Name of law law of the Center for risk assessment on food chain Named Bill Bill for risk assessment on food chain accepting date 26/05/2016 number/year Official Gazette 44/2016 Decree No 167
On the grounds of art. 98, paragraph 4 of the Constitution of the Republic of Bulgaria
I DECLARE:
To be published in the Official Gazette the law for the Centre for risk assessment on food chain, adopted by HLIÌI National Assembly on 26 May 2016.
Issued in Sofia on June 6, 2016.
The President of the Republic: Rosen Plevneliev
Stamped with the State seal.
Minister of Justice: Catherine Dana
LAW
about the Centre for risk assessment in food chain
Chapter one
GENERAL
Art. 1. (1) the law regulates the structure and activity of the Centre for the evaluation of risk on the food chain and the competence of its bodies.
(2) the Centre for risk assessment in the food chain (CORHV) is a legal person the budgetary allowance – secondary authorising officer with a budget to the Minister of agriculture and food, based in Sofia.
Art. 2. (1) the Centre for risk assessment on food chain e: 1. a competent authority within the meaning of art. 22 (7) of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the General principles and requirements of food law, establishing the European food safety authority and laying down procedures in matters of food safety, hereinafter referred to as "Commission Regulation (EC) No 178/2002";
2. Organization in the network of organisations operating in the fields within the competence of the European food safety authority (EFSA) in accordance with art. 36 of Regulation (EC) No 178/2002;
3. jurisdiction and coordinating authority within the meaning of art. 75 (1) and (2) under Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC of the Council (OJ L 303/1 of 24 November 2009), hereinafter referred to as "Commission Regulation (EC) No 1107/2009" in the procedures for the approval, renewal and review of the approval of active substances, safeners and synergists;
4. a competent authority within the meaning of art. 75 (1) of Regulation (EC) No 1107/2009 for an assessment with an evaluation report on the authorisation, renewal, modification and withdrawal of authorisation for placing on the market and use of plant protection products on the market.
(2) the Centre for risk assessment on food chain interacts with the EFSA, with other European and international organisations and with the competent authorities in the field of the food chain to the other countries.
Chapter two
ACTIVITIES OF CENTRE FOR RISK ASSESSMENT IN FOOD CHAIN
Section I
Risk assessment in food chain
Art. 3. (1) the Centre for risk assessment in the food chain:
1. carry out scientific risk assessment by an independent, transparent and unbiased analysis of scientific information on issues which directly or indirectly affect the health of animals and plants, plant products and plant reproductive material and the safety of food and feed;
2. collect data, including from outside the Ministry of agriculture and food structures necessary for the risk assessment of the food chain; where necessary for the purposes of the risk assessment carried out research and collect information on the ground;
3. the competent authorities and institutions which serve scientific assessments to make decisions to manage risks in the food chain;
4. in connection with the established by the it risks giving suggestions and recommendations on the training of:
and employees of the institutions), which carried out the State policy in the field of the food chain;
(b)) the employees of the bodies which shall carry out official controls under Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules, hereinafter referred to as "Commission Regulation (EC) No 882/2004;
in) the persons to whom they have delegated tasks related to official controls in accordance with art. 5 of Regulation (EC) No 882/2004.
(2) the assessment of risk in the food chain under para. 1.1 's naučnoobosnovan process in accordance with Regulation (EC) No 178/2002 and shall be carried out under conditions and by an order determined by the Ordinance of the Council of Ministers.
(3) the collection of the data referred to in para. 1, item 2 and providing a guest under para. 1, item 3 shall be determined by the Ordinance under para. 2.
(4) to perform services related to the activities of CORHV, outside those under art. 6, al. 4, art. 7, para. 2 and art. 10, para. 2, is payable on the price list approved by the Director of CORHV, which is published on the website of CORHV.
Art. 4. (1) on the basis of the data referred to in art. 3, al. 1 2 CORHV carries out scientific risk assessment of the food chain in terms of:
1. the safety of the food chain;
2. human health associated with foods and zoonoses;
3. animal health and welfare;
4. the use of veterinary medicinal products;
5. the health of the plants, plant products and plant reproductive material;
6. active substances, plant protection products and fertilisers;
7. genetically modified food and feed and novel foods;
8. the animal by-products and derived products.
(2) the scientific assessment under paragraph 1. 1, item 2 shall submit to the Ministry of health.
Art. 5. the data referred to in art. 3, al. 1, item 2 shall be used for the aggregation and analysis of relevant scientific and technical information about: 1. food consumption and the exposure of individuals to risks related to the consumption of food;
2. animal health;
3. the use of feed;
4. pathogenic agents causing animal diseases, zoonoses and food blasts;
5. the health of the plants, plant products and plant reproductive material;
6. the mechanical, chemical and biological contaminants, veterinary medicinal products and their residues in food and feed;
7. materials and articles intended to come into contact with food enzymes and flavourings;
8. plant protection products and fertilisers;
9. dietetic products, nutrition and allergens;
10. food additives and food additives;
11. genetically modified food and feed and novel foods;
12. the radiation risk to animals and plants;
13. animal by-products and derived products;
14. biocidal products in accordance with annex V of Regulation (EC) No 528/2012 to the European Parliament and of the Council of 22 may 2012 on the market and use of biocidal products (OJ L 167/1 of 27 June 2012), used in the production and marketing of foods, with the exception of those by product type 1, 2, 9, 10 and 13.
Art. 6. (1) to carry out a scientific assessment of risk in the food chain: CORHV
1. maintain and store databases with information on art. 4 and 5;
2. carry out analysis of emerging risks in the food chain;
3. study the information needs necessary for carrying out an objective assessment of risk;
4. communication and the exchange of information with all the institutions and persons concerned with the safety of the food chain;
5. analyze and draw:
(a) by 30 June each year) report to:
AA) the European food safety authority on the results of laboratory studies and studies on zoonoses, zoonotic agents, microbial resistance and food infections, remnants of chemical and biological pollutants, plant protection products and veterinary medicinal products, and other information related to risks in the food chain;
BB) Prime Minister, the Minister of agriculture and forests, the Minister of health and the Executive Director of the Bulgarian Agency for food safety (BABH) and, if necessary, to other agencies and organizations that are relevant to the safety of the food chain, in connection with the distribution, occurrence or danger of penetration of the territory of the country of the risks associated with the food chain;
(b)) reports to the authorities and bodies referred to in (a) in an emergency or imminent danger of penetration of the territory of the country of the risks associated with the food chain;
in additional information) when doubts about the advent of high risk associated with animal and plant health, plant reproductive material and the safety of food and feed; the information is sent immediately to EFSA under art. 34 of Regulation (EC) No 178/2002;
6. analyze data from information systems of the European Union relating to the food chain;
7. promotes the activities of EFSA by the contact centre under art. 21;
8. participate in the projects of the EFSA and in projects in other international organizations;
9. maintain a database of national research organisations working in areas related to the safety of the food chain, for the exchange of scientific information and cooperation by agreement with the organizations.
(2) the report referred to in paragraph 1. 1, item 5, letter "a", "AA" subparagraph be made available to the Ministry of health.
(3) scientific assessments can be carried out by the CORHV on its own initiative or at the written assignment by institutions and individuals.
(4) For the assigned fee assessments on tariff approved by the Council of Ministers. When scientific assessments are assigned by the structures of the Ministry of agriculture and food or by the Ministry of health, no fee will be charged.
(5) the award of scientific assessments institutions or persons referred to in para. 3 provide the CORHV all available information, the results of laboratory tests and documents relating to the request for assessment.
(6) where it is not provided with all available information under para. 5 or when the request is unclear, may CORHV to reject the request for a reasoned estimate or to propose amendments to a request, after consultation with the institutions or persons referred to in para. 3.
(7) in the course of its business CORHV may assign the preparation of scientific assessments of the risks in the food chain and external experts.
(8) persons who carry out the scientific assessment, sign a declaration of confidentiality in a form approved by the Director of the CORHV, with which they undertake not to disclose the information and not to use it for its own benefit or for the benefit of third parties.
(9) scientific evaluations are published on the website of CORHV.
Section Ii
The approval, renewal and review of the approval of active substances, safeners and synergists and evaluation of plant protection products on the market
Art. 7. (1) the Centre for risk assessment on food chain activities carried out by the approval, renewal and review of the approval of active substances, safeners and synergists in accordance with Regulation (EC) No 1107/2009.
(2) for the Al. 1 shall be payable under tariff fees under art. 6, al. 4.
Art. 8. (1) the Centre for risk assessment on food chain evaluation with an evaluation report pursuant to Regulation (EC) No 1107/2009 for:
1. plant protection products to solve them for placing on the market and use, renewal, amendment and revocation of authorisation for placing on the market and use, for expanding the scope of the authorisation for placing on the market and use of plant protection products for minor uses and for mutual recognition of authorisations of products;
2. identity of the plant protection products with their parallel trade;
3. for plant protection products containing candidates for substitution substances.
(2) the Centre for risk assessment on food chain carries out other assessments in accordance with Regulation (EC) No 1107/2009 and the Ordinance under art. 45, para. 1 of the law for the protection of plants.
Art. 9. (1) the Guest under art. 8 cover:
1. identity, equivalence, physical, chemical and technical properties and analytical methods of active substances and plant protection products;
2. the toxicological characteristics of active substances and plant protection products;
3. the residues of plant protection products on the market;
4. the existence and behaviour in the environment of active substances and plant protection products;
5. ecotoxicological characteristics of active substances and plant protection products;
6. biological characteristics of plant protection products on the market.
(2) for the conduct of the evaluations referred to in para. 1 apply the Ordinance under art. 45, para. 1 of the law for the protection of plants.
(3) persons who carry out reviews under paragraph 1. 1, sign a declaration of confidentiality in a form approved by the Director of the CORHV, with which they undertake not to disclose the information and not to use it for its own benefit or for the benefit of third parties.
Art. 10. (1) the Guest ratings reports shall be transmitted to the BABH within the following time-limits:
1. in resolution and amendment of the authorisation for placing on the market and use of plant protection product – no later than 45 days before the expiry of the time limit for the completion of the procedure;
2. upon renewal of the authorisation for placing on the market and use of plant protection product – no later than 45 days before the expiry of the time limit for the completion of the procedure;
3. the extension of the scope of the authorisation for placing on the market and use of plant protection products for minor use – not later than 45 days before the expiry of the time limit for the completion of the procedure;
4. When authorising the placing on the market and use of plant protection products for parallel trade – no later than 10 days before the expiry of the time limit for the completion of the procedure;
5. in the mutual recognition of authorisations for the placing on the market and use of plant protection products on the market – not later than 45 days before the expiry of the time limit for the completion of the procedure;
6. Apart from the cases referred to in items 1 – 5 – not later than 14 days before the expiry of the time limit for the completion of the procedure.
(2) For the assessment of the evaluation report fee according to the tariff referred to in art. 6, al. 4. (3) the time limits referred to in para. 1 starting from the receipt of the document for paid fee and copies of the documents required under art. 46, para. 4 of the law on protection of plants.
(4) where the fee is not paid in time, the procedure shall be suspended and shall notify in writing CORHV BABH.
Art. 11. (1) when the assessment with the assessment report additional information needed, notify in writing the person CORHV and sets the deadline for its submission, which may not be longer than six months.
(2) pending the submission of the information referred to in para. 1 deadline for completion of the assessment.
(3) the circumstances referred to in para. 1 and 2 and for failure to submit information within the time limit referred to in paragraph 1. 1 CORHV notify BABH.
Art. 12. where appropriate, the CORHV may have carried out the evaluations with evaluation reports on art. 7 and 8 and to outside experts.
Section Iii
Training
Art. 13. the institutions and bodies referred to in article 1. 3, al. 1, item 4 shall draw up in accordance with annex II of Regulation (EC) No 882/2004 and annex I, section III, chapter IV of Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption, annual training programs :
1. employees, performing official controls; These employees are trained and in the administration of activities under official control in accordance with the level of their competence;
2. the persons to whom they have delegated tasks related to official controls – in accordance with the specific nature of the activities carried out;
3. the officials of the institutions that carry out the State policy in the field of the food chain – in accordance with the specific nature of the activities carried out.
Art. 14. (1) within one month of the program design under art. 13 institutions and bodies under art. 3, al. 1, item 4 send them at CORHV.
(2) the Centre for risk assessment on food chain within one month of receipt of the programmes referred to in paragraph 1. 1 you may make suggestions and recommendations for amending or supplementing the training programmes.
Art. 15. (1) the trainers under art. 16 item 1 send information to CORHV for any training conducted within one month after the meeting.
(2) within three months after the relevant training institutions and bodies under art. 3, al. 1, item 4 Verify the results thereof in accordance with the instructions issued by the relevant authority, and send information at CORHV.
Art. 16. the Centre for risk assessment on food chain maintains a database for:
1. universities, institutes and other organizations and persons entitled to train employees and persons under art. 13;
2. trainings;
3. the training sessions organized by the structures of the European Union, international organisations and third countries;
4. training for the calendar year concerned.
Chapter three MANAGEMENT AUTHORITIES art. 17. the management authorities of the CORHV are:
1. the Director;
2. the Board of Directors.
Art. 18. (1) the Director of the CORHV is appointed by the Prime Minister upon a proposal of the Minister of agriculture and food.
(2) to the Director of CORHV habilitirano is appointed person with experience of not less than 10 years in the field of the safety of the food chain.
(3) the Director shall:
1. represent CORHV;
2. the authorising officer is the budget and the accounts for funds from the European Union;
3. exercise the functions of the authority of appointment in respect of civil servants and of the employer in respect of employees working under an employment relationship in the administration of the CORHV;
4. perform other functions related to the activities of CORHV.
(4) in the exercise of its powers, the Director of the CORHV is assisted by a Deputy Director.
(5) the Deputy Director of the CORHV shall be appointed by the Minister of agriculture and food on a proposal from the Director of CORHV. The Deputy Director shall be appointed a person with experience of not less than 8 years in the field of the safety of the food chain.
Art. 19. (1) the activities of the CORHV is carried out by the Administration, which employs persons officially and with an employment relationship. For employees with an employment relationship shall be applied art. 107 (a) of the labour code.
(2) For the administration of CORHV shall apply the law of the Administration, unless otherwise provided in this Act.
(3) the structure, composition and size of the CORHV, as well as the functions of its bodies shall be determined by the rules of procedure adopted by the Council of Ministers.
Art. 20. (1) the Management Board of CORHV consists of 5 members – Director of CORHV, who is a member in law, and two Deputy Ministers of agriculture and food and health care, appointed by the Minister of agriculture and food, respectively, by the Minister of health.
(2) the members of the Management Board shall be appointed or dismissed by decision of the Council of Ministers. Upon dismissal of a member of the Governing Council the Minister under para. 1 proposes to appoint another representative until the expiry of the mandate.
(3) the Management Board shall be for a term of three years.
(4) the Management Board shall:
1. adopt the annual programme of work of the CORHV and report on its performance, as well as a report on the implementation of the budget;
2. take decisions to ensure the implementation of the activities of CORHV and the means for their implementation;
3. shall report annually on the implementation of the annual programme and budget of the CORHV of the Minister of agriculture and food.
(5) the Management Board shall meet not less than twice a year. Meetings are scheduled, if three of the members are present. Decisions shall be taken by a simple majority of the members present.
Art. 21. (1) the structure of the CORHV includes the contact center to the EFSA for communication and exchange of scientific information with the EFSA and with other international and national organizations on risk assessment in the food chain.
(2) Contact Centre at al. 1:
1. maintain a national database of experts in the different areas of the food chain;
2. carry out scientific cooperation through the coordination of the activities, development and implementation of joint projects, exchange of experience and best practices in the areas of competence of the EFSA under art. 36 of Regulation (EC) No 178/2002.
Art. 22. The State and local authorities, public organizations, natural and legal persons shall, upon request, to provide the necessary information and to assist the CORHV for the implementation of its activities.
Chapter four FINANCE and property art. 23. (1) the Centre for risk assessment on food chain is funded by:
1. budgetary subsidy;
2. international programmes, projects and contracts;
3. the revenue collected pursuant to art. 3, al. 4, art. 6, al. 4, art. 7, para. 2 and art. 10, para. (2);
4. donations and grants;
5. other income.
(2) the resources of the Al. 1 be expended for:
1. ensuring the activity of the CORHV;
2. development and implementation of research projects;
3. membership of CORHV in international organizations and participation in international activities;
4. participation and implementation of international projects, programs and contracts;
5. remuneration of external experts;
6. publishing activity;
7. Organization and participation in scientific events;
8. other expenses.
ADDITIONAL PROVISIONS
§ 1. For the purposes of this law, the definitions of art. 2 and 3 of Regulation (EC) No 178/2002, art. 2 of Council Regulation (EC) No 882/2004, art. 3 of Council Regulation (EC) No 1107/2009 art. 2 of Council Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers and under § 1 of the additional provisions of the law for the protection of plants.
§ 2. This law provides for implementing measures to:
1. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the General principles and requirements of food law, establishing the European food safety authority and laying down procedures in matters of food safety;
2. Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.
TRANSITIONAL AND FINAL PROVISIONS
§ 3. (1) the Centre for risk assessment on food chain is the successor of the assets, liabilities, rights and obligations, the archives of the Centre for the evaluation of risk established by the law on Bulgarian food safety agency.
(2) the labour and service of the staff of the Centre for the assessment of risk shall be governed under the conditions and by the procedure of art. 123 of the labour code and article. 87 (a) of the law on civil servants.
(3) pending the entry into force of the acts under § 5, paragraphs 1 and 2, the Centre for risk assessment on food chain carries out its activities in the previous row.
§ 4. Issued prior to the entry into force of this Act, documents from the Center for assessment of the risk reserve effect for the period for which they are issued.
§ 5. Within three months of the entry into force of this law the Council of Ministers: 1. adopt the rules of procedure of the Centre for the evaluation of risk in the food chain;
2. adapt the rules of procedure of the Bulgarian food safety agency in accordance with this law;
3. Approves the tariff referred to in art. 6, al. 4.
§ 6. Within three months of the entry into force of this Act, the Director of CORHV validate the price list under art. 3, al. 4.
§ 7. (1) pending the entry into force of the acts under § 5, items 1 and 2 in line current BABH continues to carry out its functions in the approval, renewal and review of the approval of active substances, safeners and synergists and evaluation of plant protection products in accordance with Regulation (EC) No 1107/2009.
(2) the labour and service of the staff of the operating functions BABH al. 1, are governed under the conditions and by the procedure of art. 123 of the labour code and article. 87 (a) of the Act on civil servants in accordance with the defined features and number of personnel in the rules of procedure of the Centre for the evaluation of risk in the food chain.
(3) proceedings Initiated by the approval, renewal and review of the approval of active substances, safeners and synergists shall be finished by the order, the hitherto BABH and in carrying out an assessment with an evaluation report on the authorisation, renewal, modification and withdrawal of authorisation for the placing on the market and use of plant protection products – from CORHV in accordance with this law.
(4) within three months of the entry into force of the acts under § 5, items 1 and 2 of the CORHV transmits BABH transmission-reception protocol instance documents for authorisation, renewal, modification and revocation of authorisations for the placing on the market and use of plant protection products on the market. The requested documents to 14 June 2011 for authorisation, renewal, modification and revocation of authorisations for the placing on the market and use of plant protection products shall be submitted to the CORHV within one year of the entry into force of the acts under § 5, items 1 and 2.
§ 8. The Centre for risk assessment on food chain evaluation of authorised plant protection products under § 15 para. 1 of the transitional and concluding provisions of the law for the protection of plants.
§ 9. In the Bulgarian Agency for food safety (edu., SG. 8 by 2011; amend., SG. 38 and 102 by 2012, from 2013, 15, 61, from 2014, 57/by 2015 and 14 from 2016) is hereby amended as follows:
1. In art. 3, al. 2, paragraph 3, the word "score" is replaced by "management".
2. In art. 4, al. 1 item 4 shall be repealed.
3. Articles 9 and 10 shall be repealed.
§ 10. The plant protection Act (promulgated, SG. 61 by 2014; amend., SG. 12 by 2015) the following amendments and additions:
1. In art. 3, al. 2 Add ", except in the cases under art. 2, al. 1, item 3 and 4 of the law on the Centre for risk assessment in the food chain ".
2. In art. 37, para. 1, after the word "review" is added "by the Centre for risk assessment in the food chain".
3. Article 38 shall be repealed.
4. In art. 41, para. 3 the words "the Ordinance under art. 38, para. 1 "be replaced with" Ordinance of the Minister of agriculture and food ".
5. In art. 42, para. 1 the words "art. 38, para. 1 "shall be replaced by" art. 41, para. 3. "
6. In art. 45, para. 2, after the word "protection" is added "except for valuations with reports on assessments for plant protection products".
7. In art. 46:
a) paragraph 2 is amended as follows:
"(2) the compliance of the product with the requirements of para. 1 be established by carrying out an assessment of the product. ';
(b)) in the Al. 3 the words "guest on al. 2, item 1 "shall be replaced by ' the assessment under paragraph 1. 2 ";
in) paragraph 4 shall be replaced by the following:
"(4) the assessment under paragraph 1. 2 shall be carried out by the CORHV upon receipt of a copy of the necessary documents. ";
(d)) paragraph 5 shall be repealed.
§ 11. The Food Act (promulgated, SG. 90 of 1999; amend., SG. 102 by 2003, no. 70 by 2004, no. 87, 99 and 105 by 2005, issue 30, 31, 34, 51, 55, 80 and 96 06, issue 31, 51 and 53 of 2007 No. 36 and 69 since 2008, 23/41, 74 , 82 and 93 from 2009, PCs. 23, 25, 59, 80 and 98 of 2010, PC. 8 by 2011, issue. 54 and 77 by 2012 PCs. from 2013, 68, St. 26 by 2014, PC. 14 and 56 by 2015 and St. 28 of 2016) in art. 17, al. 4 in the text before paragraph 1, after the word "risk" is added "the food chain".
§ 12. The law shall enter into force on the day of its publication in the Official Gazette.
The law was passed by the National Assembly 43-26 May 2016 and is stamped with the official seal of the National Assembly.
President of the National Assembly Tsetska Tsacheva:
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