On Implementation of the Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 Concerning the Making Available on the Market and Use of Biocidal Products


Published: 0000-00-00

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Consolidated version as of 01/04/2016
 
 
 
GOVERNMENT OF THE REPUBLIC OF LITHUANIA
 
 
 
RESOLUTION No 686
 
ON
 
IMPLEMENTATION OF THE REGULATION (EU) No 528/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 May 2012 concerning the making available on the market and use of biocidal products
 
 
 
24 July 2013
 
Vilnius
 
 
 
For the implementation of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ 2012 L 167/1) (hereinafter referred to as ‘Regulation (EU) No 528/2012’), the Government of the Republic of Lithuania has  resolved:
 
1. to appoint:
 
1.1. the Ministry of Health as the competent authority coordinating the implementation of Regulation (EU) No 528/2012;
 
1.2. the National Public Health Centre under the Ministry of Health (hereinafter referred to as the ‘National Public Health Centre’) as the competent authority of the Republic of Lithuania to implement the tasks assigned to the national competent authorities under Regulation (EU) No 528/2012.
 
2. To ensure that the concepts used in this Resolution are defined in Regulation (EU) No 528/2012.
 
3. Confer on:
 
3.1. the Ministry of Health or its authorised body:
 
3.1.1. to coordinate the drafting of national legislation required for the implementation of Regulation (EU) No 528/2012;
 
3.1.2. to provide notifications to the Commission laid down in Regulation (EU) No 528/2012 on the national legislation for the implementation of Regulation (EU) No 528/2012;
 
3.2. the Ministry of National Defence, in agreement with the Ministry of Health, shall approve the legislation on exemptions from the requirements of Regulation (EU) No 528/2012 for certain biocidal products used for the defence purposes;
 
3.3. the Ministry of Health or its authorised body, in collaboration with the State Food and Veterinary Service, shall draft legislation on state taxes for services laid down in points 3.4.10 and 3.5 of this Resolution in accordance with Article 80 of Regulation (EU) No 528/2012;
 
3.4. the National Public Health Centre:
 
3.4.1. to participate in the meetings of the Biocidal Products Committee, the coordination group, the Standing Committee on Biocidal Products, and working groups established in the European Chemicals Agency, and to ensure that the employees of the National Public Health Centre that are the members of the Biocidal Products Committee are provided with scientific and technical assistance required for their work in the Committee;
 
3.4.2. to exercise the functions of national helpdesk, in collaboration with the State Food and Veterinary Service, that should consult the applicants, the manufacturers of the biocidal products, the importers, the downstream users, and other interested parties on the matters related to their relevant responsibilities, obligations and rights laid down in Regulation (EU) No 528/2012;
 
3.4.3. to present reports to the Commission on the implementation of Regulation (EU) No 528/2012 in Lithuania;
 
3.4.4. to submit proposals for the Commission to enter or remove active substances to the Annex I of Regulation (EU) No 528/2012, as well as restrict entries of active substances;
 
3.4.5. to submit proposals for the Commission to exempt the biocidal products from the European Union authorisation in Lithuania (hereinafter referred to as ‘the Union’) or adapt conditions of the authorisation of the Union to Lithuania;
 
3.4.6. to send explanations concerning the conditions for granting an authorisation for biocidal products that do not comply with the requirements of Regulation (EU) No 528/2012 to the competent authorities of the reference Member States, applicants and authorisation holders, and receive relevant explanations from them;
 
3.4.7. to provide the public with the information about the benefits and risks associated with biocidal products and ways of minimising their use;
 
3.4.8. to receive notifications from authorisation holders concerning the making available on the market of biocidal products authorised in accordance with the simplified authorisation procedure; if the biocidal products authorised in accordance with the simplified authorisation procedure do not comply with the requirements of Regulation (EU) No 528/2012, it should refer that matter to the coordination group;
 
3.4.9. to ensure the installation and functioning of hardware and software required for the implementation of the requirements of Regulation (EU) No 528/2012, the functioning of the Register for Biocidal Products, and the protection of confidential information concerning the biocidal products provided by applicants;
 
3.4.10. to authorise biocidal products, as well as authorise biocidal products in accordance with the simplified authorisation procedure and the mutual recognition; to renew the authorisation, to modify and cancel the authorisation, to perform a comparative assessment of biocidal products; to grant a parallel trade permit for a biocidal product that is authorised in another Member State (‘parallel trade permit’); in accordance with the provision on derogations from the requirements, for a period not exceeding 180 days, to permit the making available on the market or limited use of biocidal products which do not fulfil the conditions of authorisation laid down in Regulation (EU) No 528/2012; until a new active substance is approved, to provisionally authorise, for a period not exceeding three years, a biocidal product containing that new active substance; to adjust the terms and conditions of the authorisation or refuse to grant an authorisation under the mutual recognition procedure, in accordance with the criteria set out in Regulation (EU) No 528/2012, with the exception of product-types and uses assigned to the State Food and Veterinary Service laid down in point 3.5 of this Resolution; to make decisions on the authorisation or prohibition of use of an unauthorized biocidal product or a non-approved active substance exclusively for the use in experiments or tests in a biocidal product for the purposes of research or development;
 
3.4.11. to record and communicate the decisions in relation to the authorisations of biocidal products (authorisation, refusal to grant an authorisation, modification of the authorisation, renewal of the authorisation, cancellation of the authorisation, grant a parallel trade permit, refuse to grant a parallel trade permit, cancel a parallel trade permit) in the Register for Biocidal Products, as well as update that recorded and communicated information according to the relevant amendments;
 
3.5. for the State Food and Veterinary Service to authorize biocidal products within its respective competence in accordance with the simplified authorisation procedure and the mutual recognition; to renew the authorisation, to modify and cancel the authorisation; to perform a comparative assessment of biocidal products; to grant a parallel trade permit; in accordance with the provision on derogations from the requirements, for a period not exceeding 180 days, to permit the making available on the market or limited use of biocidal products which do not fulfil the conditions of authorisation laid down in Regulation (EU) No 528/2012; until a new active substance is approved, to provisionally authorise, for a period not exceeding three years a biocidal product containing that new active substance; to adjust the terms and conditions of the authorisation or refuse to grant an authorisation under the mutual recognition procedure, in accordance with the criteria set out in Regulation (EU) No 528/2012: for all biocidal products of product-type 3 (veterinary hygiene), the biocidal products of product-type 4 (food and feed area) used only for feed or drinking water for animals, the biocidal products of product-type 14 (rodenticides) used for the places of production, housing and transportation of animals, the biocidal products of product-type 18 (insecticides, acaricides and products to control other arthropods) used only for the purposes of veterinary hygiene, and applied directly on the skin or in the places of animal production, housing and transportation; the biocidal products of product-type 19 (repellents and attractants) used only for the places of rearing, housing and transportation of animals, and the biocidal products of product-type 22 (embalming and taxidermist fluids) used for the disinfection and preservation of animal corpses, or parts thereof;
 
3.6. for the State Consumer Rights Protection Authority:
 
3.6.1. within the area of supervision of its respective competence to supervise whether:
 
3.6.1.1. biocidal products available on the market are validated in accordance with points 3.4.10 and 3.5 of this Resolution;
 
3.6.1.2. biocidal products placed on the market are classified, packed and labelled in accordance to the requirements of Regulation (EU) No 528/2012
 
3.6.1.3. the active substances in treated articles available on the market are entered in Annex I of Regulation (EU) No 528/2012 or the list of active substances approved by the European Union, and whether the requirements of use of active substances in treated articles are followed in accordance with the relevant annex or list;
 
3.6.1.4. the treated articles available on the market are labelled in accordance with the requirements of Regulation (EU) No 528/2012;
 
3.6.1.5. authorisation holders of the biocidal products keep records of the biocidal products they make available on the market;
 
3.6.1.6. manufacturers of the biocidal products maintain, in relation to the manufacturing process, appropriate documentation in paper or electronic format relevant for the quality and safety of the biocidal products they make available on the market and store production batch samples;
 
3.6.2. to perform supervision of the requirements of the advertisement of biocidal products laid down in Regulation (EU) No 528/2012;
 
3.7. for the Customs Department of the Republic of Lithuania within the area of supervision of its respective competence to supervise whether biocidal products imported from third countries are validated in accordance with points 3.4.10 and 3.5 of this Resolution;
 
3.8. for the State labour inspectorate under the Ministry of Social Security and Labour within the area of supervision of its respective competence to supervise whether the biocidal products are used in accordance with the special requirements of the protection of the health and safety of workers set out in the authorisations or permits laid down in points 3.4.10 and 3.5 of this Resolution;
 
3.9. Expired from 01/04/2016
 
3.10. for the State Food and Veterinary Service, and the National Public Health Centre within the area of supervision of their respective competence to supervise whether:
 
3.10.1. the biocidal products are validated in accordance with points 3.4.10 and 3.5 of this Resolution;
 
3.10.2. the biocidal products are used in accordance with the requirements of the authorisations or permits laid down in points 3.4.10 and 3.5 of this Resolution;
 
3.10.3. manufacturers of biocidal products maintain, in relation to the manufacturing process, appropriate documentation in paper or electronic format relevant for the quality and safety of the biocidal product they make available on the market and store production batch samples;
 
4. Confer on the National Public Health Centre:
 
4.1. on the basis of proposal of the State Food and Veterinary Service, the State Consumer Rights Protection Authority, and the Environmental Protection Agency to apply provisional measures for the biocidal products pursuant to the safeguard clause without prejudice to the requirements of Article 17 of the Law on Chemical Substances and Preparations of the Republic of Lithuania;
 
4.2. provisionally restrict or prohibit making available on the market or use of the biocidal products in Lithuania which do not comply with the requirements of Regulation (EU) No 528/2012 which have been authorized in other Member State in accordance with the simplified authorisation procedure;
 
4.3. notify the Commission and the competent authorities of other Member States of information received from the authorisation holder concerning unexpected or adverse effects of the authorised biocidal product;
 
4.4. notify the Commission and the competent authorities of other Member States of provisional measures taken in Lithuania in accordance with the safeguard clause;
 
4.5. notify the Commission and the competent authorities of other Member States of information on the decisions taken concerning permission or prohibition of use of an unauthorised biocidal product or a non-approved active substance exclusively for the use in experiments or tests in a biocidal product for the purposes of research and development.
 
5. Expired from 17/12/2015.
 
 
 
Prime Minister                                                                                              Algirdas Butkevičius
 
 
 
Minister of Health                                                                            Vytenis Povilas Andriukaitis
 
 
 
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