Law Amending The Law On Protection From The Harmful Effects 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

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Name of law Law amending and supplementing the law on protection from the harmful effects of chemical substances and mixtures Name Bill a bill amending and supplementing the law on protection from the harmful effects of chemical substances and mixtures, date of acceptance 18/10/2012 number/year Official Gazette 84/2012 Decree No 372

On the grounds of art. 98, paragraph 4 of the Constitution of the Republic of Bulgaria

I DECLARE:

To be published in the Official Gazette the law amending the law on protection from the harmful effects of chemical substances and mixtures, adopted by the National Assembly of the HLI 18 October 2012.

Issued in Sofia on October 26, 2012.

The President of the Republic: Rosen Plevneliev

Stamped with the State seal.

Minister of Justice: Diana Kovatcheva

LAW

amending the law on protection from the harmful effects of chemical substances and mixtures (promulgated, SG. 10 of 2000; amend., SG. 91 of 2002, 86/114 and 2003/100 and 101 from 2005, issue 30, 34, 80 and 95 from 2006, 53/82 and from 2007, 110/2008 and no. 63 and 98 of 2010.)

§ 1. In art. 1 item 4 is created:

"4. the restriction of use of hazardous substances in electrical and electronic equipment (EEO) in order to protect human health and the environment, including the environmentally sound recovery and disposal of waste from EEE and the related obligations of economic operators of the Eee.

§ 2. In art. 21, para. 7 item 4 is created:

4. restrict the use of a substance or group of substances in EEE. "

§ 3. A chapter 5 ' a ' with art. 21 e-21 (l):

"Chapter five" a "

RESTRICTION OF HAZARDOUS SUBSTANCES IN ELECTRICAL AND ELECTRONIC EQUIPMENT

Art. 21 (1) the terms and conditions for the placing on the market of the EEE in connection with restrictions on the use of certain hazardous substances shall be determined by an Ordinance of the Council of Ministers.

(2) the Ordinance referred to in para. 1 shall be determined:

1. the obligations of economic operators to ensure compliance with restrictions on the use of hazardous substances in EEE on the market play;

2. the conditions for the granting, renewal or revocation of the exemption from restrictions on the use of certain hazardous substances in EEE;

3. the cases of exemption from the restrictions on the use of hazardous substances in specific materials and components of EEE;

4. hazardous substances in EEE, whose use is subject to the limit, and the limit values of concentration of weight in homogenous materials contained in EEE;

5. the requirements for marking and labelling of EEE;

6. the procedure for assessment of conformity with the limitations on the use of hazardous substances in EEE and the contents of the Declaration of conformity.

Art. 21. (1) the EEC market Play must not contain dangerous substances above the limit concentrations determined by the Ordinance under art. 21 (e), para. 1.

(2) paragraph 1 shall apply to the following categories of EEE, including cables and spare parts for its repair, its reuse, updating of its functional features or enhance capacity:

1. large household appliances;

2. small household appliances;

3. it and telecommunications equipment;

4. consumer equipment;

5. lighting equipment;

6. electrical and electronic tools;

7. toys, leisure and sports equipment;

8. medical devices under art. 2, al. 1, paragraphs 1 and 3 of the law on medical devices;

9. monitoring and control instruments, including industrial monitoring and control instruments;

10. automatic dispensers;

11. another EEE, which is not included in the categories referred to in item 1-10.

(3) paragraph 1 shall not apply to:

1. equipment that is necessary for the protection of the essential interests of the Republic of Bulgaria relating to national security, including weapons, ammunition and combat products specially designed for military use;

2. equipment intended to send into outer space;

3. equipment which is specially designed and installed as part of another type of equipment that is excluded from or does not fall within the scope of this chapter, which can perform its intended only as part of this equipment and may be replaced only with the same specially designed equipment;

4. large units stationary industrial equipment;

5. large stationary installations;

6. means of transport of passengers or goods with the exception of electric two-wheel motor vehicles that have not received type-approval;

7. mobile devices, which are not intended for use on the roads provided exclusively for professional use;

8. active implantable medical devices referred to in art. 2, al. 1, item 2 of the law on medical devices;

9. photovoltaic panels intended for use in a system that is designed, created and installed by professionals for permanent operation at a certain location in order to produce energy from sunlight for public, commercial, industrial and domestic needs;

10. equipment specially designed for the purposes of research and development and provided only to the principle of associated business systems.

Art. 21. (1) a manufacturer of EEE shall assess the compliance of the product with the provisions of art. 21, para. 1 and it authenticates with the CE marking and Declaration of conformity in accordance with the requirements of the Ordinance under art. 21 (e), para. 1.


(2) the CE marking shall be affixed in accordance with the General principles laid down in art. 30 of Council Regulation (EC) no 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ, L 218/30 of 13 August 2008), hereinafter referred to as "Commission Regulation (EC) no 765/2008".

(3) where on the EEE bear the CE marking, it is believed that this EEE contains hazardous substances in homogeneous materials over the limit weight concentrations determined by the Ordinance under art. 21 (e), para. 1, unless there is evidence to the contrary.

Art. 21. (1) electrical and electronic equipment and materials and components of EEE which they have successfully passed tests or measurements, demonstrating compliance with the provision of art. 21, para. 1, or have been assessed in accordance with the harmonised standards whose name and number are published in the official journal of the European Union, it shall be deemed to comply with the use restrictions of hazardous substances.

(2) where it finds that a harmonised standard referred to in paragraph 1. 1 do not ensure compliance with the requirements of art. 21, para. 1, the State Agency for metrological and technical surveillance and, in the case of EEE under art. 21, para. 2, item 8 – drug agency, shall inform the Committee set up pursuant to art. 5 of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services.

Art. 21. (1) the Minister of the environment and water or an official authorised by him will make a proposal to the European Commission to limit the substance or group of substances in EEE:

1. evaluation of the priority substances, carried out in accordance with art. 45 of Regulation (EO) No 1907/2006 REACH and by the procedure of art. 21 or by another Member State of the European Union or other State – party to the agreement on the European economic area;

2. identification of hazardous substances pursuant to art. 59 (3) of the Regulation (EO) No 1907/2006 REACH;

3. the restriction of hazardous substances in accordance with art. 69 (4) of Regulation (EO) No 1907/2006 REACH.

(2) a proposal under paragraph 1. 1 contains:

1. precise and clear wording of the proposed restriction;

2. information and scientific evidence for the proposed restriction;

3. information on the use of the substance or group of substances in EEE;

4. information on the harmful effects and exposure to dangerous effects, in particular during activities on the management of waste from EEE;

5. information on the availability and reliability of the alternatives and other alternatives;

6. justification for the need to impose a constraint at the level of the European Union as the most appropriate measure;

7. the socio-economic evaluation of the proposed restriction.

Art. 21 HP (1) not later than 31 March, the President of the State Agency for metrological and technical surveillance and the Executive Director of the drug agency authorized by or submitted to the Minister of environment and water summary information about the controls carried out on the implementation of the provisions of this chapter and of the Ordinance under art. 21 (e), para. 1.

(2) the information referred to in para. 1 is used for the preparation of an assessment of the implementation of this chapter and of the Ordinance under art. 21 (e), para. 1.

Art. 21 l. the provisions of this chapter shall apply, without conflict with the requirements of the Regulation (EO) No 1907/2006 (REACH) Regulation (EO) No 850/2004 and the requirements in the field of safety and health and waste management. "

§ 4. In art. 25 t be created. 23 and 24:

"23. play of the market the EEE under art. 21, para. 2, item 1-7 and 9-11, defined in Chapter five "a" in the Ordinance under art. 21 (e), para. 1;

24. play EEE on the market under art. 21, para. 2, item 8 specified in Chapter five "a" in the Ordinance under art. 21 (e), para. 1. "

§ 5. In art. 26, al. 6, after the words "art. 27 "a comma and added al. 1, 2 and 4.

§ 6. In art. 27 create al. 6 and 7:

"(6) in the cases under art. 25, p. 23, Chairman of the State Agency for metrological and technical surveillance or authorised by officials exercising market supervision pursuant to chapter IV of the law on technical requirements for products and in accordance with Chapter III of Regulation (EC) no 765/2008.

(7) in the cases under art. 25, t. 24 the Executive Director of the drug agency or authorised by officials exercising market supervision in accordance with Chapter vi of the law for medical devices and in accordance with Chapter III of Regulation (EC) no 765/2008. "

§ 7. In art. 35 following amendments and supplements shall be made:

1. In paragraph 8. 1 t. 39 is created:

"39. break the requirements of Chapter five" a "or of the Ordinance under art. 21 (e), para. 1 for:

a) restricting the use of hazardous substances in EEE and the cables and spare parts for its repair, its reuse, updating of its functional characteristics or increased capacity;

(b) conformity assessment) with restrictions on the use of hazardous substances in EEE or preparation of the technical documentation or a declaration of conformity;

in the map) "" marking and tagging of the Eee and the cables and spare parts for its repair, its reuse, updating of its functional characteristics or increased capacity;

d) maintaining and providing information for attesting the conformity of an EEE on the market operating released with restrictions on the use of hazardous substances. "

2. in the Al. 3, paragraph 3, the words "35 and 38" is replaced by "35, 38 and 39.


§ 8. In art. 36 following amendments and supplements shall be made:

1. In paragraph 8. 1 the words "art. 35 "is replaced by" article. 35, para. 1, item 1 – 38 ".

2. a para. 3:

"(3) the acts of violation under art. 35, para. 1 39 shall be drawn up by officials as determined by the President of the State Agency for metrological and technical supervision or by the Executive Director of the drug agency, in accordance with their powers, and the penal provisions shall be issued by the Chairman of the State Agency for metrological and technical supervision or by the Executive Director of the drug agency, in accordance with their authority or by officials authorised by them. "

§ 9. In the additional provision, the following amendments and supplements shall be made:

1. The title shall be replaced by the following: "additional provisions".

2. In paragraph 1 shall be established that 41-64:

"41." electrical and electronic equipment (EEE) "is equipment that needs an electrical current or electromagnetic fields to perform at least one of the features they use, as well as equipment for the generation, transfer and measurement of such currents or fields, and is designed for use with a voltage not exceeding 1000 Volts for alternating current and 1500 volts for direct current.

42. big unit stationary industrial equipment "is a large set of machines, equipment and components, operating jointly with the specific application installed and dismantled permanently by specialists in a given place and operated and maintained by specialists in industrial production buildings or facilities for research and development.

43. "fixed installation" is a great combination of several types of apparatus and, where applicable, other devices, which are assembled, installed and removed by professionals and are designed for permanent operation of the predetermined location.

44. "Cables" are all the cables with a rated voltage of less than 250 volts, serving for connection or extension cord connecting the EEE with mains or when connecting two or more EEE.

45. "a manufacturer of EEE ' means any natural or legal person who manufactures an EEE or EEE designed or has produced and marketed under their own name or trademark.

46. "authorised representative" means any natural or legal person established in the territory of a Member State of the European Union or of another State party to the agreement on the European economic area, which has received a written mandate from a manufacturer of EEE to act on his behalf for the implementation of certain obligations under the Ordinance under art. 21 (e), para. 1.

47. "distributor of EEE ' means any natural or legal person in the supply chain, other than the manufacturer or the importer, who provides EEE on the market.

48. "importer of EEE ' means any natural or legal person established in the territory of a Member State of the European Union or of another State party to the agreement on the European economic area, which it places on the market of the European Union the EEE from a third country.

49. "economic operator" is a manufacturer, importer and distributor of the Eee or authorized representative.

50. "making available on the market of the Eee is any gainful or gratuitous supply of an EEE for distribution, consumption or use on the market of the European Union as part of a commercial activity.

51. "placing on the market of the Eee" is providing the EEE market of the European Union for the first time.

52. "harmonised standard" means a standard adopted by a European standards organisation in the implementation of the mandate of the European Commission in accordance with art. 6 of Directive 98/34/EC.

53. "CE" marking, is a manufacturer of EEE certifies that the product complies with the applicable requirements of the legislative acts of the European Union for harmonisation, providing for the application.

54. "conformity assessment" is a procedure by means of establishing whether the requirements of Chapter five "a" and of the Ordinance under art. 21 (e), para. 1 in the case of an Eee.

55. "Homogeneous material" is a material with or entirely homogenous, or material, consisting of a combination of materials which cannot be decomposed of different materials by mechanical actions such as razvintvane, slicing, shredding, grinding and abrasive technologies.

56. "medical device" e medical device within the meaning of § 1, item 21 of the additional provisions of the law for medical devices, which is the Eee.

57. "in vitro diagnostic medical device ' e medical device within the meaning of § 1, item 12 of the additional provisions of the law for medical devices.

58. "active implantable medical device ' e medical device within the meaning of § 1, item 1 of the additional provisions of the law for medical devices.

59. "industrial monitoring and control instruments" are monitoring and control instruments that are designed exclusively for industrial or professional use.

60. "the presence of substitute" is the ability of a substitute can be manufactured and delivered within a reasonable period of time compared to the time required for the production and supply of substances determined by the Ordinance under art. 21 (e), para. 1.

61. "the reliability of the surrogate" is probability EEE using the surrogate, to perform the required function smoothly under certain conditions and for a specified period of time.


62. Spare part for Eee "is a separate part of the EEE, which can replace a part of this equipment and without which it cannot function as intended. The functionality of EEE is restored or improved when the part is replaced with a replacement part.

63. "mobile devices that are not intended for use on the road and are exclusively for professional use" are machines with on-board energy source whose functioning requires movement or continuous/intermittent shifting between several fixed jobs and are exclusively for professional use.

64. "the interests of the Republic of Bulgaria, national security" are as defined in § 1, item 16 of the additional provisions of the law on the protection of classified information. "

3. § 1a shall be inserted:

"§ 1 (a). This law introduces the requirements of Directive 2011/65/EC of the European Parliament and of the Council of 8 June 2011 on the restriction of use of certain hazardous substances in electrical and electronic equipment (OJ L 174/88, as from 1 July 2011). "

Transitional and final provisions

§ 10. The law on technical requirements for products (promulgated, SG. 86 of 1999; amend., SG. 63 and 93 since 2002, no. 18, and 107 since 2003, issue 45, 77, 88, 95 and 105 by 2005, issue 30, 62 and 76 in 2006, and 41/86 of 2007 74/2009 No. 80 by 2010. , PC. 38 by 2011, issue. 38, 53 and 77 by 2012.) make the following additions:

1. In art. 27, al. 1, after the words "implementing measures under art. 26 and "insert" by that Act and/or requirements of Chapter five "a" and of the Ordinance under art. 21 (e), para. 1 of the law on protection from the harmful effects of chemical substances and mixtures.

2. In art. 28, para. 1, after the words "implementing measures under art. 26 and "insert" by that Act and/or the Ordinance under art. 21 (e), para. 1 of the law on protection from the harmful effects of chemical substances and mixtures.

3. In art. 30, para. 2, after the words "the Ordinances under art. 7 "insert" by that Act and/or the Ordinance under art. 21 (e), para. 1 of the law on protection from the harmful effects of chemical substances and mixtures.

4. In art. 30 (a), para. 1, 2, 3 and 4 all over the place after the words "ecodesign requirements" and "shall be added and/or requirements of the Ordinance under art. 21 (e), para. 1 of the law on protection from the harmful effects of chemical substances and mixtures.

5. In art. 30 (b), para. 2, after the words "implementing measures under art. 26 and "insert" by that Act and/or the Ordinance under art. 21 (e), para. 1 of the law on protection from the harmful effects of chemical substances and mixtures.

6. In art. 30 in, al. 1, after the words "the Ordinances under art. 7 "insert" by that Act and/or the Ordinance under art. 21 (e), para. 1 of the law on protection from the harmful effects of chemical substances and mixtures.

7. In art. 30 g, para. 1, paragraph 2, after the words "implementing measures under art. 26 and "insert" by that Act and/or the Ordinance under art. 21 (e), para. 1 of the law on protection from the harmful effects of chemical substances and mixtures.

§ 11. In the medical devices Act (promulgated, SG. 46 2007; amend., 110/2008, no. 41 and 82 from 2009, no. 98 of 2010 No. 39 and 60 by 2011 and 54/2012) make the following additions:

1. In art. 4 create al. 3 and 4:

"(3) where the medical device under art. 2, al. 1, paragraphs 1 and 3, falls within the scope of chapter v of the law on protection from the harmful effects of chemical substances and mixtures, it is applied and the requirements for restricting the use of hazardous substances, as defined by the Ordinance under art. 21 (e), para. 1 of the same law.

(4) the requirements of paragraphs 1 and 2. 3 apply for cable or spare parts for the repair, re-use, for updating of characteristics or to increase the capacity of the device. "

2. In art. 11, para. 1 and 3, after the words "the Ordinances under art. 18 "" is added by this Act and/or the chapter five "a" and of the Ordinance under art. 21 (e), para. 1 of the law on protection from the harmful effects of chemical substances and mixtures.

3. In art. 13, para. 1, after the words "the Ordinances under art. 18 "" is added by this Act and/or the chapter five "a" and of the Ordinance under art. 21 (e), para. 1 of the law on protection from the harmful effects of chemical substances and mixtures.

4. In art. 14, para. 1, after the words "relevant regulations under art. 18 "insert" by that Act and/or the Ordinance under art. 21 (e), para. 1 of the law on protection from the harmful effects of chemical substances and mixtures.

5. In art. 15, para. 9, after the words "shall be added to the" products "and/or the chapter five" a "and of the Ordinance under art. 21 (e), para. 1 of the law on protection from the harmful effects of chemical substances and mixtures.

6. In art. 86, para. 1 and art. 93, para. 1, after the words "the Ordinances under art. 18 "" is added by this Act and/or the chapter five "a" and of the Ordinance under art. 21 (e), para. 1 of the law on protection from the harmful effects of chemical substances and mixtures.

§ 12. The provision of art. 21, para. 1 shall not apply to:

1. medical devices placed on the market before July 22, 2014;

2. monitoring and control instruments placed on the market before July 22, 2014;

3. in vitro diagnostic medical devices placed on the market before July 22, 2016;

4. industrial monitoring and control instruments placed on the market before July 22, 2017;

5. cables or spare parts for repair, reuse, updating of the functional specifications or enhancing the capacity of: a) electrical and electronic equipment put on the market before 1 July 2006;

(b)) medical devices placed on the market before July 22, 2014;

c) monitoring and control instruments placed on the market before July 22, 2014;

d) in vitro diagnostic medical devices placed on the market before July 22, 2016;

e) industrial monitoring and control instruments placed on the market before July 22, 2017;


f) electrical and electronic equipment, which is used the right of exemption and who has been placed on the market before the end of the period of the exemption, in so far as it relates to the exemption;

6. spare parts reused, recovered from EEE placed on the market before 1 July 2006 and used in the equipment placed on the market before 1 July 2016, provided that reuse is carried out in a controlled closed return system between economic operators and the user is notified of this reuse of parts.

§ 13. Electrical and electronic equipment that does not fall within the scope of applications Nos 1 and 2 to the Ordinance on the requirements for the placing on the market of electrical and electronic equipment and the management of waste electrical and electronic equipment (promulgated, SG. 36 of 2006; amend., 57/2006, no. 53 from 2008, issue 5/2009 and no. 29 of 2011.) but does not meet the requirements of Chapter five "a" and the Ordinance under art. 21 (e), para. 1, may continue to be marketed until 22 July 2019, if it is in accordance with § 12, item 1 – 5.

§ 14. The Council of Ministers shall adopt Ordinance referred to in art. 21 (e), para. 1 within three months from publication of this law in the Official Gazette.

§ 15. The law goes into effect from 2 January 2013.

The law was adopted by 41-Otto National Assembly on 18 October 2012 and is stamped with the official seal of the National Assembly.

President of the National Assembly Tsetska Tsacheva:

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