Law Amending The Law On Protection Against Harmful Impact Of Chemical Substances And Mixtures

Original Language Title: Закон за изменение и допълнение на Закона за защита от вредното въздействие на химичните вещества и смеси

Read the untranslated law here: http://parliament.bg/bg/laws/ID/15529/

Name of law
Law amending the Law on Protection from harmful effects of chemical substances and mixtures




Name Bill
Bill amending the Law on Protection from harmful effects of chemical substances and mixtures





Date of adoption
16/12/2015



Number / year Official Gazette
102/2015








DECREE № 283
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 against Harmful Impact of Chemical Substances and Mixtures adopted by the National Assembly on HLIIІ December 16, 2015
Released in Sofia on December 23, 2015
President of the Republic: Rosen Plevneliev
stamped with the state seal.
Minister of Justice: Catherine Zaharieva

Law amending the Law on Protection against Harmful Impact of Chemical Substances and Mixtures (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, 2006, issue. 53 and 82 in 2007 No.. 110 of 2008, pcs. 63 and 98 in 2010, pcs. 84 of 2012 and SG. 61 of 2014)
§ 1. In art. 1 made the following amendments:
1. In item. 3:
a) letter "c" finally added "and Regulation (EU) № 259/2012 of the European Parliament and of the Council of 14 March 2012 amending Regulation (EC) № 648 / 2004 regarding the use of phosphates and other phosphorus compounds in consumer laundry detergents and consumer automatic dishwasher detergents (OJ, L 94/16 of 30 March 2012), hereinafter referred to as "Regulation (EU) № 259/2012 ';
B) letter "d" is amended as follows:
"d) Regulation (EU) № 649/2012 of the European Parliament and the Council of 4 July 2012 concerning the export and import of dangerous chemicals (OJ, L 201/60 of 27 July 2012), hereinafter "Regulation (EU) № 649/2012"; "
c) the letter" e "is amended as follows:
" e) delegated Regulation (EU) № 1062/2014 of the Commission of 4 August 2014 on the work program for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) № 528/2012 of the European Parliament and the Council (OB, L 294 / 1 of 10 October 2014), hereinafter referred to as "delegated Regulation (EU) № 1062/2014"; "
d) the letters" g "," h "and" and ":
" g) Regulation (EU) № 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the provision of market and use of biocidal products (OJ, L 167/1 of June 27, 2012), hereinafter " Regulation (EU) № 528/2012 "and Regulation (EU) № 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) № 528/2012 concerning the provision of market and use of biocidal products regarding certain conditions for access to the market (OB, L 103/22 of 5 April 2014);
H) Delegated Regulation (EU) № 492/2014 of the Commission of 7 March 2014 supplementing Regulation (EU) № 528/2012 of the European Parliament and of the Council as regards the rules for renewal of authorization for biocidal products subject to mutual recognition (OB, L 139/1 of 14 May 2014), hereinafter referred to as "delegated Regulation (EU) № 492/2014";
) Regulation (EU) № 98/2013 of the European Parliament and of the Council of 15 January 2013 on the marketing and use of explosives precursors (OJ, L 39/1 from February 9, 2013) , hereinafter "Regulation (EC) № 98/2013". "
2. A t. 5:
"5. supply requirements, introduction, possession and use of chemical substances and mixtures which are precursors to explosives and to report suspicious transactions involving these chemical substances and mixtures. "
§ 2. In art. 3 The following amendments and additions:
1. In para. 3, after the words "Regulation (EC) № 648/2004" insert "and Regulation (EU) № 259/2012", and the word "regulation" is replaced by "Regulation (EC) № 648/2004".
2. In para. 6 words "Regulation (EC) 689/2008" are replaced by "Regulation (EU) № 649/2012". 3
. Created al. 8 and 9:
"(8) The measures for implementing Regulation (EU) № 528/2012, introduced in Chapter Four, seventh and eighth shall be implemented in accordance with Art. 2 and 3 of the regulation.
(9) The measures for implementing Regulation (EC) № 98/2013, introduced in Chapter Six "and" shall be implemented in accordance with Art. 2 of the regulation. "
§ 3. In the title of Chapter III finally added" and Regulation (EU) № 259/2012 ".
§ 4. In art. 8 finally added "and Regulation (EU) № 259/2012".
§ 5. Chapter Four with art. 14 - 19y is repealed.
§ 6. A new chapter four new art. 14 - 19:
"Chapter Four

MEASURES FOR THE IMPLEMENTATION OF REGULATION (EU) № 528/2012 and provide market of biocidal products containing existing active substances, included in Annex II of Delegated Regulation (EU) № 1062/2014
Art. 14. The Minister of Health is the competent authority under Art. 81 (1) of Regulation (EU) № 528/2012.
Art. 14a. Biocidal products are available on the market and are used when they are authorized under this Act or in accordance with Regulation (EU) № 528/2012.
Art. 14b. Are marketed treated articles that meet the requirements of Regulation (EU) № 528/2012.
Art. 15. (1) The Minister of Health established by an order Expert Council on biocidal products.
(2) counsel under par. 1 representatives of the Ministry of Health, Ministry of Environment and Water, the National Center for Public Health and Analysis and the National Center of Infectious and Parasitic Diseases.
(3) The Minister of Health may draw, if necessary, in the Council under par. 1 and other specialists in toxicology, ecotoxicology, chemistry, biology, microbiology, virology, parasitology and veterinary medicine.
(4) The Council under par. 1 makes a proposal to the Minister of Health:
1. an opinion for holding or prohibition to conduct research and development of art. 56 (2) and (3) of Regulation (EU) № 528/2012;
2. a national authorization to provide the market of a biocidal product or a biocidal product or for refusing or terminating the proceeding under Art. 29 and 30 of Regulation (EU) № 528/2012; 3
. renewal of a national authorization to provide market biocide under Art. 31 of Regulation (EU) № 528/2012;
4. authorization to provide market biocidal product or a biocidal product in accordance with the simplified procedure, or refusing or terminating the proceeding under Art. 25 and 26 of Regulation (EU) № 528/2012;
5. authorization to provide market biocidal product or a biocidal products on mutual recognition in art. 33 and 34 of Regulation (EU) № 528/2012 or refusal, or to change the terms of a permit issued under Art. 35-37 of Regulation (EU) № 528/2012;
6. renewal of the authorization to provide the market of biocidal products on mutual recognition under Delegated Regulation (EU) № 492/2014;
7. authorization to provide market biocidal product or a biocidal products on mutual recognition in art. 39 of Regulation (EU) № 528/2012;
8. cancellation or modification of a national authorization to provide market biocide under Art. 48-50 of Regulation (EU) № 528/2012 and Chapters II and III of Regulation (EU) № 354/2013 of the Commission of 18 April 2013 on amendments to the biocidal products authorized under Regulation (EU) № 528/2012 of the European Parliament and the Council (OB, L 109/4 of April 19, 2013), hereinafter referred to as "implementing Regulation (EU) № 354/2013";
9. evaluating applications for authorization of the European Union, hereinafter referred to as "Union authorization" to provide market biocidal product or a biocidal product or for terminating the art. 43 (1), (3) and (4) and Art. 44 (1) and (2) of Regulation (EU) № 528/2012;
10. Evaluation of applications for renewal of authorization of the Union to provide market biocide under Art. 46 (1) and (2) of Regulation (EU) № 528/2012;
11. authorization for parallel trade of biocidal product or to refuse or to withdraw authorization for parallel trade of biocide under Art. 53 of Regulation (EU) № 528/2012;
12. Evaluation of applications for approval of an active substance for inclusion in the list of approved active substances in the European Union or terminating the art. 7 and 8 of Regulation (EU) № 528/2012;
13. Evaluation of applications for renewal of approval of an active substance for inclusion in the list of approved active substances in the European Union under Art. 14 of Regulation (EU) № 528/2012;
14. issuing a temporary permit and an extension of art. 55 (1) and (2) of Regulation (EU) № 528/2012;
15. authorization for the same biocidal product or a refusal under Art. 3 and 5 of Regulation (EU) № 414/2013 of 6 May 2013 for establishing a procedure for the authorization of identical biocidal products in accordance with Regulation (EU) № 528/2012 of the European Parliament and the Council (OB , L 125/4 of May 7, 2013), hereinafter referred to as "implementing Regulation (EU) № 414/2013";
16. authorization under Art. 18c, para. 5 or terminating the art. 18c, para. 4;
17. amendment of an authorization under Art. 18d para. 1 or revocation of an authorization under Art. 18e, para. 1;
18. a new permit available on the market of biocidal products, amending or repealing permits issued in the cases of art. 18g para. 1 and 2.

Art. 15a. (1) Meetings of the Board of art. 15, para. 1 are considered regularly conducted when more than half of its members.
(2) The Council of Art. 15, para. 1 makes proposals under Art. 15, para. 4 based on decisions adopted by a majority of more than half of the members present.
(3) members of the Board of art. 15, para. 1 are obliged not to divulge information that has become known to them during or in connection with their official duties, which constitutes industrial or commercial secret. They sign a declaration of confidentiality of data.
(4) The work of the Council under Art. 15, para. 1 is secured with funds from the budget of the Ministry of Health.
(5) The Minister of Health shall issue regulations for the organization and activities of the Council under Art. 15, para. 1.
(6) Regulations under par. 5 define the requirements for education and training of members of the Board of art. 15, para. 1.
Art. 16. Ministry of Health to establish and administer a national information bureau in accordance with Art. 81 (2) of Regulation (EU) № 528/2012 to provide advice to those available on the market of biocidal products on the occasion of their obligations under the implementation of the regulation.
Art. 17. (1) The Minister of Health gave an opinion on the conduct of research and development of art. 56 of Regulation (EU) № 528/2012, including experiments or tests unauthorized biocidal products or unapproved active substances where the environment is released or can be released biocidal product or active substance.
(2) The person who will carry out the experiment or the test under par. 1 prior written notify the Minister of Health, as the notification applies:
1. data under Art. 56 (2) of Regulation (EU) № 528/2012;
2. document fee paid under Art. 19, para. 1, p. 1.
Art. 17a. (1) The Minister of Health issued national authorization to provide the market of a biocidal product or a biocidal product family of art. 29 and 30 of Regulation (EU) № 528/2012.
(2) authorization under par. 1, the applicant shall submit an application to the Bulgarian language to which it applies:
1. details of the unique identifier of art. 23 of the Law on the commercial register or equivalent document for registration in accordance with the law of another Member - State of the Union or in accordance with the laws of another country - party to the Agreement on the European Economic Area;
2. documents under Art. 20 (1), letter "a" of Regulation (EU) № 528/2012, except in cases of art. 21 of Regulation (EU) № 528/2012; 3
. document fee paid under Art. 19, para. 1, p. 2.
Art. 17b. (1) The Minister of Health shall issue an authorization to provide market of biocidal products or of a biocidal product under a simplified procedure under Art. 26 of Regulation (EU) № 528/2012, if they meet the requirements of Art. 25 of Regulation (EU) № 528/2012.
(2) authorization under par. 1, the applicant shall submit an application to the Bulgarian language to which it applies:
1. details of the unique identifier of art. 23 of the Law on the commercial register or equivalent document for registration in accordance with the law of another Member - State of the Union or in accordance with the laws of another country - party to the Agreement on the European Economic Area;
2. documents under Art. 20 (1), letter "b" of the Regulation (EU) № 528/2012, except in cases of art. 21 of Regulation (EU) № 528/2012; 3
. document fee paid under Art. 19, para. 1, p. 3.
Art. 17c. (1) The Minister of Health renewed national authorization under Art. 17a, where the conditions under Art. 19 of Regulation (EU) № 528/2012.
(2) For renewal under par. 1 authorization holder shall submit an application to the Bulgarian language to which it applies:
1. details of the unique identifier of art. 23 of the Law on the commercial register or equivalent document for registration in accordance with the law of another Member - State of the Union or in accordance with the laws of another country - party to the Agreement on the European Economic Area;
2. documents under Art. 31 (3) of Regulation (EU) № 528/2012; 3
. document fee paid under Art. 19, para. 1, p. 4.
Art. 17d. (1) The Minister of Health shall issue an authorization to provide market of biocidal product or a biocidal product by subsequent mutual recognition of national authorization pursuant to Art. 33 of Regulation (EU) № 528/2012.
(2) authorization under par. 1 applicant or his representative shall submit to the Ministry of Health request of Bulgarian language, which applies to:

1. the authorization granted by the Member - State of the Union in which the biocidal product is authorized for the first time, accompanied by a translation into Bulgarian made by a translator entered into a contract with the Ministry of Foreign Affairs;
2. document fee paid under Art. 19, para. 1, p. 5.
Art. 17e. (1) The Minister of Health shall issue an authorization to provide market of biocidal product or a biocidal product through mutual recognition in parallel, when the Republic of Bulgaria was chosen as the reference member state under Art. 34 (1) of Regulation (EU) № 528/2012.
(2) authorization under par. 1 applicant or his representative shall submit to the Ministry of Health request of Bulgarian language to which it applies:
1. documents under Art. 34 (1), letters "a" and "b" of Regulation (EU) № 528/2012;
2. document fee paid under Art. 19, para. 1, p. 6.
(3) The Minister of Health shall issue an authorization to provide market of biocidal product or a biocidal product through mutual recognition in parallel, when the Republic of Bulgaria was elected the Member State concerned of art. 34 (1), letter "b" of the Regulation (EU) № 528/2012.
(4) authorization under par. 3 applicant or his representative shall submit to the Ministry of Health request of Bulgarian language to which it applies:
1. documents under Art. 34 (2) letters "a" and "b" of Regulation (EU) № 528/2012;
2. document fee paid under Art. 19, para. 1, p. 7.
(5) The permits under par. 1 and 3 are issued pursuant to Art. 34 of Regulation (EU) № 528/2012 for biocidal product or a biocidal product not yet authorized in accordance with Art. 17 of Regulation (EU) № 528/2012.
Art. 17f. (1) The Minister of Health at the request of the official or scientific bodies involved in pest control activities or the protection of public health, authorizes the provision of market biocidal product or a biocidal product authorized in another Member - State of the Union through mutual recognition of the authorization.
(2) authorization under par. 1 applicant or his representative shall submit to the Ministry of Health request of Bulgarian language to which it applies:
1. the authorization granted by the Member - State of the Union in which the biocidal product is authorized for the first time, accompanied by a translation into Bulgarian made by a translator entered into a contract with the Ministry of Foreign Affairs;
2. document fee paid under Art. 19, para. 1, p. 8.
(3) The permits under par. 1 issued pursuant to Art. 33 of Regulation (EU) № 528/2012.
Art. 17g. (1) The Minister of Health renewed authorization available on the market of a biocidal product or a biocidal product family of art. 17d and 17e under Delegated Regulation (EU) № 492/2014.
(2) The Minister of Health renewed authorization for the provision of market biocidal product or a biocidal products by subsequent or parallel mutual recognition when the Republic of Bulgaria was elected as Reference Member State.
(3) renewal under par. 2, the applicant or his representative shall submit to the Ministry of Health request of Bulgarian language to which it applies:
1. documents under Art. 2 of Delegated Regulation (EU) № 492/2014;
2. document fee paid under Art. 19, para. 1, p. 9.
(4) The Minister of Health renewed authorization for the provision of market biocidal product or a biocidal products by subsequent or parallel mutual recognition when the Republic of Bulgaria was elected the Member State concerned.
(5) authorization under par. 4 applicant or his representative shall submit to the Ministry of Health request of Bulgarian language to which it applies:
1. documents under Art. 2 of Delegated Regulation (EU) № 492/2014;
2. document fee paid under Art. 19, para. 1, p. 10.
Art. 17h. (1) The Minister of Health revoked or amended permits issued under Art. 17a, 17b, 17d and 17e at the request of the authorization holder in accordance with the requirements of Art. 49 and 50 of Regulation (EU) № 528/2012.
(2) amend the permit issued pursuant to Art. 17a, 17d and 17e authorization holder shall submit an application to the Bulgarian language to which it applies:
1. details of the unique identifier of art. 23 of the Law on the commercial register or equivalent document for registration in accordance with the law of another Member - State of the Union or in accordance with the laws of another country - party to the Agreement on the European Economic Area;
2. relevant documents in Art. 5-8 of Implementing Regulation (EU) № 354/2013; 3
. document fee paid under Art. 19, para. 1, p. 11.
(3) amend the permit issued pursuant to Art. 17b authorization holder or his representative shall submit a notification to the Bulgarian language in accordance with the requirements of Art. 9 of Regulation (EU) № 354/2013.

(4) The Minister of Health revoked or amended permits issued under Art. 17a, 17b, 17d and 17e in the cases of art. 48 (1) of Regulation (EU) № 528/2012 subject to the requirements of Art. 48 (2) and (3) of Regulation (EU) № 528/2012.
Art. 17i. (1) The Minister of Health shall issue an authorization to provide market identical biocide under Art. 2, 3 and 5 of Regulation (EU) № 414/2013.
(2) authorization under par. 1, the applicant shall submit an application to the Bulgarian language to which it applies:
1. documents under Art. 2 of Regulation (EU) № 414/2013;
2. document fee paid under Art. 19, para. 1, p. 12.
Art. 17k. (1) The Minister of Health shall issue a permit for parallel trade of biocidal product that is authorized in another Member - State of the European Union, and is identical to a biocidal product authorized in the Republic of Bulgaria under Art. 53 of Regulation (EU) № 528/2012.
(2) authorization under par. 1, the applicant shall submit an application to the Bulgarian language to which it applies:
1. documents under Art. 53 (4) of Regulation (EU) № 528/2012;
2. document fee paid under Art. 19, para. 1, p. 13.
Art. 17l. (1) The Minister of Health will evaluate the applications for issuance or renewal of a permit from the Union for the market of a biocidal product or a biocidal product family of art. 43 (1), (3) and (4) Art. 44 (1) and (2) and Art. 46 (1) and (2) of Regulation (EU) № 528/2012.
(2) The assessment under par. 1 is subject to the prior written consent of the Minister of Health to the applicant.
(3) For the assessment under par. 1 applicant shall pay a fee of art. 19, para. 1, p. 14.
Art. 17 m. (1) The Minister of Health will evaluate the applications for approval of an active substance for inclusion in the list of approved active substances in the European Union under Art. 9 (2) of Regulation (EU) № 528/2012 or for subsequent amendments to the conditions of approval of an active substance of art. 8 of Regulation (EU) № 528/2012.
(2) The assessment under par. 1 is subject to the prior written consent of the Minister of Health to the applicant.
(3) For the assessment under par. 1 applicant shall pay a fee of art. 19, para. 1, p. 15.
Art. 17H. (1) The Minister of Health shall issue a temporary permit to provide the market of biocidal product or a biocidal product of art. 55 (2) of Regulation (EU) № 528/2012 following an evaluation of the application under Art. 17 m.
(2) authorization under par. 1 applicant submit to the Ministry of Health an application in Bulgarian, enclosing document fee paid under Art. 19, para. 1, p. 16.
Art. 17o. (1) The Minister of Health at the proposal of the applicant and after having confirmed in writing to the applicant, carried out assessment of applications for renewal of approval of an active substance for inclusion in the list of approved active substances in the European Union under Art. 9 (2) of Regulation (EU) № 528/2012.
(2) For the assessment under par. 1 applicant shall pay a fee of art. 19, para. 1, p. 17.
Art. 17p. Applications and documents procedures Art. 17 - 17o be submitted to the Ministry of Health through the Register for Biocidal of art. 71 of Regulation (EU) № 528/2012.
Art. 17B. Biocidal products available on the market under art. 17a - 17n are classified, packaged and labeled in accordance with the provisions of art. 69 of Regulation (EC) № 528/2012 of the Bulgarian language.
Art. 18. (1) The Minister of Health may issue a permit to provide the market of biocidal product or a biocidal products containing:
1. existing active substance / existing active substances which are evaluated under Delegated Regulation (EU) № 1062/2014, but not yet approved for this product type;
2. existing active substance / existing active substances currently being evaluated under Delegated Regulation (EU) № 1062/2014, but not yet approved for this product type; 3
. combination of active substances referred to in paragraphs. 1 and 2, and active substances approved in accordance with Regulation (EU) № 528/2012.
(2) In the cases under par. 1 biocidal product is permitted when:
1. existing active substances in biocidal products are included in Annex II of the Delegated Regulation (EU) № 1062/2014 and no decision of the European Commission not to include them in the list of approved active substances in the European Union under Art. 9 (2) of Regulation (EU) № 528/2012;
2. the product type is included in Appendix II of the Delegated Regulation (EU) № 1062/2014 and no decision of the European Commission not to include him in the list of approved active substances in the European Union under Art. 9 (2) of Regulation (EU) № 528/2012;
3
. person is established within the European Union and manufactures or imports the active substance - alone or in biocidal products, or produced or made available biocide, which is composed of, containing or generating this substance, which is included in the list of the European Agency chemicals art. 95 (2) of Regulation (EU) № 528/2012, for the product type to which belongs biocide.
(3) Biocidal products that meet the criteria of art. 19 (4) of Regulation (EU) № 528/2012, does not allow for widespread use.
Art. 18a. Biocides of art. 18 are classified, packaged and labeled in accordance with Regulation (EC) № 1272/2008 (CLP) and Art. 69 of Regulation (EC) № 528/2012 of the Bulgarian language.
Art. 18b. (1) authorization under Art. 18 person who places on the market biocidal product or his representative shall submit to the Ministry of Health request of Bulgarian language to which it applies:
1. details of the unique identifier of art. 23 of the Law on the commercial register or equivalent document for registration in accordance with the law of another Member - State of the Union or in accordance with the laws of another country - party to the Agreement on the European Economic Area;
2. documents pursuant to Art. 95 (2) of Regulation (EU) № 528/2012, which can be letters of access under Art. 3 (1) letter "y" of Regulation (EC) № 528/2012, contracts, invoices and others; 3
. technical dossier of the product;
4. SDS under Art. 7b;
5. document fee paid under Art. 19, para. 1, p. 18.
(2) The documents under par. 1 pt. 3 and 4 are presented in the Bulgarian language, one copy - paper and triplicate - electronically, accompanied by a declaration of identity information submitted on paper and electronically.
Art. 18c. (1) Within 45 days from the date of receipt of the documents under Art. 18b para. 2 check completeness of data in them.
(2) Upon finding of incompleteness in the documents the Minister of Health shall notify the applicant and set a deadline for their removal.
(3) The Minister of Health may extend the term under par. 2 when the applicant presents a reasoned request.
(4) If the applicant fails to remedy any identified deficiencies in the documents within the period under par. 2 or 3, the procedure for authorization is terminated.
(5) The Minister of Health shall issue an authorization to provide market of biocidal product or a biocidal product in 60 days from the date of submission of documents under Art. 18b para. 2, respectively from the date of receipt of the information under par. 2 or 3.
Art. 18d. (1) The Minister of Health review the permit issued pursuant to Art. 18 in the case of:
1. new data on the effects of the active substance or biocidal product for humans or the environment;
2. request by the applicant; 3
. change in the commercial register of the person providing the market biocide;
4. changing packaging.
(2) In the cases under par. 1 the Minister of Health may require additional information and to modify the conditions of the permit issued.
(3) Amendment of the authorization is subject to the requirements of Art. 18 and upon payment of a fee of art. 19, para. 1, p. 19.
(4) Upon amendment of an authorization to provide market biocide Minister of Health may set a time limit for storage, use or distribution of stocks biocide.
Art. 18e. (1) The Minister of Health revoked the license issued under Art. 18 when:
1. applicant has submitted false and / or misleading data for the authorization;
2. active substance is banned for marketing and use in the European Union; 3
. It has received a reasoned request by the holder of the authorization.
(2) Before canceling the authorization under par. 1 Minister of Health shall notify the holder of the authorization.
(3) Upon revocation of an authorization to provide market of biocidal product or a biocidal Minister of Health may set a time limit for storage, use or distribution of stocks biocide.
Art. 18f. (1) The Minister of Health approved an order lists of active substances for which a decision of the European Commission that the active substance is not approved for inclusion in the list of approved active substances in the European Union under Art. 9 (2) of Regulation (EU) № 528/2012.
(2) The order under par. 1 is published in the "Official Gazette" and published on the Ministry of Health on the Internet.

Art. 18g. (1) Where a decision by the European Commission for approval of an active substance for inclusion in the list of approved active substances in the European Union under Art. 9 (2) of Regulation (EU) № 528/2012, Minister of Health issued a new authorization for the provision of market biocide, amend or revoke the license issued under Art. 18.
(2) Where a decision of the European Commission that the active substance is not approved for inclusion in the list of approved active substances in the European Union under Art. 9 (2) of Regulation (EU) № 528/2012 for certain or all of the notified product types, Minister of Health, amend or revoke issued under Art. 18 authorization in accordance with Commission Delegated Regulation (EU) № 1062/2014 and art. 89 (2) of Regulation (EU) № 528/2012.
(3) The issuance of a new permit modification or revocation of the permit issued pursuant to Art. 18 is carried out in accordance with the decision of approval or non-approval of an active substance in the list of approved active substances in the European Union under Art. 9 (2) of Regulation (EU) № 528/2012.
Art. 18h. An ordinance of the Council of Ministers to determine the form and content:
1. technical documentation and documents that the applicant shall submit authorization to provide the market of a biocidal product or a biocidal product family of art. 18;
2. issued permits available on the market of biocidal product or a biocidal product of art. 18.
Art. 18i. (1) The Ministry of Health keeps a register of authorized biocidal products under Art. 18. The register is public and contains:
1. number and date of the authorization to provide the market of the product;
2. validity of the authorization issued if any; 3
. data on the person providing the market biocide - name, registered office and address;
4. name of the product;
5. name and concentration of active substance / active substances contained in the biocidal products;
6. type of biocide and scope;
7. category of use;
8. date of cancellation of the authorization;
9. changes in the circumstances under item. 1 - 7.
(2) The register under par. 1 was formed separate section in which the order of submission fit persons applied for authorization to provide the market of biocidal product and describe the number and type of documents attached to the application. This section notes the movement of the file compiled by the application.
(3) The ordinance under Art. 18h define the conditions and procedure for keeping the register under par. 1.
Art. 19. (1) tariff of art. 46 of the Health Council of Ministers determines state charges:
1. an opinion to conduct research and development of art. 17;
2. a national authorization to provide market biocidal product or a biocidal product or a biocidal product of art. 17a; 3
. authorization to provide market biocidal product or a biocidal product under a simplified procedure under Art. 17b;
4. renewal of a national authorization to provide market of biocidal product or biocidal product family of art. 17c;
5. authorization to provide market biocidal product or a biocidal product by subsequent mutual recognition in art. 17d;
6. authorization to provide the market of a biocidal product or a biocidal product through mutual recognition in parallel of art. 17e, para. 1;
7. authorization to provide the market of a biocidal product or a biocidal product through mutual recognition in parallel of art. 17e, para. 3;
8. authorization to provide the market of a biocidal product or a biocidal product through mutual recognition of art. 17f;
9. renewal of the authorization to provide the market of biocidal product or biocidal product family of art. 17d and 17e, when the Republic of Bulgaria was chosen as the reference Member State;
10. renewal of the authorization to provide the market of biocidal product or biocidal product family of art. 17d and 17e, when the Republic of Bulgaria was elected the Member State concerned;
11. amending allowed to provide the market of biocidal product or biocidal product family of art. 17a, 17d and 17e;
12. authorization to provide market identical biocide under Art. 17i;
13. authorization for parallel trade of biocide under Art. 17k;
14. Evaluation of applications for issuance or renewal of an authorization from the Union for the market of a biocidal product or a biocidal product of art. 17l;
15. Evaluation of applications for approval of an active substance of art. 17 m;
16. granting provisional authorization to provide the market of biocidal product or a biocidal product of art. 17H;
17. Evaluation of applications for renewal of approval of an active substance of art. 17o;
18. authorization to provide the market of a biocidal product or a biocidal product family of art. 18;
19. change allowed to provide the market of biocidal product or biocidal product family of art. 18;
20. authorization under Art. 30 para. 5.

(2) Funds from fees under par. 1 shall be entered as revenue in the budget of the Ministry of Health.
Art. 19a. Minister of Health sent a report on the implementation of Regulation (EU) № 528/2012 to the European Commission in accordance with Art. 65 (3) of that Regulation. "
§ 7. In art. 21 is amended as follows:
1. In para. 2 words "and the National Center for Public Health" is replaced by "National Center for Public Health and Analysis and the Executive Environment Agency."
2. Paragraph 10 is amended as follows:
"(10) The work of the expert council shall be ensured:
1. for the assessment under par. 6 - with funds from the European Chemicals Agency, in accordance with Art. 14 (1) of Regulation (EC) № 340/2008 of 16 April 2008 on fees and charges payable to the European Chemicals Agency, in accordance with Regulation (EC) № 1907/2006 of the European Parliament and the Council concerning the registration, evaluation, Authorisation and restriction of chemicals (REACH) (OJ, L 107/6 of April 17, 2008);
2. in drafting a motivated proposal and consideration of proposals under par. 7 and 9 - with funds from the budget of the Ministry of Environment and Water. "
§ 8. In art. 21b para. 2 words "National Center for Public Health" is replaced by "National Center for Public Health and Analysis".
§ 9. In art. 21c make the following changes and additions:
1. In para. 1 after the words "market mixes" a comma and added "in t. H. Biocides."
2. Paragraph 3 is amended as follows:
"(3) The information under par. 1 is presented before the first marketing of chemical mixtures importers or downstream users. "
Third. In para. 6, after the word "mixed" a comma and added "in t. H. With biocides."
§ 10. In art. 21e be made the following amendments:
1. In para. 2 t. 3 is repealed.
2. Created al. 3 and 4:
"(3) The Minister of Environment and Water approve an order exemptions from restrictions on the use of hazardous substances in certain materials and components of EEE.
(4) Zapovedite under par. 3 are published in the "Official Gazette" and published on the website of the Ministry of Environment and Water. "
§ 11. In the title of Chapter Six words" Regulation № (EC) 689/2008 "are replaced by" Regulation (EU) № 649/2012 ".
§ 12. In art. 22 words "Regulation (EC) № 689/2008" are replaced by "Regulation (EU) № 649/2012".
§ 13. Article 22 is amended as follows:
"Art. 22a. (1) Before the first annual export of a dangerous chemical substance on its own or in a mixture according to Art. 8 (2) of Regulation (EU) № 649/2012, or in a product according to Art. 15 (1) of Regulation (EU) № 649/2012 exporter shall submit to the Ministry of Environment and Water export notification electronically via the database of the European Chemicals Agency in accordance with the deadline and in the format specified in Art. 8 (2) of Regulation (EU) № 649/2012.
(2) The notification under par. 1 applies SDS chemical or mixture prepared in accordance with Annex II of Regulation № (EO) 1907/2006 (REACH) and Art. 17 (4) of Regulation (EU) № 649/2012.
(3) For errors and omissions in the notification under par. 1 Minister of Environment and Water or an authorized officer shall so inform the exporter through the database of the European Chemicals Agency within 5 days from the date of submission of information under Art. 8 (2) of Regulation (EU) № 649/2012.
(4) The exporter removes errors and omissions in 5 days from the date of receipt of the notification under par. 3.
(5) Exports of chemicals from Parts 2 and 3 of Annex I to Regulation (EU) № 649/2012 is subject to a written consent of the competent authorities of the destination countries.
(6) processing of the notification under par. 1, the exporter pays a fee pursuant to Art. 8 (8) of Regulation (EU) № 649/2012 according to the tariff of art. 72 of the Law on Environmental Protection. "
§ 14. Article 22b is repealed.
§ 15. Article 22c is repealed.
§ 16. In art. 22d is amended as follows:
1. In para. 1, 'Regulation (EC) № 689/2008 under Art. 21 of the Regulation "is replaced by" Regulation (EU) № 649/2012 under Art. 22 (1) of the regulation. "
2. In para. 2 words "Art. 17 of Regulation (EC) № 689/2008 "are replaced with" Art. 18 of Regulation (EU) № 649/2012 ". 3
. In para. 3:
a) t. 1, 'Regulation (EC) № 689/2008 "are replaced by" Regulation (EU) № 649/2012 ";
B) in item. 3 the word "registered" shall be deleted and the words "Art. 7 and art. 13 (6) of Regulation (EC) № 689/2008 "are replaced with" Art. 8 and Art. 14 (6) of Regulation (EU) № 649/2012 ".
§ 17. In art. 22e everywhere the words "Regulation (EC) № 689/2008" are replaced by "Regulation (EU) № 649/2012", and the words "Art. 9 "are replaced by" Art. 10 '.
§ 18. In art. 22g creates par. 3:

"(3) The holder of stocks in quantities of 50 kg of hazardous substances from Annex I and / or Annex II of Regulation (EC) № 850/2004, whose use is authorized to submit to the Minister of Environment and Water Information the nature and amount of these stocks and measures for their safe storage within the time limits specified in Art. 5 (2) of Regulation (EC) № 850/2004. "
§ 19. After Art. 22g creates Chapter Six "a" new art. 23, 24, 24a and Art. 24b:
"Chapter Six" and "
MEASURES FOR THE IMPLEMENTATION OF REGULATION (EC) № 98/2013
Art. 23. explosives precursors under restriction within the meaning of Art. 3, p. 10 of Regulation (EU) № 98/2013 does not provide, implement, own or use by the general public.
Art. 24. In accordance with Art. 5 of Regulation (EC) № 98/2013 traders labeled or shall ensure that a label of explosives precursors under restriction stating that the purchase, possession or use of explosives precursors under restriction by the general public it is prohibited.
Art. 24a. (1) The Ministry of Interior is a national contact point within the meaning of Art. 9 (2) of Regulation (EC) № 98/2013.
(2) Traders report to the national contact point under par. 1 all suspicious transactions or attempted such significant losses or thefts of the substances listed in Annex I and Annex II of Regulation (EC) № 98/2013, in accordance with the provisions of art. 9 (3) and (4) of that Regulation.
(3) Reporting under par. 2 is carried out in compliance with the Law on Protection of Personal Data.
Art. 24b. Obligations under Art. 9 (6) of Regulation (EC) № 98/2013 implemented through providing access to guidelines for the application of the European Commission of the regulation on the websites of the Ministry of Health and the Ministry of Interior. "
§ 20. the name of Chapter VII is amended as follows: "Control of chemical substances on their own, in the composition of mixtures and in articles."
§ 21. In art. 25 be made the following amendments:
1. A t. 2a:
"2a. labeling of explosives precursors under restriction under Regulation (EC) № 98/2013; ".
2. In t. 12, 'Regulation (EC) № 689/2008 "are replaced by" Regulation (EU) № 649/2012 ". 3
. In pt. 13, the words "Regulation (EC) № 689/2008" are replaced by "Regulation (EU) № 649/2012".
4. A t. 14:
"14a. prohibition of explosives precursors under restriction to the general public in accordance with Art. 23; ".
5. A t. 17:
"17a. limiting the use of phosphates and other phosphorus compounds in consumer laundry detergents and consumer automatic dishwasher detergents under Regulation (EU) № 259/2012; ".
6. Section 20 is amended as follows:
"20. available on the market and professional use of biocides. "
7. Created so. 20a and 20b:
"20a. accordance with Art. 95 (2) of Regulation (EU) № 528/2012;
20b. placing on the market of treated articles; ".
8. In item. 22 the word "released" is replaced by "granted".
9. A t. 25:
"25. reporting of suspicious transactions or attempted ones and significant losses or thefts of the substances listed in Annex I and Annex II of Regulation (EC) № 98/2013. "
§ 22. In art. 27 be made the following amendments:
1. In para. 1 the number "17" is replaced by "17".
2. Paragraph 2 is amended as follows:
"(2) The bodies of the state health control under the health exercise control in the cases of art. 25 pt. 1, 2, 2a, 7, 10, 14 and 18-22 in order to protect public health. "
Third. A par. 8:
"(8) In the cases of art. 25 pt. 25 Minister of Interior or officials authorized by him shall exercise control under the Ministry of the Interior. "
§ 23. In art. 28 be made the following amendments:
1. In para. 3 everywhere words "Regulation (EC) № 689/2008" are replaced by "Regulation (EU) № 649/2012".
2. Paragraph 6 is amended as follows:
"(6) Where it is established that marketed chemical substance on its own, consisting of a mixture or in an article mixture and / or the biocidal product does not comply with the provisions of this Act, regulations acts on its application and / or regulations specified in Art. 1 pt. 3 and substance, mixture and / or the biocidal product presents a risk to the health and safety of persons and / or the environment, the Minister of Health and / or the Minister of Environment and Water or authorized by them officials may order the immediate and effective withdrawal of the substance or mixture and / or biocidal product from the market at the expense of those responsible for placing on the market or seizure by the end user. "
third. In para. 7 finally added "and / or the environment."
§ 24. In art. 30 is amended as follows:
1. In para. 3, 'or registered biocidal product "are deleted.

2. In para. 5, first sentence the words "marketing" are replaced by "the manner and within the period provided for in Art. 55 (1) of Regulation (EU) № 528/2012 available on the market or use "and the second sentence is deleted. 3
. Paragraph 7 is repealed.
4. In para. 8, the words "according to the tariff of art. 19y, para. 1 pt. 26 "are replaced by" Art. 19, para. 1, p. 20 ".
5. Paragraphs 9 and 10 are canceled.
§ 25. A Art. 30a:
"Art. 30a. (1) The Minister of Health at the proposal of the Minister of Interior may temporarily prohibit or restrict supply, possession and use of substances not included in Annex I and Annex II of Regulation (EC) № 98/2013, in accordance with art. 13 (1) of the regulation.
(2) The Minister of Health at the proposal of the Minister of Interior may further restrict or prohibit the provision, possession and use of substances in Annex I and Annex II of Regulation (EC) № 98/2013 in accordance with Art. 13 (2) and (3) of that Regulation.
(3) In applying the measure under par. 1 and / or par. 2 Minister of Health immediately inform the European Commission and other Member States, stating the reasons for its decision. "
§ 26. A new art. 31:
"Art. 31. The control of Regulation (EU) № 528/2012 is carried out in compliance with the requirements of Regulation (EC) № 765/2008. "
§ 27. In art. 33 is amended as follows:
1. In para. 1 after the word "chemicals" a comma and the words "and / or mixtures" are replaced by "mixtures and / or products".
2. Paragraph 2 is amended as follows:
"(2) The directors of the regional health inspection in accordance with its powers stop marketing and / or use of chemical substances, mixtures in t. H. Biocides and / or articles."
§ 28. In art. 35 be made the following amendments:
1. In para. 1:
a) in item. 3, after the words "Art. 7f par. 1 "is added" of this law "and the words" Art. 14f and art. 15 "shall be replaced with" Art. 16 and Art. 56 (1) of Regulation (EU) № 528/2012 ";
B) pt. 4, after the words "Art. 4 "insert" of this law "and the words" Art. 19sh "are replaced by" Art. 72 of Regulation (EU) № 528/2012 ";
C) t. 20 the word "run" is replaced by "providing";
D) point 21 shall be amended as follows:
"21. It is a professional user and biocide used without authorization issued; "
e) in Item. 22 words" basic substances for biocidal use "be replaced with" active substances "and the words" under Art. 14, para. 4 pt. 3 "are replaced by" of approved active substances in the European Union under Art. 9 (2) of Regulation (EU) № 528/2012 ";
E) in Item. 23 words "authorized" are replaced by "notified"
G) point 24 shall be amended as follows:
"24. launches treated article does not meet the requirements of Art. 58 of Regulation (EU) № 528/2012; "
h) point 25 shall be amended as follows:
" 25. available on the market biocide in violation of the conditions of the permit issued; "
) point 26 shall be amended as follows:
" 26. defaults for storing and providing information in accordance with Art. 68 (1) of Regulation (EU) № 528/2012; "
k) are created so. 26a and 26b:
" 26a. not fulfill its obligations to provide information under Art. 73 of Regulation (EU) № 528/2012;
26b. not fulfill its obligations to limit vertebrate animal testing according to Art. 62 of Regulation (EU) № 528/2012; "
l) the item. 27a:
" 27a. violates the restrictions on the use of phosphates and other phosphorus compounds in consumer laundry detergents and consumer automatic dishwasher according to Art. 4a of Regulation (EU) № 259/2012; "
m) in Item. 35 the words" Art. 7 and art. 14 (1) of Regulation (EC) № 689/2008 "are replaced with" Art. 8 and Art. 15 (1) of Regulation (EU) № 649/2012 ";
N) in Item. 36 the words "Art. 13 of Regulation (EC) № 689/2008 "are replaced with" Art. 14 of Regulation (EU) № 649/2012 ";
O) in Item. 37 the words "Art. 14 (2) of Regulation (EC) № 689/2008 "are replaced with" Art. 15 (2) of Regulation (EU) № 649/2012 ";
N) in Item. 38 the words "Art. 9, 15 and 16 of Regulation (EC) № 689/2008 "are replaced with" Art. 10, 16 and 17 of Regulation (EU) № 649/2012 ";
Q) are created ie. 40, 41 and 42:
"40. violates the prohibition of explosives precursors under restriction to the general public;
41. fails labeling of explosives precursors under the restriction of Art. 24;
42. fails to report suspicious transactions or attempted such significant losses or thefts of the substances listed in Annex I and Annex II of Regulation (EC) № 98/2013. "
2. In para. 3:
a) t. 1, 'and 33 "are replaced by" 33 and 40 ";
B) in item. 2 after the number "21" a comma and add "24, 26a, 26b"
C) in item. 3 after the number "27" add "27a" and a comma and the words "and 39" are replaced by "39, 41 and 42".
§ 29. In art. 36 be made the following amendments:
1. Paragraph 1 shall be amended as follows:

"(1) Violations of Art. 35, para. 1, p. 1-41 are established by acts issued by state health inspectors or officials designated by the Minister of Environment and Waters in accordance with their powers. "
2. Paragraph 2 is amended as follows:
"(2) The penalty shall be issued by the Director of the Regional Health Inspectorate or the Minister of Environment and Water or authorized by officials in accordance with their powers."
3 . A par. 4:
"(4) The acts for establishing the offenses under Art. 35, para. 1, p. 42 was drawn up by officials appointed by the Minister of Interior, and the penalty shall be issued by the Minister of Interior or authorized by officials. "
§ 30. In the Supplementary Provisions shall be amended and additions:
1. In § 1:
a) point 6 is amended as follows:
"6. "Hazardous chemical substances and mixtures" are chemical substances and mixtures that are classified as hazardous in one or more hazard categories listed in Annex № I of Regulation (EC) № 1272/2008 (CLP). ";
B) paragraph 19 shall be repealed;
C) points 25, 26 and 27 shall be repealed;
D) paragraph 29 shall be repealed;
E) Section 39 is repealed.
2. A new § 1a:
"§ 1a. (1) For the purposes of Chapters fourth, seventh and eighth, the definitions in Regulation (EU) № 528/2012.
(2) For the purposes of Chapter Six "and" the definitions in Regulation (EC) № 98/2013. "
Third. The former § 1a becomes § 1b.
Transitional and Final Provisions
§ 31. In the Law on Consumer Protection (prom. SG. 99 of 2005 .; amend., SG. 30, 51, 53, 59, 105 and 108 2006 pcs. 31, 41, 59 and 64 of 2007, pcs. 36 and 102 in 2008, pcs. 23, 42 and 82 of 2009, pcs. 15, 18 and 97 of 2010 ., No. 18 of 2011, pcs. 38 and 56 of 2012, pcs. 15, 27 and 30 of 2013, pcs. 61 of 2014 pcs. 14, 57 and 60 of 2015 .) Art. 82 is amended as follows:
1. In para. 1:
a) in item. 3, after the word "products" text until the end shall be deleted;
B) paragraph 5 is amended as follows:
"5. control bodies under the Protection from harmful effects of chemical substances and mixtures - in terms of restrictions on the marketing and use of certain dangerous substances, mixtures and articles in order to protect human health; "
c) section 6 is repealed .
2. In para. 2 words "item. 2-6 "are replaced by" item. 2-5. " 3
. In para. 4 words "item. 2-6 "are replaced by" item. 2-5. "
§ 32. (1) issued before the enactment of this Act under the repealed Art. 19d para. 1 permits the marketing of biocides remain valid until the expiration of the term for which they are issued, subject to the terms of the authorization.
(2) The persons holding permits than those under par. 1 filed within one month from the entry into force of this Act the Ministry of Health documents proving that the supplier of the active substances or supplier of biocide is included in the list of the European Chemicals Agency under Art. 95 (1) of Regulation (EC) № 528/2012 of product types, which include the biocide that may be letters of access under Art. 3 (1) letter "y" of the regulation, contracts, invoices and others.
(3) If within one month from the entry into force of this law, persons other than those under par. 1, do not submit the documents under par. 2 or submitted documents do not prove that the supplier of substances or supplier of biocide is included in the list of the European Chemicals Agency under Art. 95 (1) of Regulation (EU) № 528/2012, Minister of Health revoked the license issued to market a biocide.
(4) issued before the enactment of this law permits the placing on the market of biocidal products other than those under par. 1 which is submitted under par. 2 remain valid until the expiration of the term for which they are issued, subject to the terms of the authorization.
§ 33. (1) Persons who until the entry into force of this Act have allowed for placing on the market of biocidal products consisting of mixtures within the meaning of Regulation (EC) № 1272/2008 (CLP) and classified according to the requirements of Regulation under Art. 5 para. 2, submitted to the Ministry of Health an application for amendment of the authorization within June 1, 2017, enclosing:
1. proposal for classification and labeling of the biocidal product under Regulation (EC) № 1272/2008 (CLP);
2. a summary of the reasons for the proposed classification and labeling of the biocidal product, including methods used, data, calculations, and other criteria; 3
. documents confirming all data on chemical substances and biocidal products referred to in the summary, including test reports Safety Data Sheets in accordance with Annex II of Regulation (EC) № 1907/2006 and others;
4. Declaration of identity of the chemical composition and all other data for the biocidal product with the composition and the data on which the first license was issued;
5. draft label for the biocidal product on the Bulgarian language;

6. SDS biocidal products on the Bulgarian language in accordance with Annex II of Regulation (EC) № 1907/2006.
(2) The documents under par. 1 is presented in the Bulgarian language, one copy - paper and triplicate - electronically, accompanied by a declaration of identity of the information - paper and electronic.
(3) issued before the enactment of that law, for which the deadline under par. 1 applied for an amendment to the authorization remain valid under the conditions for authorization.
(4) The Minister of Health repealed issued before the enactment of that law, for which the deadline under par. 1 not applied for amendment.
(5) The Minister of Health review the permits issued under par. 1 in the cases and pursuant to Art. 18d.
§ 34. The provision of Art. 18i para. 2 applies after the establishment of the necessary technical and organizational conditions.
§ 35. Within three months of the entry into force of this Act the Council of Ministers brought the ordinance of art. 21e, para. 1 thereunder.
The law was adopted by the 43rd National Assembly on December 16, 2015 and was affixed with the official seal of the National Assembly.
Chairman of the National Assembly Tsetska Tsacheva
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