Name of law
Law amending the Law on Protection from harmful chemicals




Name Bill
Bill amending the Law on Protection from harmful chemicals





Date of adoption
29/07/2010



Number / year Official Gazette
63/2010







DECREE № 245
Pursuant to Art. 98 pt. 4 of the Constitution of the Republic of Bulgaria
DECREE:
To be published in the "Official Gazette" Law amending the Law on Protection from harmful effects of chemicals adopted by the National Assembly of HLI July 29, 2010
Released in Sofia on August 2, 2010
President of the Republic, Georgi Parvanov
stamped with the state seal.
Minister of Justice Margarita Popova

Law amending the Law on Protection from harmful effects of chemicals (prom. SG. 10 of 2000 .; Amend. No. . 91 2002 pcs. 86 and 114 in 2003, pcs. 100 and 101 of 2005, pcs. 30, 34, 80 and 95 of 2006, pcs. 53, 82 and 110 of 2008 on)
§ 1. In the name of the law, the word "preparations" is replaced by "mixture".
§ 2. In art. 1 is amended as follows:
1. In item. 1 and 2 "chemicals" are replaced by "chemical substances on their own, in mixtures or in articles."
2. Point 3 is amended as follows:
"3. implementing measures to:
a) Regulation (EC) № 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Agency chemicals, amending Directive 1999/45 / EC and repealing Regulation (EEC) № 793/93 and Council Regulation (EC) № 1488/94 of the Commission and Council Directive 76/769 / EEC and Directives 91/155 / EEC, 93/67 / EEC, 93/105 / EC and 2000/21 / EC, hereinafter "Regulation (EC) № 1907/2006 (REACH)";
B) Regulation (EC) № 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labeling and packaging of substances and mixtures, amending and repealing Directives 67/548 / EEC and 1999 / 45 / EC amending Council Regulation (EC) № 1907/2006 (OB, L 353/1 of 31 December 2008), hereinafter "Regulation (EC) № 1272/2008 (CLP)";
C) Regulation (EC) № 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents, hereinafter "Regulation (EC) № 648/2004";
D) Regulation (EC) № 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicals (OB, L 204/1 of 31 July 2008), hereinafter referred to 'Regulation (EC) № 689/2008 ";
E) Regulation (EC) № 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117 / EEC, hereinafter "Regulation (EC) № 850/2004 ";
E) Regulation (EC) № 1451/2007 of 4 December 2007 on the second phase of the 10-year work program referred to in Article 16 paragraph 2 of Directive 98/8 / EC of the European Parliament and of the Council concerning the placing of biocidal products (OB, L 325/3 of 11 December 2007), hereinafter "Regulation (EC) № 1451/2007". "
§ 3. Article 3 is amended as follows:
"Art. 3. (1) Chapters Two and Four shall not apply to:
1. The following mixtures in the finished state, intended for the end user:
a) medicinal products for human and veterinary medicine products;
B) cosmetic products;
C) foodstuffs for humans and animals;
D) medical devices;
2. waste under the Law on Waste Management; 3
. radioactive substances and nuclear materials within the meaning of the Safe Use of Nuclear Energy;
4. in transit through the territory of the Republic of Bulgaria chemical substances and mixtures which are subject to customs supervision and undergo treatment or processing;
5. transport of dangerous substances and dangerous mixtures by rail, road, inland waterway, sea or air transport.
(2) The requirements of Chapter II classification, packaging and labeling also apply to plant protection products in compliance with the Ordinance to resolve plant protection products (SG. 81 of 2006) and the Ordinance on procedures for labeling of plant protection products (prom. SG. 54 of 2003 .; amend. and suppl., SG. 17 of 2006).
(3) The measures for implementing Regulation (EC) № 648/2004, introduced in Chapters third, seventh and eighth shall be implemented in accordance with Art. 1 and Art. 3 (1) of the Regulation.
(4) The measures for implementing Regulation (EC) № 1907/2006 (REACH), introduced in Chapter Five, Seven and Eight are applied in accordance with Art. 2, Art. 15, art. 16, art. 56 (3), (4) and (5), Art. 67 and Art. 68 (1) of the Regulation.

(5) The measures for implementing Regulation (EC) № 1272/2008 (CLP), introduced in Chapter Five, Seven and Eight are applied in accordance with Art. 2 of the Regulation.
(6) The measures for implementing Regulation (EC) № 689/2008, introduced in Chapters Six, Seven and Eight are applied in accordance with Art. 2 of the Regulation.
(7) The measures for implementing Regulation (EC) № 850/2004, introduced in Chapters Six, Seven and Eight are applied in accordance with Art. 1 and Art. 4 of the Regulation. "
§ 4. In art. 4 made the following amendments:
1. The previous text becomes para. 1.
2. A par. 2:
"(2) Any advertisement for a mixture classified as dangerous or containing a substance classified as hazardous, which allows the general public to conclude a contract for purchase without first having seen the label indicating the category or categories of danger indicated on the label. "
§ 5. Article 4a is amended as follows:
" Art. 4a. Persons under Art. 1 pt. 1 are required to:
1. manufactured, marketed, used, stored and exported chemicals on their own, in mixtures or in articles and / or mixtures in a manner that prevents or limits their harmful effects on human health and the environment in accordance with the requirements of this law, regulations for its implementation and regulations specified in Art. 1, p. 3;
2. provide free access to the bodies of art. 27 para. 1 and 2 to enterprises and sites where production takes place, marketing, use, storage and export of chemical substances on their own, in mixtures or in articles and / or mixtures; 3
. maintain and make available to the bodies of art. 27 para. 1 and 2 information and documents:
a) the production, marketing, use, storage and export of chemical substances on their own, in mixtures or in articles and / or mixtures, including quantities and composition;
B) the identity of their immediate suppliers and customers of chemical substances and mixtures. "
§ 6. Article 4b shall be amended as follows:
" Art. 4b. (1) The procedure and manner of storage of hazardous chemical substances and mixtures is determined by an ordinance of the Council of Ministers.
(2) The procedure for limiting the manufacture, use or marketing of certain dangerous substances, mixtures and articles Annex XVII of Regulation (EC) № 1907/2006 (REACH) shall be determined by an ordinance of the Council of Ministers . "
§ 7. Members 4c and 4d canceled.
§ 8. In art. 5 is amended as follows:
1. In para. 4 words "properties under par. 1 "is replaced by" toxicological and ecotoxicological properties. "
2. Paragraph 7 is repealed.
§ 9. Article 5b is repealed.
§ 10. Article 6 is amended as follows:
"Art. 6. (1) It is prohibited the marketing of chemical substances and mixtures classified as hazardous that are not packaged and labeled in accordance with the requirements of the ordinance under Art. 5 para. 2.
(2) chemical mixtures not classified as dangerous, but can represent a specific danger, packed and labeled in accordance with the requirements of the ordinance under Art. 5 para. 2.
(3) Additional requirements for packaging and labeling of certain chemical substances and mixtures are determined in accordance with Art. 5 para. 2. "
§ 11. Article 7 is repealed.
§ 12. A new Chapter Three:
"Chapter Three
MEASURES FOR THE IMPLEMENTATION OF REGULATION (EC) № 648/2004
Art. 8. Minister of Environment and Water is the competent authority under Art. 8 (1) of Regulation (EC) № 648/2004.
Art. 9. (1) Exemption from the requirements of Annex III of Regulation (EC) № 648/2004 of the ultimate aerobic biodegradability of surfactants and detergents containing surfactants is carried out under Art. 5 and 6 of Regulation (EC) № 648/2004.
(2) Manufacturers of detergents for industrial and institutional detergent containing surfactants and / or surfactants for detergents for industrial and institutional purposes, which meet the criteria for primary biodegradability in Annex II of Regulation (EC) № 648/2004, but do not meet the criteria for ultimate aerobic biodegradability in Annex III, are eligible for release under par. 1.
(3) The persons under par. 2 submitted to the Minister of Environment and Water and the European Commission an application for release, accompanied with technical documentation in accordance with Art. 5 of Regulation (EC) № 648/2004.
(4) For errors and omissions in the documents under par. 3 Minister of Environment and Water or an authorized officer shall notify the applicant within 30 days from the date of filing the documents and set a deadline for their removal.
(5) The technical documentation is evaluated for completeness and compliance with the conditions for a derogation under Art. 6 (1) of Regulation № 648/2004.

(6) The Minister of Environment and Water or an official authorized by him shall send the conclusions of the evaluation to the European Commission according to the deadlines specified in Art. 5 (3) of Regulation (EC) № 648/2004.
Art. 10. (1) The Executive Agency "Bulgarian Accreditation Service" available on request to the Minister of Environment and Waters list of laboratories accredited to perform testing of surfactants in accordance with Art. 7 of Regulation (EC) № 648/2004.
(2) The Minister of Environment and Water or an authorized officer shall forward the information under par. 1 of the European Commission and the Member States in accordance with Art. 8 (2) of Regulation (EC) № 648/2004.
Art. 11. Not allowed graphical display of fruit on the packaging of liquid detergents that are marketed for general use, which could be misleading for the end user on the intended use of liquid detergents. "
§ 13. In art. 14b para. 1 the words "Chapter II" are replaced by "Regulation (EC) № 1272/2008 (CLP)".
§ 14. In Chapter Four, Section I create art. 14f:
"Art. 14f. (1) Persons who place on the market of biocidal products submitted annually by 31 March at the Clinic of Toxicology Hospital for Active Treatment and Emergency Medicine "N. Pirogov "information on paper and electronically on the chemical composition, physico-chemical and toxicological properties of marketed biocides in the previous year.
(2) Department of Toxicology Hospital for Active Treatment and Emergency Medicine "N. Pirogov "is the competent authority under Art. 23 of Directive 98/8 / EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products.
(3) The information under par. 1 is used only for medical purposes in the planning of preventive and curative emergency measures to protect the life and health of people.
(4) The body of para. 2 protect the confidentiality of information received.
(5) The medical institutions send to the authority under par. 2 and to regional health centers with information on cases of poisoning or suspected poisoning with biocidal products.
(6) The body of para. 2 sent annually by April 31 the Ministry of Health summary report for the previous year for cases of poisoning or suspected poisoning biocides and a list of persons submitted information under par. 1.
(7) The terms and conditions for providing information under par. 1, 5 and 6 shall be determined by the Minister of Health. "
§ 15. In art. 18d para. 3 is amended as follows:
"(3) The data for existing active substances provided for the purposes of this Act shall be protected for a period up to May 14, 2014, in cases where a decision of the Commission to include the active substance in the lists under Art. 14, para. 4 pt. 1 - the date specified by the Commission, to implement the provisions of Art. 19v if this date is later than May 14, 2014 "
§ 16. In art. 18e, para. 3 p. 1 is amended as follows:
"1. data submitted for the purposes of this Act shall be protected for a period up to May 14, 2014, and where there is a decision of the Commission to include the active substance in the lists under Art. 14, para. 4 pt. 1 - the date specified by the Commission, to implement the provisions of Art. 19v if this date is later than May 14, 2014 .; ".
§ 17. In art. 19e Para. 4 words "17. Pesticides "are replaced by" 17. Piscicides. "
§ 18. In art. 19e, para. 2 pt. 1 the words "current certificate of registration in the commercial register" is replaced by "unified identification code under Art. 23 of the Commercial Register Act. "
§ 19. The title of Chapter V is amended as follows: "Measures for the implementation of Regulation (EC) №1907 / 2006 (REACH) and Regulation (EC) №1272 / 2008 (CLP)".
§ 20. In art. 20 words "Regulation № 1907/2006" is replaced by "Regulation (EC) № 1907/2006 (REACH) and Art. 43 of Regulation (EC) № 1272/2008 (CLP) ".
§ 21. In art. 21 be made the following amendments:
1. Paragraph 2 is amended as follows:
"(2) Advisory Board includes representatives of the Ministry of Environment and Water, Ministry of Health and the National Center for Public Health Protection."
2. Paragraph 4 is amended as follows:
"(4) The Minister of Environment and Water, if necessary, can draw on the work of the expert council and specialists in chemistry, physical chemistry, ecotoxicology, toxicology, biology, occupational medicine and other professionals in order determined by the regulations under par. 3. "
third. In para. 6 words "draft decision" is replaced by "detailed report with conclusions of the assessment, accompanied by a draft decision in accordance with Art. 48 of Regulation (EC) № 1907/2006 (REACH) ".
4. Paragraph 7 is amended as follows:
"(7) Based on the results of the assessment expert council may submit to the Minister of Environment and Waters for reasoned proposal:

1. harmonized classification and labeling of a substance in accordance with Art. 37 (1) of Regulation (EC) № 1272/2008 (CLP);
2. identify the substance in accordance with Art. 59 (3) of Regulation (EC) № 1907/2006 (REACH); 3
. contain the substance in accordance with Art. 69 (4) of Regulation (EC) № 1907/2006 (REACH). "
5. Created al. 8-10:
"(8) The Minister of Environment and Water or an authorized officer shall notify the European Chemicals Agency for the results of the evaluation in accordance with Art. 48 of Regulation (EC) № 1907/2006 (REACH).
(9) Expert Council consider proposals from manufacturers, importers or downstream users under Article 37 (6) of Regulation (EC) № 1272/2008 (CLP) to change the harmonized classification and labeling of dangerous substances marketed in Bulgaria.
(10) The work of the expert council for assessment of priority substances shall be provided with funds by the European Chemicals Agency in accordance with Art. 14 (1) of Regulation (EC) № 340/2008 of the Commission for fees and charges payable to the European Chemicals Agency in accordance with Regulation (EC) № 1907/2006 (REACH) (OJ, L 107/6 of 17 April 2008). "
§ 22. In art. 21a be made the following amendments:
1. Paragraphs 1 and 2 are amended as follows:
"(1) The Minister of Environment and Water or an authorized officer shall prepare and send reports to the European Commission under Art. 117 (1) of Regulation (EC) № 1907/2006 (REACH) and reports under Art. 46 (2) of Regulation (EC) № 1272/2008 (CLP) to the European Chemicals Agency established procedure for cooperation with the EU institutions.
(2) The Minister of Health, Executive Director of the Executive Agency "General Labour Inspectorate", the Director of "Customs" Agency, the Executive Director of the National Revenue Agency and the Chairman of the National Statistical Institute upon request by the Minister of Environment and water or an authorized officer information pursuant to Art. 127 of Regulation (EO) № 1907/2006 (REACH) for the purpose of reporting under Art. 117 (1) of the Regulation. "
2. A par. 3:
"(3) The Minister of Health shall provide upon request by the Minister of Environment and Waters or by an authorized official summary results of monitoring the implementation of Regulation (EC) № 1272/2008 (CLP) for reporting purposes under Art. 46 (2) of the Regulation. "
§ 23. A Art. 21b:
"Art. 21b. (1) The Ministry of Environment and Water to establish and administer a national information bureau in accordance with Art. 124 of Regulation (EO) № 1907/2006 (REACH) and Art. 44 of Regulation (EC) № 1272/2008 (CLP) in order to provide advice to manufacturers, importers, downstream users and distributors of chemical substances on their own, in mixtures and in articles and / or mixtures of their obligations execution of both regulations.
(2) In performing their obligations under par. 1 national helpdesk is supported by the Ministry of Health and the National Center for Public Health Protection. "
§ 24. A Art. 21c:
"Art. 21c. (1) The importers and downstream users who marketed mixtures classified as hazardous on the basis of their health effects or physical effects under Regulation (EC) № 1272/2008 (CLP), available at the Clinic of Toxicology Hospital active treatment and emergency Medicine "N. Pirogov "information about the chemical composition of these mixtures, including chemical identity of these substances in the mixtures are allowed to use an alternative chemical name under Art. 7d par. 3 of this Act and art. 24 of Regulation (EC) № 1272/2008 (CLP).
(2) Department of Toxicology Hospital for Active Treatment and Emergency Medicine "N. Pirogov "is the competent authority under Art. 45 of Regulation (EC) №1272 / 2008 (CLP).
(3) The information under par. 1 is presented annually by March 31 and covers placed on the market during the previous calendar year mixes all importers or downstream users.
(4) The form for submission of information under par. 1 shall be established in accordance with Art. 45 (4) of Regulation (EC) № 1272/2008 (CLP).
(5) The medical institutions send to the authority under par. 2 and to regional health centers with information on cases of poisoning or suspected poisoning mixtures classified as hazardous on the basis of their health effects or physical effects.
(6) The body of para. 2 sent annually by 30 April at the Ministry of Health summary report for the previous year for cases of poisoning or suspected poisoning with mixtures classified as hazardous based on their effects on health or physical effects, and a list of persons submitted information under par. 1. "
§ 25. A Art. 21d:

"Art. 21d. Compliance with the principles of Good Laboratory Practice by the laboratories in the performance of ecotoxicological and toxicological tests and analyzes of chemical substances for the purposes of Regulation (EO) № 1907/2006 (REACH) and Regulation (EC) № 1272/2008 (CLP) is certified by Executive Agency "Bulgarian accreditation service" according to the ordinance under Art. 5 para. 6. "
§ 26. The title of Chapter Six is ​​amended as follows:" Measures for implementing Regulation (EC) № 689/2008 and (EC) № 850/2004 ".
§ 27. Article 22 is amended as follows:
"Art. 22. Minister of Environment and Water is the competent authority under Art. 4 of Regulation (EC) № 689/2008 and art. 15 of Regulation (EC) № 850/2004. "
§ 28. In art. 22a be made the following amendments:
1. Paragraph 1 shall be amended as follows:
"(1) Before the first annual export of chemicals in accordance with Art. 7 (1) or article under Art. 14 (1) of Regulation (EC) № 689/2008 exporter submit to the Ministry of Environment and Water export notification in paper and electronic form under Art. 7 of this Regulation. "
2. A par. 4:
"(4) Exports of chemicals from Parts 2 and 3 of Annex I of Regulation (EC) № 689/2008 is subject to a written consent of the competent authorities of the destination countries."
§ 29 . In art. 22b are made the following amendments:
1. In para. 1 p. 1 and 2 are amended as follows:
"1. Chemicals in art. 7 (1) or articles of art. 14 (1) of Regulation (EC) № 689/2008 - before the expiration of terms of art. 7 (2) of the Regulation;
2. Chemicals from Parts 2 and 3 of Annex I of Regulation (EC) № 689/2008 - in 5 days after receipt of written consent from the competent authority of the country of destination. "
2. Paragraph 2 is amended as follows:
"(2) The opinion under par. 1 pt. 1 is valid until the end of the calendar year except in cases of art. 7 (4) of Regulation (EC) № 689/2008. "
Third. Created al. 3 and 4:
"(3) In the opinion paragraph. 1 pt. 2 sets out requirements for the export of the country of destination and the validity of the granted consent.
(4) The opinion under par. 1 is available to the customs authorities upon request. "
§ 30. Article 22c is amended as follows:
" Art. 22c. (1) Prior to export of chemicals in Annex I or Annex V of Regulation (EC) № 689/2008 for laboratory or research purposes in quantities up to 10 kg exporter submit to the Ministry of Environment and Water export notification in paper and electronically to generate a reference identification number in the database export and import of dangerous chemicals by the European Commission (EDEXIM).
(2) export notification under par. 1 must be indicated intended use and quantity of exported substance.
(3) Prior to export of chemicals in Part 3 of Annex I of Regulation (EC) № 689/2008 to countries of destination, provided consent to import these chemicals under Art. 13 (6), letter b) of the Regulation, the exporter shall submit to the Ministry of Environment and Water export notification in paper and electronic form to generate a reference identification number in EDEXIM.
(4) The reference identification number for exports under par. 1 and 3 are available to the exporter within 5 working days from the date of notification to be used in forming the Single Administrative Document for export.
(5) processing notifications under par. 1 and 3 no charge under Art. 72 of the Law on Environmental Protection. "
§ 31. In art. 22d is amended as follows:
1. In para. 1 and 2 "Regulation 304/2003" are replaced by "Regulation (EC) № 689/2008".
2. In para. 3:
a) point 1 is amended as follows:
"1. exported and imported into the customs territory of the Republic of Bulgaria chemicals and mixtures of Annex I of Regulation (EC) № 689/2008 of the reporting period; "
b) in item. 3 the words" Regulation 304/2003 "are replaced by "Regulation (EC) № 689/2008".
§ 32. created new art. 22g - 22g:
"Art. 22e. Each year up to March 31 exporters and importers of chemical substances on their own, in mixtures and in articles by Annex I of Regulation (EC) № 689/2008 submitted to the Ministry of Environment and Water information on exported and imported in the previous year chemicals according to Art. 9 of Regulation (EC) № 689/2008.
Art. 22f. (1) The Minister of Environment and Water draw up and update the National Action Plan for Management of Persistent Organic Pollutants and send it to the European Commission and the Member States in accordance with Art. 8 of Regulation (EC) № 850/2004.
(2) The plan under par. 1 adopted by the Council of Ministers.
Art. 22g. (1) The Minister of Environment and Water or an authorized officer shall prepare and submit reports on the implementation of Regulation (EC) № 850/2004 to the European Commission.

(2) The Minister of Agriculture and Food, the Minister of Health, Director of "Customs" Agency, the Executive Director of the National Revenue Agency and the Chairman of the National Statistical Institute provided upon request by the Minister of Environment and Water or authorized by him official information in a prescribed format for reporting under Art. 12 of Regulation (EC) № 850/2004. "
§ 33. Articles 24 and 24a shall be repealed.
§ 34. Article 25 is amended as follows:
"Art. 25. control shall be subject to fulfillment of the requirements:
1. classification, packaging and labeling of chemical substances and mixtures in accordance with Chapter II;
2. classification, labeling and packaging of chemical substances, mixtures and specific products under Regulation (EC) № 1272/2008 (CLP); 3
. notification to the European Chemicals Agency for the classification and labeling of marketed hazardous chemicals on their own and in mixtures under Regulation (EC) № 1272/2008 (CLP);
4. registration of chemical substances on their own, in mixtures and in articles under Regulation (EC) № 1907/2006 (REACH);
5. exchange of information on substances and avoidance of unnecessary testing under Regulation (EC) № 1907/2006 (REACH);
6. downstream users under Regulation (EC) № 1907/2006 (REACH);
7. information down the supply chain for chemical substances on their own, in mixtures and in articles under Regulation (EC) № 1907/2006 (REACH);
8. resolution of certain hazardous chemicals under Regulation (EC) № 1907/2006 (REACH);
9. limiting production, marketing and use of certain dangerous substances, mixtures and articles under Regulation (EC) № 1907/2006 (REACH) and the ordinance of art. 4b, para. 2 to protect the environment;
10. restricting the marketing and use of certain dangerous substances, mixtures and articles under Regulation (EC) № 1907/2006 (REACH) and the ordinance of art. 4b, para. 2 in order to protect human health;
11. ensuring access of workers to hazardous chemicals to information on chemical substances and mixtures according to Art. 35 of Regulation (EC) № 1907/2006 (REACH) and implementing control measures Occupational exposure specified in the safety data sheet;
12. Export and import of dangerous chemicals on their own, in mixtures or in articles under Regulation (EC) № 689/2008;
13. providing information on export and import of dangerous chemicals on their own, in mixtures or in articles under Regulation (EC) № 689/2008;
14. ban and limit production, marketing and use of persistent organic pollutants within the scope of Regulation (EC) № 850/2004;
15. providing information on persistent organic pollutants within the scope of Regulation (EC) № 850/2004;
16. storage of hazardous chemical substances and mixtures according to the ordinance under Art. 4b, para. 1 and the conditions referred to in the safety data sheet of the manufacturer, importer or downstream user;
17. biodegradability of surfactants and detergents containing surfactants under Regulation (EC) № 648/2004;
18. labeling and packaging of detergents and surfactants for detergents in accordance with Regulation (EC) № 648/2004;
19. information on ingredients of detergents under Regulation (EC) № 648/2004;
20. placing on the market of biocidal products, including basic substances;
21. conducting research and development activities, including carrying out experiments in which the environment is released or can be released biocide or active substance;
22. providing information on marketed biocides and mixtures classified as hazardous based on their effects on health or physical effects, in order to plan preventive measures and treatment and protection of life and health. "
§ 35. Article 26 is amended as follows:
"Art. 26. (1) The control of this law is preventive, current and follow.
(2) Preventive control is performed through the procedures for authorization for placing on the market of biocidal products under Chapter Four.
(3) is assessed by performing:
1. planned inspections based on an annual plan for control activities;
2. investigates complaints and reports of physical or legal entities; 3
. checks in case of doubt;
4. checks on request from the European Chemicals Agency or a competent authority of another Member - State of the European Union or another country - party to the Agreement on the European Economic Area.
(4) Subsequent control is done by tracking the implementation of the prescriptions of controlled persons during the inspection, and imposed under this Act coercive administrative measures.

(5) The control is done through checks on documents and on-site sampling, laboratory analysis, observations and measurements.
(6) The control is done through independent or joint inspections of the bodies of art. 27.
(7) In the exercise of control bodies under Art. 27 para. 1 and 2 up finding records.
(8) protocols under par. 7 reflected the established facts and circumstances and give obligatory prescriptions for removal of discrepancies and irregularities indicating the time and responsible for their implementation.
(9) The Minister of Environment and Water, Minister of Health and Minister of Labour and Social Policy within their competence issue joint guidelines for the conduct of control over the implementation of this law, regulations for its implementation and Regulations referred to in Art. 1, p. 3. "
§ 36. Article 27 is amended as follows:
" Art. 27. (1) The Minister of Environment and Water or officials authorized by him shall exercise control in the cases of art. 25 pt. 3-9 and 13-17 in order to protect the environment.
(2) The Minister of Health or authorized by him shall exercise control in the cases of art. 25 pt. 1, 2, 7, 10 and 18-22 to protect the health of the population.
(3) The bodies of state control under the Plant Protection exercise control over the classification, packaging and labeling and safety data sheets placed on the market of plant protection products under the Law on Plant Protection.
(4) "Customs" Agency review in the cases of art. 25 pt. 12 under Regulation (EEC) № 2913/92 of the Council establishing a Community Customs Code and Regulation (EC) № 2454/93 laying down provisions for implementing Regulation (EEC) № 2913 / 92 of the Council establishing a Community Customs Code.
(5) The Executive Agency "General Labour Inspectorate" at the Ministry of Labour and Social Policy exercise control under the Labour Code in cases of art. 25 pt. 11 to ensure healthy and safe working conditions. "
§ 37. In art. 28 be made the following amendments:
1. In para. 1 pt. 1 and 2 the word "dangerous" is deleted.
2. Paragraph 2 is repealed. 3
. Paragraph 3 is amended as follows:
"(3) The body of art. 27 para. 4 entitled:
1. require documents and information and to take samples for laboratory analysis in relation to imports and exports of dangerous chemical substances on their own and in mixtures of Annexes I and V of Regulation (EC) № 689/2008;
2. suspected violations of the prohibitions and / or restrictions set out in Annex I or Annex V of Regulation (EC) № 689/2008 - to hold goods until a statement by the Minister of Environment and Waters or by an authorized official and in case of violations - to return substances, mixtures and / or products at the expense of the exporter / importer or authorized exports / imports person. "
4. Created al. 5-8:
"(5) If the result of the laboratory analysis / sample / samples of chemical / chemical substances on their own and in mixtures and / or a mixture bodies of art. 27 para. 1 and 2 establish a violation under this Act regulations for its implementation and regulations specified in Art. 1, p. 3, those responsible pay the cost of the analyzes.
(6) Where it is established that marketed chemical mixture and / or the biocidal product does not comply with the provisions of this Act, regulations for its implementation and / or regulations specified in Art. 1 pt. 3 and substance, mixture and / or the biocidal product presents a risk to health and safety of persons, the Minister of Health or an authorized officer may order the immediate and effective withdrawal of the substance or mixture and / or biocidal product from the market account of the person / persons responsible / accountable for marketing or seizure by the end user.
(7) The measures under par. 6 be taken in the event that all the measures taken were not sufficient to prevent or reduce the risk to human health.
(8) The customs authorities shall provide information at the request of the bodies of art. 27 para. 1 and 2 or appointed by those officials on the import of chemicals on their own and in mixtures that are subject to authorization and the import of chemical substances and mixtures which are subject to restrictions under Regulation (EC) № 1907/2006 (REACH), according to a prescribed format. "
§ 38. In art. 30 is amended as follows:
1. Paragraph 1 shall be amended as follows:

"(1) If there is new information that chemical and / or mixture which comply with the provisions of this Act, regulations for its implementation and the regulations referred to in Art. 1 pt. 3 and constitute an immediate danger to human health and / or environmental bodies under Art. 27 para. 1 and 2 may temporarily prohibit the placing on the market and use them. "
2. In para. 3, 'biocidal product or a registered biocide preparation "is replaced by" biocide or registered biocide. " 3
. In para. 5 in the first sentence the words "biocidal product" in the second sentence the words "biocidal product" are replaced by "biocide" and "biocide".
4. In para. 6 words "biocidal product" are replaced by "biocide".
§ 39. Article 33 is amended as follows:
"Art. 33. (1) The Minister of Environment and Water or authorized by officials in accordance with its powers stop production, marketing, use and / or export of chemical substances and / or mixtures.
(2) The Minister of Health or authorized by officials in accordance with its powers stop marketing and / or use of chemical substances, mixtures and / or biocides.
(3) The activities under par. 1 and 2 are stopped within the cause that led to the implementation of compulsory administrative measure.
(4) The application of coercive administrative measure by a reasoned order of the authorities under par. 1 and 2.
(5) In order under par. 4 determines the duration of compulsory administrative measure and the way of its implementation.
(6) The order under par. 4 shall be served on the person under the Civil Procedure Code. "
§ 40. Article 35 is amended as follows:
" Art. 35. (1) Punished person:
1. fails to fulfill its obligations under Art. 4a to the state control bodies specified in Art. 27 para. 1 and 2;
2. does not fulfill the mandatory instruction issued by an authority under Art. 27 para. 1 and 2; 3
. not fulfill its obligations under Art. 7f par. 1, Art. 14f and art. 15a;
4. advertises Chemical in violation of Art. 4 and art. 19sh;
5. does not store hazardous chemicals and mixtures in accordance with the requirements, conditions and information specified by the manufacturer, importer or downstream user in SDS;
6. violates the requirements for storage of hazardous chemical substances and mixtures according to the ordinance under Art. 4b, para. 1;
7. defaults classification, packaging and labeling of chemical substances and mixtures in accordance with Chapter II;
8. renege on classification, labeling and packaging of chemical substances, mixtures and certain products according to Art. 4 of Regulation (EC) № 1272/2008 (CLP);
9. defaults for identification and examination of available information on substances under Art. 5 to mixtures of art. 6 of Regulation (EC) № 1272/2008 (CLP);
10. not fulfill its obligations to limit and prevent tests on animals and humans in accordance with Art. 7 of Regulation (EC) № 1272/2008 (CLP);
11. defaults for assessment of hazard information and classification of substances and mixtures under Art. 9-15 of Regulation (EC) № 1272/2008 (CLP);
12. does not fulfill obligations to provide information on hazards of chemical substances and / or mixtures through the label under Art. 17-27 and art. 30-33 of Regulation (EC) № 1272/2008 (CLP);
13. defaults packaging of dangerous chemical substances and / or mixtures according to Art. 35 of Regulation (EC) № 1272/2008 (CLP);
14. not meet the requirements for harmonization of classification and labeling of a substance in accordance with Art. 37 (6) of Regulation (EC) № 1272/2008 (CLP);
15. not fulfill its obligations to notify the European Chemicals Agency pursuant to Art. 40 of Regulation (EC) № 1272/2008 (CLP);
16. not fulfill its obligations to provide information under Art. 45 of Regulation (EC) № 1272/2008 (CLP);
17. does not fulfill the requirements for promotion of chemical substances and mixtures according to Art. 48 of Regulation (EC) № 1272/2008 (CLP);
18. defaults for storing and providing information in accordance with Art. 49 of Regulation (EC) № 1272/2008 (CLP);
19. violates the requirements of Art. 3 and 5 (2) of Regulation (EC) № 850/2004;
20. biocide marketed without an authorization;
21. launches biocidal product without a certificate of registration;
22. launches major biocide use substances that are not included in the list of art. 14, para. 4 pt. 3;
23. conducted experiments in which the environment is released or can be released biocide or active substance without a permit issued;
24. launches active substance in violation of the requirements of Art. 18b;
25. launches biocidal product or biocidal product in violation of the conditions of the issued permit or certificate of registration;
26. fails to fulfill its obligations under Art. 17l, para. 4;

27. violate restrictions on biodegradability of surfactants and detergents containing surfactants according to Art. 4 of Regulation (EC) № 648/2004;
28. not provide information on the biodegradability of surfactants and detergents containing surfactants according to Art. 9 (1) of Regulation (EC) № 648/2004;
29. does not provide immediate and free information pursuant to Art. 9 (3) of Regulation (EC) № 648/2004;
30. not publish the list of ingredients of detergents in accordance with Annex VII, Part D of Regulation (EC) № 648/2004;
31. violates the requirements for labeling and packaging of detergents and surfactants for detergents in accordance with Art. 11 of Regulation (EC) № 648/2004 and art. 11 of the Act;
32. violates the requirements for production and marketing of chemical substances on their own, in mixtures and / or products and the marketing of mixtures pursuant to Art. 5 of Regulation (EC) № 1907/2006 (REACH);
33. defaults:
a) for the registration of chemical substances on their own, in mixtures or in articles under Art. 6 (1), (2) and (3) Art. 7 (1), (2) and (5), Art. 8 (2), Art. 9 (6) and Art. 14 (1) (6) and (7) of Regulation (EC) № 1907/2006 (REACH);
B) the preparation and submission of safety data sheets and information in the supply chain according to Art. 31 (1), (2), (3), (7) and (9), Art. 32 (1) and (3) Art. 33 (1), Art. 34, art. 37 (4), (5), (6) and (7), art. 38 (1), (3) and (4) and Art. 39 (1) and (2) of Regulation (EC) № 1907/2006 (REACH);
C) in connection with the evaluation of dossiers and substances pursuant to Art. 40 (4) and Art. 50 (4) of Regulation (EC) № 1907/2006 (REACH);
D) the authorization of chemical substances on their own, in preparations and / or products in accordance with Art. 56 (1) and (2), Art. 60 (10) and Art. 65 of Regulation (EC) № 1907/2006 (REACH);
E) limiting production, use or marketing of chemical substances, mixtures and / or products in accordance with Art. 67 (1) of Regulation (EC) № 1907/2006 (REACH);
34. defaults:
a) for the registration of chemical substances on their own, in preparations or in articles under Art. 7 (3), Art. 8 (3), Art. 9 (2), Art. 11 (1) and (3) Art. 12 (2), Art. 13 (1), (2) and (3), art. 17 (1), Art. 18 (1), Art. 19 (1), Art. 22 (1), (2) and (4) Art. 24 (2) and Art. 28 (1) and (6) of Regulation (EC) № 1907/2006 (REACH);
B) to exchange data and testing on vertebrate animals pursuant to Art. 25 (1) and (2), Art. 26 (1) and (3) Art. 29 (3) and Art. 30 (1), (2) and (6) of Regulation (EC) № 1907/2006 (REACH);
C) preparation and submission of safety data sheets and information in the supply chain according to Art. 31 (5), (6) and (8) art. 32 (2), Art. 33 (2), Art. 36 (1) and (2) and Art. 37 (2) and (3) of Regulation (EC) № 1907/2006 (REACH);
D) in connection with the evaluation of dossiers, substances and intermediates under Art. 40 (4), Art. 41 (4), Art. 46 (2), Art. 49 and Art. 50 (2) and (3) of Regulation (EC) № 1907/2006 (REACH);
E) the authorization of chemical substances on their own, in preparations or in articles under Art. 60 (8), Art. 61 (1) and Art. 66 (1) of Regulation (EC) № 1907/2006 (REACH);
E) to provide additional information to the European Chemicals Agency pursuant to Art. 20 (2) and Art. 21 (2) of Regulation (EC) № 1907/2006 (REACH);
35. not fulfill its obligations to notify export of dangerous chemical substances on their own, in mixtures and / or products in accordance with Art. 7 and art. 14 (1) of Regulation (EC) № 689/2008;
36. fails to comply with restrictions on the export of dangerous chemical substances on their own and / or mixtures according to Art. 13 of Regulation (EC) № 689/2008;
37. violate export bans of art. 14 (2) of Regulation (EC) № 689/2008;
38. not fulfill its obligations to provide information under Art. 9, 15 and 16 of Regulation (EC) № 689/2008.
(2) For violations of art. 35 of Regulation (EC) № 1907/2006 (REACH) penalties are imposed under the Labour Code.
(3) For violations under par. 1 individuals shall be punished by a fine and legal entities - with a property sanction in the amount as follows:
1. by m. 7, 8, 19, 20, 22, 23, 24, 32 and 33 - 10 000 100 000 lev .;
2. under p. 3, 10, 11, 12, 13, 15, 16, 18, 21, 34, 36 and 37 - from 5000 to 50 000. lev .; 3
. under item. 1, 2, 4, 5, 6, 9, 14, 17, 25, 26, 27, 28, 29, 30, 31, 35 and 38 - from 1000 to 40000 lev.
(4) for repeated violation the fine, respectively proprietary sanction under par. 3 shall be doubled. "
§ 41. § 1 of the additional provision is amended as follows:
1. In item. 2 the word "preparations" is replaced by "mixture".
2. Points 4 and 5 are canceled. 3
. In pt. 6, 7, 8, 13 and 16 everywhere the words "preparation" and "preparations" is replaced by "mixture" and "mixtures".
4. In item. 17 the word "dangerous" is deleted and the word "preparations" is replaced by "mixture".
5. In item. 19 words "biocide preparation" and "biocidal product" are replaced by "biocide mixture" and "The biocidal mixture".

6. In t. 25, 27, 28, 29 and 30 the words "biocidal product", "biocidal product", "biocidal product", "biocidal product" and "preparations" are replaced by "biocide", "biocide", "biocide "" biocidal products "and" biocides ".
7. In item. 36 and 40 the word "preparations" is replaced by "mixture".
§ 42. In § 5 of the transitional and final provisions, the words "the Minister of Agriculture and Food" and the comma after they are deleted.
§ 43. Paragraph 27 of the transitional and final provisions of the Law amending the Law on Protection from harmful effects of chemicals (prom. SG. 95 of 2006 .; amend., SG. 82 in 2007) is amended as follows:
"§ 27. (1) The provisions of Title XVII of Chapter Four shall apply until 14 May 2014
(2) where a Commission decision to include active substance in the lists under Art. 14, para. 4 pt. 1 or 2 is set at a later date of May 14, 2014 to implement the provisions of Art. 19v, Section XVII of Chapter Four shall apply to biocidal products containing an active substance by that date. "
§ 44. In art. 15c, para. 2 pt. 1, Art. 17, para. 3 pt. 1, Art. 17e, para. 3 pt. 1, Art. 17i para. 2 pt. 1, Art. 17k para. 4 pt. 1, Art. 17n, para. 2 pt. 1 and par. 3 pt. 1 the words "current certificate of registration in the commercial register" is replaced by "unified identification code under Art. 23 of the Commercial Register Act. " Additional provisions

§ 45. In the names of the heads of the second and seventh chapters and across the first, second, sixth, seventh and eighth words "preparation", "preparation", "preparation" and "preparations" shall be replaced by "mixture", "mixture", "mixtures" and "mixtures".
§ 46. In Chapter Four everywhere the words "biocidal products", "biocidal product", "biocidal products", "biocidal product", "preparation", "preparation", "biocidal product", "preparation" and "preparations "are replaced by" biocides "," biocide "," biocides "," biocide "," biocides "," biocide "," biocide "," biocide "and" biocides ".
§ 47. Everywhere in the law the words "Regulation 2032/2003" is replaced by "Regulation (EC) № 1451/2007".
§ 48. This Act transposes the provisions of Directive 2009/107 / EC of the European Parliament and of the Council of 16 September 2009 amending Directive 98/8 / EC concerning the placing of biocidal products on the market as regards the extension of some limits (OJ, L 262/40 of 6 October 2009).
Transitional and Final Provisions
§ 49. The Council of Ministers adopt the ordinances under Art. 4b 9 months from the entry into force of this Act.
§ 50. The issued before the entry into force of this Act permits the marketing of biocidal products remain in force.
§ 51. Article 2, Art. 5 para. 1-3 and par. 5 and Art. 7b - 7f apply until May 31, 2015
§ 52. This Act shall enter into force on the day of its promulgation in the "Official Gazette" with the exception of § 14 and 24, which come into force from June 1, 2015 | || law was adopted by the 41 th National Assembly on July 29, 2010 and was affixed with the official seal of the National Assembly.
Chairman of the National Assembly Tsetska Tsacheva
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