitary control.

53. (New, SG No. 28/2011, effective 5.04.2011) "Ammonium nitrate fertilizers of high nitro gen content" shall mean simple or complex ammonium nitrate based fertilizers containing more t han 28 percent of nitrogen by weight of fertilizer in relation to the ammonium nitrate.

54. (New, SG No. 28/2011, effective 5.04.2011) "Good Experimental Practice" shall mean a system of basic rules for organizing field trials which ensures that the conduct, reporting, recordi ng, assessment and analysis of trials be performed so that the results thereof are in conformity wit h the provisions of Guidelines 181 and 152 of the European and Mediterranean Plant Protection Organization (EPPO).

55. (New, SG No. 28/2011, effective 5.04.2011) "Equivalence" shall mean the determination of the similarity of the chemical composition presented by different sources of technical materials. If the new source presents a similar or lesser hazard compared to the reference source, the new s ource can be considered equivalent to the reference source.

56. (New, SG No. 28/2011, effective 5.04.2011) "Co-formulant" shall mean an inactive com pound other than the active substance, as incorporated in a plant protection product.

57. (New, SG No. 28/2011, effective 5.04.2011) "Unfit plant protection products and fertiliz ers" shall mean products whose shelf life has expired and/or products with deteriorated physical a nd chemical properties.

58. (New, SG No. 28/2011, effective 5.04.2011) Within the meaning of Chapter 2, Section V, "Lot" shall denote a certain amount of fertilizers, soil improvers, biologically active substance s or nutrient substrates, packaged or in bulk, uniform as concerns their type, composition, quality, name, place of origin and person responsible for packaging thereof and accompanied by the same shipment document or quality certificate.

59. (New, SG No. 28/2011, effective 5.04.2011) "Environmental behavior of a plant protecti on product" shall mean the impact of the product on the environmental media and the possibility f or the same to enter the soil, contaminate any surface and groundwater or spread in the air under conditions of actual use.

60. (New, SG No. 28/2011, effective 5.04.2011) "Retail trade in plant protection products" s hall mean all activities involving procurement, delivery, keeping in stock for the purpose of sellin g or sale of plant protection products to end users.

61. (New, SG No. 28/2011, effective 5.04.2011) "Wholesale trade in plant protection produc ts" shall mean all activities involving sale and purchase, acquisition, import, delivery, storage, pro curement or export of plant protection products other than retail trade in plant protection products.

62. (New, SG No. 28/2011, effective 5.04.2011) "Phyto-sanitary inspectors" shall mean exp erts possessing the necessary qualifications and appointed to carry out phyto-sanitary control.

63. (New, SG No. 28/2011, effective 5.04.2011) "Fumigation" is a method of pest extermina tion based on the utilization of gases within hermetically sealed spaces. FINAL PROVISIONS

§ 2. This Act shall repeal the Protection of Plants from Diseases and Pests Act (Promulgated, Transactions No 11/1960; amended, SG, No 26 of 1968).

§ 3. The Minister of Agriculture and Food shall issue regulations for the implementation of t his Act.

§ 4. The implementation of this Act is assigned to the Minister of Agriculture and Food.

CONCLUDING PROVISIONS of the Act Amending and Supplementing the Plant Protectio n Act

(SG No. 96 of 2001)

§ 44. Everywhere in the text of the Act the words "the Ministry of Agriculture, Forests and Agrarian Reform", "the Minister of Agriculture, Forests and Agrarian Reform" and "the Minister of Agriculture, Forests and Agrarian Reform" shall be replaced respectively by "the Ministry of Agriculture and Forestry", "the Minister of Agriculture and Forestry" and "Minister of Agricultur e and Forestry".

§ 45. Everywhere in the text of the Act the words "the National Office for Plant Protection, Quarantine and Agrochemistry" shall be replaced by the words "the National Service for Plant Pr otection". § 46. Everywhere in the text of the Act the words "phyto-pharmaceutical preparation", "phyt o-pharmaceutical preparations" and "the phyto-pharmaceutical preparations" shall be replaced res pectively by "plant protection product", "plant protection products" and "the plant protection prod ucts".

TRANSITIONAL AND CONCLUDING PROVISIONS of the Act Amending and Supplem enting the Plant Protection Act

(SG No. 26/2006, effective 28.03.2006)

§ 30. The Ordinance under Article 14(5) shall be issued within one month of entry of this Ac t into force.

§ 31. Plant protection products, authorized in the Republic of Bulgaria prior to the entry of t his Act into force, may be imported into this country until 1 June 2006, if the active substances, c ontained therein, have been included in:

1. in the list, approved by special order, of active substances, prohibited for inclusion during production of plant protection products and for which the prohibitive condition shall enter into eff ect as of 1 January 2007, or

2. in the list under Article 15(1) item 2 or which were not notified.

§ 32. Plant protection products, which have valid authorizations as at the date of entry of this Act into force and their active substances were not included into the list under Article 15(1) item 1 and by that date no decision exists for their non-inclusion into it, shall retain their authorization s until the date of their expiry and/or of the decision on inclusion or non-inclusion of their active substances into the list under Article 15(1) item 1.

§ 33. This Act shall enter into force as of the date of its publication in State Gazette, except f or § 7 - in regard to Article 14a and § 13 - in regard to Article 15g, which shall enter into force as of 1.01.2008.

TRANSITIONAL AND FINAL PROVISIONS to the Common Organisations of Markets in Agricultural Products of the European Union Implementing Act

(SG, No. 96/2006, effective 1.01.2007)

§ 2. The Ministry of Agriculture and Forestry shall exercise controls on the conformity of ag ricultural products and foodstuffs with traditional specific character or protected geographical ind ication under Article 18 until control bodies have been granted authorisations according to the pr ocedure laid down in Articles 19 and 20.

§ 3. (1) In the case of amending or repealing any regulation referred to in this Act, the provis ions of this Act shall apply according to the regulation or the regulations that amend or replace it.

(2) Where regulations on the implementation of any regulation referred to in this Act have b een adopted, the latter shall be applied according to these implementing regulations.

§ 4. (1) The ordinances issued on the basis of the provisions repealed by § 8, item 1 of § 9, a nd item 2 of § 10, as well as the ordinance provided for in Article 7e and 7g of the Agricultural Pr oducers Support Act repealed by item 1 of § 5, shall remain in force until the relevant ordinances provided for in this Act have been adopted.

(2) Any approvals and authorisations granted on the basis of the provisions repealed by item 1 of § 5, § 8, and item 1 of § 9 shall remain in force until expiration of their term of validity.

TRANSITIONAL AND FINAL PROVISIONS

to the Act amending and supplementing the Fisheries and Aquaculture Act

(SG No. 36/2008)

......

§ 58. Everywhere in the Plant Protection Act (Promulgated SG. 91/1997, amended, SG. 90/1 999, amended and supplemented, SG. 96/2001, supplemented, SG. 18/2004, effective 6.04.2004, amended and supplemented, SG No. 26/2006, effective 28.03.2006, amended, SG No. 31/2006, a mended, SG No. 96/2006, amended and supplemented, SG No. 13/2008) the words "The Ministr y of Agriculture and Forestry", "the minister of agriculture and forestry" and "minister of agricult ure and forestry" shall be replaced by "The Ministry of Agriculture and Food Supply", "the minist er of agriculture and food supply" and "minister of agriculture and food supply".

......

TRANSITIONAL AND FINAL PROVISIONS to the Bulgarian Food Safety Agency Act

(SG No. 8/2011, effective 25.01.2011)

§ 1. (1) The Bulgarian Food safety Agency shall be the legal successor of the assets, liabiliti es, records, rights and obligations of the National Veterinary Service, excluding the Plant Protecti on Institute.

(2) The Bulgarian Food safety Agency shall be the legal successor of the respective part of t he assets, liabilities, records, rights and obligations of the National Grain and Feed Service, the re gional health inspectorates and the regional agriculture directorates that is relevant to the operatio ns of the BFSA under Article 3(1).

(3) The employment relationships of employees of the authorities under Paragraphs 1 and 2 shall be settled as per the procedures laid down in Article 123 of the Labour Code and in Article 87a of the Civil Servant Act.

(4) The property of the National Grain and Feed Service used to carry out activities related t o controls over feedingstuffs and the property of the Central Laboratory for the Quality of Grain, Grain Products and Feedingstuffs shall be transferred to the BFSA by an order of the Minister of Agriculture and Food.

(5) The chattel of the regional agriculture directorates used to carry out activities related to q uality controls over fresh fruit and vegetables shall be transferred to the BFSA by an order of the Minister of Agriculture and Food.

(6) The chattel of the regional health inspectorates used for the purposes of food controls, ex cluding controls of bottled natural mineral waters, spring waters and drinkable natural waters, sha ll be transferred to the BFSA by an order of the Minister of Agriculture and Food.

§ 2. (1) Any certificates, authorisations, licences and other documents issued prior to the entr y into force of this Act by the National Veterinary Service, the National Plant Protection Service, the National Grain and Feed Service, the regional agriculture directorates, as well as those issued by the Minister of Health and by the regional health inspectorates in relation to the operations of t he BFSA under Article 3(1) shall retain their validity within the period they have been issued for.

(2) Any procedures for the issuance of documents under Paragraph 1 that had started prior to the entry into force of this Act shall be completed as per the grandfathering procedure by the exec utive director of the FSA or by the directors of regional food safety directorates, respectively, acc ording to the powers laid down in this Act.

......

§ 23. The Plant Protection Act (promulgated, SG No 91 of 1997; amended, SG No 90 of 199 9, No 96 of 2001, No 18 of 2004, Nos 26, 30, 31 and 96 of 2006, Nos 13, 36 and 43 of 2008 and No 82 of 2009) shall be amended and supplemented as follows:

......

32. Throughout the Act:

a) "National Service for Plant Protection" shall be replaced by "Bulgarian Food Safety Agen cy";

b) "food supply" shall be replaced by "food", and "regional plant protection service" shall be replaced by "regional food safety directorate".

Act to Amend and Supplement the Plant Protection Act

(SG No. 28/2011, effective 5.04.2011

§ 53. The words "offering at the market", "the offering at the market" and "offer" shall be re placed by "placing on the market", "the placing on the market" and "place", respectively, elsewhe re in this Act.