ORDINANCE ON THE CONDITIONS AND PROCEDURES FOR THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET

Transcription

1 ORDINANCE ON THE CONDITIONS AND PROCEDURES FOR THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET In force since Adopted by Decree of the Council of Ministers No. 336 of Promulgated in SG, issue 4 of 15 th January 2008, amended in SG, issue 51 of 3 rd June Article 1. (1) This Ordinance lays down the conditions and procedures for the placing of biocidal products on the market. (2) This Ordinance shall lay down also the following: 1. the form and contents of the technical dossier and the documents to be presented by the applicant for the following: a) issue of an authorization for the placing of a biocidal product on the market; b) issue of a certificate of registration of a low-risk biocidal product; c) entry of an active substance on the lists under Article 14, para 4, items 1, 2, and 3 of the Law on protection from the harmful impact of the chemical substances and preparations (LPHICSP); 2. form and contents of the issued authorizations and certificates of registration; 3. further requirements to the packaging and labelling of biocidal products; 4. biocidal product types (groups and sub-groups); 5. common principles for the evaluation of technical dossiers for biocidal products; 6. content of the registers of approved biocidal products and registered low-risk biocidal products. Article 2. Biocidal products shall be placed on the market and used under the following conditions: 1. when an authorization or a certificate of registration is available for them pursuant to the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations; 2. when they do not fall within the ban or restrictions for marketing or use pursuant to the Ordinance on the hazardous chemical substances and preparations subject to ban or

2 restrictions of marketing and use, adopted by Decree No. 130 of the Council of Ministers of 2002 (promulgated in the SG, issue 69 of 2002; amended in issue 62 of 2004, issue 97 of 2005, issue 5 of 2007; amended in issue 9 of 2007; amended in issue 52 of 2007). Article 3. (1) A biocidal product classified according to Chapter 2 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations as toxic, very toxic or as a category 1 or 2 carcinogen, or as a category 1 or 2 mutagen or toxic for reproduction category 1 or 2, shall not be authorised for marketing to, or use by the general public. (2) When the assessment of the data presented for the biocidal products reveals danger for the health and safety of humans, animals, or the environment, biocidal products classified in hazard categories other than the ones specified in Article 1 shall not be authorized for marketing to or use by the general public. Article 4. (1) The name of the active substance in biocidal products shall be indicated pursuant to Annex No. 1 to the Ordinance on the procedures and manner of classification, packaging, and labeling chemical substances and preparations, adopted by Decree No. 316 of the Council of Ministers of 2002 (promulgated in the SG, issue 5 of 2003; amended in issue 66 of 2004, issue 50 and 57 of 2005, and issue 20 of 2007), and in the event that the active substance is not on the list in Annex No.1, its name shall be indicated pursuant to Annex No. 4 to the Ordinance on the procedures and manner of classification, packaging, and labeling chemical substances and preparations. (2) In the event that the active substance is not on the list in the Annexes pursuant to para 1, its name shall be determined pursuant to ISO or IUPAC. Article 5. (1) The applicant shall submit to the Ministry of Health the documents pursuant to Article 17, para 2, 3, and 4 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations for the issue of an authorization for the placing on the market of a biocidal product with at least one active substance entered on the lists under Article 14, para 4, item 1 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations. (2) A technical dossier pursuant to Article 17, para 3, item 2 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations shall be drawn up pursuant to Annex No.1 for a biocidal product with an active substance which is a chemical substance. (3) With a view to the type, properties, mode of action and field of use envisaged of the biocidal product, in addition to the data under Article 2, further data shall be submitted under Annex No. 2. (4) A technical dossier pursuant to Article 17, para 3, item 2 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations shall be drawn up

3 pursuant to Annex No. 3 for a biocidal product with an active substance which is a microorganism, including viruses or fungi. (5) A technical dossier pursuant to Article 17, para 3, item 3 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations shall be drawn up pursuant to Annex No. 4 for an active substance which is a chemical substance. (6) With a view to the type, properties, mode of action and field of use envisaged of the active substance, in addition to the data under Article 5, further data shall be submitted under Annex No. 5. (7) A technical dossier pursuant to Article 17, para 3, item 3 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations shall be drawn up pursuant to Annex No. 6 for an active substance which is a micro-organism, including viruses or fungi. Article 6. (1) The applicant shall submit to the Ministry of Health the documents pursuant to Article 17e, para 2, 3, and 4 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations for the issue of a certificate of registration for a low-risk biocidal product with an active substance entered on the lists under Article 14, para 4, item 2 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations. (2) A technical dossier pursuant to Article 17e, para 3, item of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations shall be drawn up pursuant to Annex No. 4 for an active substance which is a chemical substance. (3) With a view to the type, properties, mode of action and field of use envisaged of the active substance, in addition to the data under Article 2, further data shall be submitted under Annex No. 5. (4) A technical dossier pursuant to Article 17e, para 3, item 2 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations shall be drawn up pursuant to Annex No. 6 for an active substance which is a micro-organism, including viruses or fungi. (5) The data under Article 17e, para 3, item 3, letters "а" - "l" of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations shall be prepared in the form of a technical dossier pursuant to Annex No 7. Article 7. (1) The applicant shall submit to the Ministry of Health the documents pursuant to Article 17k, para 4 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations for renewal of the authorization of the marketing a biocidal product under Article 17b of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations.

4 (2) The documents under Article 17k, para 4, item 2 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations shall include the following: 1. a dossier on the active substance: a) for active substance which is a chemical substance, a technical dossier shall be presented pursuant to Annex No.4 and if necessary, in view of the type, properties, mode of action and envisaged field of use of the active substance, further data shall be presented pursuant to Annex No. 5. b) a technical dossier pursuant to Annex No. 6 shall be presented for an active substance which is a micro-organism, including viruses or fungi; 2. a dossier on the the biocidal product: a) for a biocidal product with an active substance which is a chemical substance, a technical dossier shall be presented pursuant to Annex No. 1 and if necessary, in view of the type, properties, mode of action and envisaged field of use of the active substance, further data shall be presented pursuant to Annex No. 2; b) a technical dossier pursuant to Annex No. 3 shall be presented for a biocidal product with an active substance which is a micro-organism, including viruses or fungi; (3) (Amended - SG, issue 51 of 2008, in force since ) The presentation of data pursuant to Article 2, item 1, with the exception of data pursuant to items 1.2 and 2 of Annex No. 4 and pursuant to section I. Identity of the micro-organism in Annex No. 6 shall be optional when they are available and have not been modified. (4) The Minister of Health shall have the right to require samples of the biocidal product and its components for a check of compliance with the following: 1. conditions pursuant to Article 16, para 1 and 2 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations; 2. data under Article 2, items 1 and 2. Article 8. (1) The applicant shall submit to the Ministry of Health the documents pursuant to Article 17k, para 4 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations for the renewal of the certificate of registration of a low-risk biocidal product pursuant to Article 17e, para 12 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations. (2) The documents under Article 17k, para 4, item 2 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations shall include the following:

5 1. a dossier on the active substance: a) for an active substance which is a chemical substance, a technical dossier shall be presented pursuant to Annex No.4 and if necessary, in view of the type, properties, mode of action and envisaged field of use of the active substance, further data shall be presented pursuant to Annex No. 5. b) a technical dossier pursuant to Annex No. 6 shall be presented for an active substance which is a micro-organism, including viruses or fungi; 2. a dossier of the biocidal product pursuant to Annex No. 7. (3) (Amended - SG, issue 51 of 2008, in force since ) The presentation of data pursuant to Article 2, item 1, with the exception of data pursuant to items 1.2 and 2 of Annex No. 4 and pursuant to section I. Identity of the micro-organism in Annex No. 6 shall be optional when they are available and have not been modified. (4) The Minister of Health shall have the right to require samples of the biocidal product, respectively the low-risk biocidal product and its compositions for a check of compliance with the following: 1. conditions pursuant to Article 16, para 1 and 2 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations; 2. data under Article 2, items 1 and 2. Article 9. (1) The applicant shall submit to the Ministry of Health the documents pursuant to Article 17о, para 2 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations for the issue of an authorization for the marketing of a biocidal product based on the established frame-formulation. (2) The documents pursuant to Article 17о, para 2, item 2 shall be prepared pursuant to Article 5, para ) Certain information under Article 5, para 2-7 shall be optional for presentation when the applicant presents an acceptable justification in writing referring to the existing frame-formulation he is the owner of or when the applicant is a holder of a declaration for the use of information. Article 10. (1) The applicant shall submit to the Ministry of Health the documents pursuant to Article 17о, para 3 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations for the issue of a certificate of registration for the marketing of a low-risk biocidal product based on the established frame-formulation. (2) The documents pursuant to Article 17о, para 3, item 2 shall be prepared pursuant to Article 6, para 2-5.

6 3) Certain information under Article 6, para 2-5 shall be optional for presentation when the applicant presents an acceptable justification in writing referring to the existing frame-formulation he is the owner of or when the applicant is a holder of a declaration for the use of information. Article 11. (1) The applicant shall submit to the Ministry of Health the documents pursuant to Article 18, para 1 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations for the entry of the active substance on the lists pursuant to Article 14, para 4, item 1, 2 or 3 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations. (2) A technical dossier pursuant to Article 18, para 1, item 3 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations shall be drawn up pursuant to Annex No. 4 for an active substance which is a chemical substance. (3) With a view to the type, properties, mode of action and field of use envisaged of the active substance, in addition to the data under Article 2, further data shall be submitted under Annex No. 5. (4) A technical dossier pursuant to Article 18, para 1, item 3 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations shall be drawn up pursuant to Annex No. 6 for an active substance which is a micro-organism, including viruses or fungi. (5) A technical dossier pursuant to Article 18, para 1, item 4 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations shall be drawn up pursuant to Annex No.1 for a biocidal product with an active substance which is a chemical substance. (6) With a view to the type, properties, mode of action and field of use envisaged of the biocidal product, in addition to the data under Article 5, further data shall be submitted under Annex No. 2. (7) A technical dossier pursuant to Article 18, para 1, item 4 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations shall be drawn up pursuant to Annex No. 3 for a biocidal product with an active substance which is a microorganism, including viruses or fungi. Article 12. The documents specified in Article 11 shall be submitted for the issue of a temporary authorization for the placing on the market of a biocidal product or of a certificate of registration for a low-risk biocidal product pursuant to Article 18c of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations. Article 13. (1) For the issue of a new authorization under Article 18c, para 8 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations, the

7 applicant shall submit to the Ministry of Health an application and the following documents: 1. a) for a biocidal product with an active substance which is a chemical substance, a dossier shall be presented pursuant to Annex No. 1 and if necessary, in view of the type, properties, mode of action and envisaged field of use of the biocidal product, further data shall be presented pursuant to Annex No. 2; 2. b) a technical dossier pursuant to Annex No. 3 shall be presented for a biocidal product with an active substance which is a micro-organism, including viruses or fungi; 3. a) for an active substance which is a chemical substance, a technical dossier shall be presented pursuant to Annex No.4 and if necessary, in view of the type, properties, mode of action and envisaged field of use of the active substance, further data shall be presented pursuant to Annex No b) a technical dossier pursuant to Annex No. 6 shall be presented for a biocidal product with an active substance which is a micro-organism, including viruses or fungi; (2) For the issue of a new certificate of registration for a low-risk biocidal product under Article 18c, para 8 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations, the applicant shall submit to the Ministry of Health an application and the following documents: 1. a dossier of the low-risk biocidal product pursuant to Annex No. 7; 2. a) for an active substance which is a chemical substance, a dossier shall be presented pursuant to Annex No.4 and if necessary, in view of the type, properties, mode of action and envisaged field of use of the active substance, further data shall be presented pursuant to Annex No. 5; 3. b) a technical dossier pursuant to Annex No. 6 shall be presented for a biocidal product with an active substance which is a micro-organism, including viruses or fungi; (3) (Amended - SG, issue 51 of 2008, in force since ) The presentation of data pursuant to Article 1, items 3 and 4, and para 2, items 2 and 3, with the exception of data pursuant to items 1.2 and 2 of Annex No. 4 and pursuant to section I. Identity of the micro-organism in Annex No. 6 shall be optional when they are available and have not been modified. Article 14. (1) The applicant shall submit to the Ministry of Health the documents pursuant to Article 19d, para 2 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations for the issue of an authorization for a biocidal product, authorized in an EU Member State by mutual recognition of the authorization.

8 a) for a biocidal product with an active substance which is a chemical substance, the data shall be presented pursuant to Annex No.1, item 10 and if necessary, in view of the type, properties, mode of action and envisaged field of use of the biocidal product, further data shall be presented pursuant to Annex No. 2, item 4. b) the data pursuant to Annex No. 3, Section ХII. shall be presented for a biocidal product with an active substance which is a micro-organism, including viruses or fungi; Article 15. (1) The applicant shall submit to the Ministry of Health the documents pursuant Article 19g, para 2 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations for the issue of a certificate of registration for a low-risk biocidal product, authorized in an EU Member State by mutual recognition of the registration. (2) For a low-risk biocidal product, the data pursuant to Annex No. 7 shall be submitted, with the exception of the effectiveness data under item 4 which shall be presented in a summary. Article 16. (1) For the issue of an authorization for the placing on the market of a biocidal product with an existing active substance(s) and biocidal product-types specified in Annex No. 2 of Regulation (EC) No. 2032/2003 of the Commission of 4 November 2003 concerning the second phase of the 10-year work programme referred to in Article 16 (2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market and amending Regulation (EC) No. 1896/2000 (OJ, Special Edition of 2007, Chapter 03, Volume 51), the applicant shall submit to the Ministry of Health the documents under Article 19r of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations. (2) The technical dossier under Article 19r, para 2, item 2 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations shall be prepared in compliance with Annex No. 8. (3) The Ministry of Health shall keep the documentation related to the issue, modification, or cancelling of the authorizations for the placing of biocidal products on the market. Article 17. (1) The evaluation of the technical dossiers under Articles 5-15 shall be carried out in compliance with Annex No. 9 (2) The technical dossiers shall contain a detailed and complete description of the tests carried out and the methods applied or a bibliographical reference to these methods. (3) An evaluation of the effects and properties under Article 16, para 2 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations сshall be carried out based on the information in the technical dossiers.

9 (4) Certain information in the dossier requirements shall be optional for submission when: 1. it is not related to the biocidal product type and the envisaged field of use. 2. this is technically impossible due to the nature of the biocidal product, its specific properties, and other technical reasons; 3. there are scientifically grounded reasons related to the biocidal product. (5) In cases under para 4 the applicant shall present a justification in writing referring to the existing frame-formulation when the applicant holds a declaration for access to the information. Article 18. The applicant shall submit the following documents to the Ministry of Health for the issue of an authorization for marketing a biocidal product pursuant to Article 30, para 5 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations: 1. Certificate of legal standing for entry in the Commercial Register or an equivalent registration in accordance with the law of a Member State of the EU or the law of another country - party to the Agreement for the European Economic Area; 2. data on the biocidal product, including: (a) the name and address of the biocidal product manufacturer; (b) name and address of the active substance manufacturer; c) trade name of the biocidal product; d) detailed quantitative and qualitative information on the composition of the biocidal product, e.g. active substance(s), impurities, adjutants, inert components, etc. e) chemical names of the compositions of the biocidal product, CAS and EU numbers (if available), classification data; f) summary of the physical and chemical, toxicological, and ecotoxicological data on the active substance and the biocidal product; g) analytical method for determining the concentration of the active substance(s) in the biocidal product; h) biocidal product type (subgroup), field of use and mode of use;

10 (i) efficacy data; k) category of users; l) data on classification, packaging, and labelling, including a label design; m) a safety data sheet pursuant to Article 7б of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations. Article 19. (1) (Amended - SG, issue 51 of 2008, in force since ) Tests for determining the physico-chemical, toxicological, and ecotoxicological properties of biocidal products shall be carried out in compliance with the methods laid down in Regulation of the Commission on testing methods, as specified in Article 13 (2) of Regulation (EC)No. 1907/2006. (2) When in the annex under para 1, no methods are specified, tests can be carried out in accordance with other internationally recognized methods. In such cases justified and complete information on the testing method applied shall be required. (3) Tests under Article 1 shall be carried out in compliance with the requirements of the Ordinance on the principles, inspection, and compliance with the Good Laboratory Practice, adopted by Decree No. 207 of the Council of Ministers of 2004 (SG, issue 74 of 2004), if appropriate, and in compliance with the requirements of Ordinance No. 15 of 2006 on the minimum requirements for protection and welfare of test animals and requirements on the facilities for their use, raising and/or supply (SG, issue 17 of 2006). (4) When the data from the tests for determining the physico-chemical, toxicological, and ecotoxicological properties of the biocidal products are obtained prior to 14 th February 1998 using methods other than the methods specified in para 1, the use of these data and the need of new tests applying the methods under para 1 shall be determined for each case. When judging whether to use the data or carry out new tests, the need of reducing tests on vertebrates shall be taken into consideration. Article 20. (1) The authorization for the placing of biocidal products on the market shall be issued in compliance with the sample in Annex No. 10. (2) The certificate of registration for the placing of low-risk biocidal products on the market shall be issued in compliance with the sample in Annex No. 11. Article 21. Biocidal products shall be classified, packaged, and labeled pursuant to the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations. Article 22. Biocidal products shall meet the following additional requirements:

11 1. the types, shape, and/or graphic design of the package of biocidal products shall be manufactured in a way so as to minimize the likelihood of being mistaken for food, drink or feedingstuff; 2. products available to the general public which may be mistaken for food, drink or feedingstuff shall contain components to discourage their consumption. Article 23. (1) The label of biocidal products shall be in Bulgarian. (2) The label of biocidal products shall contain the following supplementary information: 1. the identity of every active substance in the biocidal product and its concentration in metric units; 2. the authorisation number allocated to the biocidal product by the competent authority; 3. the biocidal product type (group and sub-group) the uses for which the biocidal product is authorized or registered; 4. the category of user; 5. the type of preparation, e.g. liquid concentrates, granules, powders; 6. directions for use and the dose rate, expressed in metric units, for each use provided for under the terms of the authorization or certificate of registration; 7. particulars of likely direct or indirect adverse side effects; 8. any first aid mesures and an antidote, if known; 9. directions for safe disposal of the biocidal product and its packaging, including, where relevant, any prohibition on reuse of packaging; 10. the formulation batch number or designation; 11. the date of production and the expiry date relevant to normal conditions of storage; 12. the period of time needed for the biocidal effect, the interval to be observed between: a) applications of the biocidal product, and/or b) application of the biocidal product and the next use of the productstreated, and/or c) the use of the biocidal product and access by man or animals to the area treated, including particulars concerning decontamination means and measures and duration of necessary ventilation of treated areas; particulars for adequate cleaning of equipment;

12 13. particulars concerning precautionary measures during use, storage and transport, including personal protective clothing and equipment, measures for protection against fire, covering of furniture, removal of food and feedingstuff and directions to prevent animals from being exposed; 14. information on any specific danger to the environment particularly concerning protection of non-target organisms and avoidance of contamination of water; 15. risk group and biological hazard indication, if necessary, pursuant to Ordinance No. 4 of 2002 on protection of workers from risks associated with exposure to biological agents at work (SG, issue 105 of 2002), when the active substance is a micro-organism. (3) (Amended - SG, issue 51 of 2008, in force since ) The biocidal product type pursuant to Article 2, item 3 shall be determined in accordance with Annex No. 12. (4) (Amended - SG, issue 51 of 2008, in force since ) The data pursuant to Article 2, т. 1-4 shall be always indicated on the label. Information under items 5 to 15 shall be indicated on the packaging or on an accompanying leaflet integral to the packaging and in such cases the labeling requirements shall be regarded as complied with. (5) When the biocidal product is place on the market with a leaflet, the sentence 'Read attached instructions before use` should be on the label. (6) No indications such as 'low-risk biocidal product`, 'non-toxic`, 'harmless` or similar indications presenting the biocidal product as safe or underestimating its dangerous properties, or exagerrating its properties and effects, should be placed on the label. Article 24. (1) Biocidal products placed on the market shall be used in accordance with the requirements of Article 16 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations, the requirements of the authorization issued, and the directions on the label. (2) The provisions of the regulations on occupational health and safety shall be met to protect workers during use of biocidal products at the workplace. Article 25. (1) The Minister of Health shall keep public registers on: 1. authorized biocidal products; 2. registered low-rik biocidal products. (2) The register under item 1 shall contain information on the following: 1. number and date of the authorization for the placing of the biocidal product on the market;

13 2. expiry date of the authorization issued, if any; 3. name and address of the person placing the biocidal product on the market; 4. name of the biocidal product; 5. name and concentration of the active substance(s) in the biocidal product; 6. type of the biocidal product in accordance with Annex No. 12 and field of use; 7. category of user; 8. date of cancellation of the authorization; 9. any modifications of the entered circumstances. (3) The register under item 2 shall contain information on the following: 1. number and date of the certificate of registration of a low-risk biocidal product; 2. expiry date of the certificate of registration issued, if any; 3. name and address of the person placing the low-risk biocidal product on the market; 4. name of the low-risk biocidal product; 5. name and concentration of the active substance(s) in the biocidal product and data on their classification; 6. type of the low-risk biocidal product in accordance with Annex No. 12 and field of use; 7. category of users; 8. date of cancellation of the registration; 9. any modifications of the entered circumstances. Additional Provisions 1. This Ordinance introduces the provisions of: 1. Directive 98/8/ЕC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ, Special edition 2007, Chapter 03, volume 24).

14 2. Commission Directive 2006/50/EC of 29 May 2006 amending Annexes IVA and IVB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ, Special edition 2007, Chapter 03, volume 72). Transitional and Final Provisions 2. The authorizations for the placing of biocidal products on the market, issued in accordance with the template in Annex No. 3 of Ordinance No. 44 on the conditions and procedures on the placing of biocidal products on the market (promulgated in the SG, issue 113 of 2004; amended in issue 48 of 2005) shall be in force, and Article. 19v of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations and 23 and 24 from the Transitional and Final Provisions on the Law amending the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations (SG, issue 82 of 2007). 3. This Ordinance is adopted on the grounds of Article 14а, Article 14b, para 2, and Article 14c, para 2 of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations. Transitional and Final Provisions TO DECREE NO. 114 OF 26 MAY 2008 AMENDING THE ORDINANCE ON THE PROCEDURES AND MANNER OF CLASSIFICATION, PACKAGING, AND LABELLING OF CHEMICAL SUBSTANCES AND PREPARATIONS, ADOPTED WITH DECREE NO. 316 OF THE COUNCIL OF MINISTERS OF 2002 (PROMULGATED IN - SG, issue 51 OF 2008, INFORCE SINCE ) 13. This Decree shall enter into force on June 1 st, 2008 with the exception of 11, items 1 and 3 of the Transitional and Final Provisions which shall enter into force on the day of its promulgation in the State Gazette. Annex No. 1 pursuant to Article. 5, para 2 Basic requirements to the dossier on an active substance which is a chemical substance. The dossier is required to contain at least all the points listed under Dossier requirements. Information in the sections shall be supported by the respective data. The dossier requirements must be in line with technical development. Where it is not scientifically necessary or technically possible to supply the information, as well as information which is not necessary owing to the nature of the biocidal product

15 or of its proposed uses, certain information need not be supplied. In such cases a justification in writing shall be presented by the applicant referring to the existing frameformulation provided that the applicant has a declaration for the right of use of this information. When the satisfactory justification is presented and in compliance with the requirements of the Ordinance, the data from the presented dossiers can be used. Whenever possible, the requirements to minimize animal testing shall be complied with pursuant to Ordinance No. 15 of 2006 on minimum requirements for protection and welfare of testing animals and requirements to the facilities for their use, raising and/or supply. Dossier requirements I. Contents 1. Data on the person placing biocidal products on the market and on the manufacturer of the biocidal product and the active substance. 2. Identity of the biocidal product. 3. Physical and chemical properties of the biocidal product 4. Methods for identification and analysis of the biocidal product 5. Intended uses and efficacy 6. Toxicological profile (in addition to the data on the active substance). 7. Ecotoxicological profile (in addition to the data on the active substance). 8. Measures necessary to protect humans, non-target organisms and the environment: 9. Classification, packaging and labelling of the biocidal product 10. Summary and evaluation of items 2 9. II. The sections specified in item I sections contain the following data: 1. Data on the person placing biocidal products on the market and on the manufacturer of the biocidal product and the active substance Name, address, and telephone of the person placing the biocidal product on the market Name and address of the manufacturer of the biocidal product and location of the plant.

16 1.3. Name and address of the manufacturer of the active substance and location of the plant. 2. Identity of the biocidal product Trade name or proposed trade name, and manufacturer's development code number of the preparation, if appropriate Detailed quantitative and qualitative information on the composition of the biocidal product, e.g. active substance(s), impurities, adjutants, inert components, etc Physical state and nature of the biocidal product, e.g. emulsifiable concentrate, wettable powder, solution. 3. Physical, chemical, and technical properties 3.1. Appearance (physical state, colour) 3.2. Explosive properties Oxidising properties 3.4. Flash-point and other indications of flammability or spontaneous ignition Acidity/alkalinity and if necessary ph value (1 % in water) 3.6. Relative density 3.7. Storage stability and shelf-life. Effects of light, temperature and humidity on technical characteristics of the biocidal product. Reactivity towards container material Technical characteristics of the biocidal product (e.g. wettability, persistent foaming, flowability, pourability and dustability) Physical and chemical compatibility with other products including other biocidal products with which its use is to be authorized. 4. Methods of identification and analysis Analytical method for determining the concentration of the active substance(s) in the biocidal product Analytical methods including recovery rates and the limits of determination for toxicologically and ecotoxicologically relevant components of the biocidal product and/or residues thereof, where relevant in or on the following:

17 (a) soil; (b) air; (c) water (including drinking water); (d) biological samples (fluids and tissues) from animal and human body; (e) treated food or feedingstuffs. Methods are presented which have not been indicated in relation to the requirements of Annex No. 4, item Intended uses and efficacy 5.1. Product type pursuant to Annex No. 12 and field of use envisaged Method of application including description of system used, when such system is envisaged Application rate and if appropriate, the final concentration of the biocidal product and active substance in the system in which the preparation is to be used (e.g. cooling water, surface water, water used for heating purposes) Number and timing of applications, and where relevant, any particular information relating to geographical variations, climatic variations, or necessary waiting periods to be observed between: a) the separate applications of the biocidal product, and/or b) the application of the biocidal product and the use of the treated products, and/or c) the use of the biocidal product and the access of humans or animals to treated areas Function: e.g. bactericide, fungicide, insecticide, rodenticide, etc Organism(s) to be controlled and products, organisms or objects to be protected Effects on target organisms Mode of action, including time delay, in so far as not covered by Annex 4, item User category: industrial, professional, general public. Efficacy data

18 5.10. The proposed label claims for the product and efficacy data to support these claims, including any available standard protocols used, laboratory tests, or field trials, where appropriate Any other known limitations on efficacy including resistance. 6. Toxicological studies Acute toxicity. For studies to 6.1.3, biocidal products other than gases shall be administered via at least two routes, one of which should be the oral route. The choice of the second route will depend on the nature of the product and the likely route of human exposure. Gases and volatile liquids should be administered by the inhalation route Oral Dermal Inhalation For biocidal products that are intended to be authorised for use with other biocidal products, the mixture of products, where possible, shall be tested for acute dermal toxicity and skin and eye irritation, as appropriate Skin and eye irritation. Eye-irritation test shall not be necessary where the biocidal product has been shown to have potential corrosive properties Skin sensitisation 6.4. Information on dermal absorption 6.5. Available toxicological data relating to toxicologically relevant non-active substances i.e. substances of concern 6.6. Information related to the exposure of the biocidal product to man and the operator. Where necessary, the test(s) described in Annex 5, shall be required for the toxicologically relevant non-active substances of the preparation. 7. Ecotoxicological studies Foreseeable routes of entry into the environment on the basis of the use envisaged Information on the ecotoxicology of the active substance in the product, where this cannot be extrapolated from the information on the active substance itself.

19 7.3. Available ecotoxicological information relating to ecotoxicological relevant nonactive substances (i.e. substances of concern), such as information from safety data sheets. 8. Measures to be adopted to protect man, animals and the environment 8.1. Recommended methods and precautions concerning handling, use, storage, transport or fire Specific treatment in case of an accident, e.g. first-aid measures, antidotes, medical treatment if available; emergency measures to protect the environment; in so far as not covered by Annex 4, paragraph Procedures, if any, for cleaning application equipment Identity of relevant gases and combustion products in cases of fire Procedures for waste management of the biocidal product and its packaging, e.g. possibility of reuse or recycling, neutralisation, conditions for controlled discharge, and incineration for different user categories Possibility of destruction or decontamination following release in or on the following: (a) air; (b) water (including drinking water); (c) soil Observations on undesirable or unintended side-effects, e.g. on beneficial and other non-target organisms Specify any repellents or poison control measures included in the preparation that are present to prevent adverse action against non-target organisms. 9. Classification, packaging and labeling Proposals for classification and labeling Proposals for safety-data sheets, where appropriate Justification for the classification and labelling according to Article 2, para 1, item 2 and Article 21: a) hazard category;

20 b) hazard symbol(s); c) risk phrases; d) safety phrases; e) packaging - materials, type, size, and graphic design, compatibility of the preparation with proposed packaging materials to be included, volume/capacity. 10. Summary and evaluation of items 2 9. Annex No.2 pursuant to Article. 5, para 3 Additional data set for biocidal products with and active substance which is a chemical substance The dossier addresses at least all the points listed under 'Dossier requirements` under Annex No. 1. Information in the sections is required to be supported by data. The dossier requirements must be in line with technical development. Where it is not scientifically necessary or technically possible to supply the information, as well as information which is not necessary owing to the nature of the biocidal product or of its proposed uses, certain information need not be supplied. In such cases a justification in writing shall be presented by the applicant referring to the existing frameformulation provided that the applicant has a declaration for the right of use of this information. When the satisfactory justification is presented and in compliance with the requirements of the Ordinance, the data from the presented dossiers can be used. Whenever possible, the requirements to minimize animal testing shall be complied with pursuant to Ordinance No. 15 of 2006 on minimum requirements for protection and welfare of testing animals and requirements to the facilities for their use, raising and/or supply. I. Further human health-related studies. 1. Food and feedingstuffs studies 1.1. If residues of the biocidal product remain on feedingstuffs for a significant period of time, then toxicokinetic studies and feeding studies in livestock shall be required to permit evaluation oflevels of residues in food of animal origin Effects of industrial processing and/or domestic preparation on the nature and magnitude of residues of the biocidal product.

21 2. Other test(s) related to the exposure to humans shall be carried out if necessary. II. Further studies on behaviour of the biocidal product in the environment. 1. Where relevant all the information required in Annex No. 5, Section VII. 2. Testing for distribution and dissipation in the following: (a) soil; (b) water; (c) air. Test requirements 1 and 2 above are applicable only to ecotoxicologically relevant components of the biocidal product. III. Further ecotoxicological studies 1. Effects on birds 1.1. Acute oral toxicity - when an avian species was not selected in advance for study under Annex No. 1, item Effects on aquatic organisms 2.1. In case of application on, in, or near to surface waters: Particular studies with fish and other aquatic organisms Residue data in fish concerning the active substance and including toxicologically relevant metabolites The studies referred to in Annex No. 5, Section VIII, items 2.1, 2.2, 2.3 and 2.4 may be required for relevant components of the biocidal product If the biocidal product is to be sprayed near to surface waters then an overspray study may be required to assess risks to aquatic organisms under field conditions. 3. Effects on other non-target organisms Toxicity to terrestrial vertebrates other than birds Acute toxicity to bees 3.3. Effects on beneficial arthropods other than bees.

22 3.4. Effects on earthworms and other soil non-target macro-organisms, believed to be at risk Effects on soil non-target micro-organisms Effects on any other specific, non-target organisms (flora and fauna) believed to be at risk If the biocidal product is in the form of bait or granules, the following tests are required: Supervised trials to assess risks to non-target organisms under field conditions Studies on acceptance by ingestion of the biocidal product by any nontarget organisms thought to be at risk. 4. Summary and evaluation of items 1, 2, and 3. Annex No. 3 pursuant to Article. 5, para 4 Data set for biocidal products Micro-organisms, including viruses and fungi 1. For the purposes of this Annex, the term micro-organisms shall be understood as including also viruses and fungi. This Annex lays determines data which is required for the issue of an authorization for a biocidal product containing micro-organisms. For all micro-organisms subject to an application for the issue of an authorization, all available data related to relevant knowledge and information in literature must be provided. The information related to the identification and characterisation of all components of a biocidal product is particularly important and must be entered in sections I to IV and provides the basis for an assessment of potential impacts of biocidal products on human health and of environmental effects. 2. Where information is not necessary owing to the nature of the biocidal product Article 17, para 4 and 5 shall apply. 3. Information can be provided from existing data provided that an acceptable justification is presented to the competent authority. To minimize animal testing whenever possible, the provisions of the Ordinance on the procedures and manner of classification, packaging, and labeling of chemical substances and preparations shall apply (Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and

23 labelling of dangerous substances (OJ, Special Edition 2007, Chapter 13, Volume 1), as well as of Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ, Special Edition 2007, Chapter 13, Volume 28). 4. When tests are carried out, a detailed description (specification) of the material used and its impurities shall be presented in accordance with the provisions of Section II. Whenever necessary, the data from Annexes No. 1 and 2 shall be presented on all chemical compositions of the biocidal product which are toxicologically and/or ecotoxicologically relevant, particularly when these components are substances of concern within the meaning of 1, item 27 of the additional provisions of the Law on Protection from the Harmful Impact of the Chemical Substances and Preparations. 5. In this case data from Annex No. 6 can be extrapolated on a new preparation provided that all possible effects of the components and particularly their pathogenicity and infectivity are evaluated. Sections I. Identity of the biocidal product Dossier requirements II. Physical, chemical, and technical properties of the biocidal product III. Data on application IV. Further information on the biocidal product. V. Analytical methods VI. Efficacy data VII. Effects on human health VIII. Residues in or on the treated materials, foods and feedingstuffs. IX. Fate and behaviour in the environment. Effects on non-target organisms. XI. Classification, packaging and labelling of the biocidal product XII. X. Summary and evaluation of sections I to XI including conclusions of the risk assessment and recommendations.

24 The sections contain the following data: I. Identity of the biocidal product 1.1. Applicant Manufacturer of the biocidal product and the micro-organism(s) Trade name or proposed trade name, and manufacturer's development code number of the preparation Detailed quantitative and qualitative information on the composition of the biocidal product Physical state and nature of the biocidal product Function. II. Physical, chemical, and technical properties of the biocidal product 2.1. Appearance (colour and odour) 2.2. Storage stability - stability and shelf-life Effects of light, temperature and humidity on technical characteristics of the biocidal product Other factors having impact on stability Explosive and oxidizing properties Flash-point and other indications of flammability or spontaneous ignition Acidity/alkalinity and if necessary ph value Viscosity and surface tension Technical characteristics of the biocidal product Wettability Persistent foaming Suspensibility and suspension stability Wet sieve test and dry sieve test.

25 Particle size distribution (dust which can be turned into dust particles and wettable dust, granules), content of dust/fines (granules), attrition and friability (granules) Emulsifiability, re-emulsifiability, emulsion stability Flowability, pourability and dustability Physical and chemical compatibility with other products including biocidal products with which its use is to be authorized or registered Physical Chemical compatibility Biological compatibility Summary and evaluation of the physical, chemical, and technical properties of the biocidal products. III. Data on application 3.1. Field of use envisaged Mode of action Details of intended use Application rate Content of micro-organism in material used (e.g. in the application device or bait) Method of application Number and timing of applications and duration of protection Necessary waiting periods or other precautions to avoid adverse effects to human and animal health and the environment Proposed instructions for use Category of users Information on the possible occurrence of the development of resistance Effects on the materials or products treated with the biocidal product.