MINISTRY OF HEALTH

No ……………………..

MINISTRY OF THE ENVIRONMENT, WATER AND FORESTS No …………………….. NATIONAL SANITARY VETERINARY AND FOOD SAFETY AUTHORITY No …………………….. ORDER

amending and completing Order No 10/368/11/2010 of the Ministry of Health, the Ministry of Environment and Forests, the National Sanitary Veterinary and Food Safety Authority approving the authorisation procedure for biocidal products placed on the Romanian market

In view of the Approval Reference No. of the Directorate-General for Medical Care, Emergency Medicine and Public Health Programs of the Ministry of Health;

Considering the provisions of Article 17 of Government Decision No 617/2014 on establishing the institutional framework and measures for implementing 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, as subsequently amended and supplemented;

Pursuant to Article 7(4) of Government Decision No 144/2010 regarding the organisation and operation of the Ministry of Health, as subsequently amended and supplemented, Article 13(4) of Government Decision No 38/2015 regarding the organisation and operation of the Ministry of the Environment, Water and Forests, as subsequently amended and supplemented, and Article 4(3) of Government Decision No 1415/2009 regarding the organisation and operation of the National Sanitary Veterinary and Food Safety Authority and its subordinated facilities, as subsequently amended and supplemented;

The Minister of Health, the Minister of the Environment, Water and Forests and the President of the National Sanitary Veterinary and Food Safety Authority

Hereby issue the following

ORDER:

Article I. Order No 10/368/11/2010 of the Minister of Health, Minister of the Environment and Forests and President of the National Sanitary Veterinary and Food Safety Authority approving the authorisation procedure for biocidal products that are placed on the Romanian market, published in the Official Gazette of Romania, Part I, No 196 of 29 March 2010, as subsequently amended and supplemented, is hereby amended and supplemented as follows:

In article 2, subparagraph f) shall be amended to read as follows:

“f) applicant — legal person intending to place a biocidal product on the Romanian market.”

In Article 2, after subparagraph f), 7 new subparagraphs g)-l) are inserted, reading as follows:

“g) Distributor: legal entity making available on the Romanian market an authorised biocidal product

h) Administrative amendment — an amendment to an existing authorisation, consisting of changing the data set out in Chapters I, II and III of the model authorisation set out in Annex 2 to this Order, without any impact on the properties or efficacy of the biocidal product.

i) Industrial user: user involved in the manufacture, handling and/or packaging of products on industrial premises, or using biocidal products in industrial processes, such as wood preservatives in the wood industry or disinfectants in the food industry.

j) Professional user: employed and/or self-employed user who uses finished biocidal products outside industrial premises but in the course of activities for the exercise of the profession, being trained and qualified in the responsibilities of his occupation and having a certain experience and ability in the use of personal protection equipment.

k) Professionally trained user: professional user with additional training and certification in accordance with the provisions of Order No 1225/5031/2003 of the Minister of Health and of the Minister for Education, Research and Youth approving the Methodology for the organisation and certification of the professional training of staff regarding the uptake of the basic notions of hygiene, as amended.

l) Non-professional user or population: a citizen who, as a consumer, uses a biocidal product privately at work or at home, on the basis of instructions for use.”

3. In article 3, paragraphs 2 and 3 shall be modified and have the following content:

2. For each biocidal product, 2 copies of the application in paper form and 3 copies of the dossier in electronic format, on USB/CD/DVD shall be submitted to the National Institute of Public Health — Technical Secretariat of the National Commission for Biocides.

3. The Technical Secretariat of the National Commission for Biocidal Products shall forward a copy of the technical file to the National Environmental Protection Agency and a copy of the technical dossier of biocidal products classified in TP 3, TP4, TP5 product-types with indications for drinking water intended for animal consumption and TP20 to the Institute for the Control of Biological Products and Veterinary Drugs.”

4. In article 4(1)a), subparagraph a.4 shall be amended to read as follows:

“a.4. form of conditioning, e.g.: liquid concentrate, granules, aerosols, powder, spray, napkins, packaging and packaging capabilities of the biocidal product expressed in metric units. The maximum packing capacities of the biocidal product for ‘population’ as user shall be differentiated as follows:

for TP1 biocidal products, the maximum capacity is 1L and for TP2, TP3 and TP4 biocidal products, the maximum capacity is 10 L;

for biocidal products of the main group 3: Pest control products: maximum capacity is 1 L for biocidal products in the form of liquid/emulsifiable concentrate or 500 g for biocidal products in the form of granules, powders, solids.”

5. In article 4(1)a), subparagraph a.7 shall be amended to read as follows:

“a.7. User categories: industrials, professionals, trained professionals, population;”

6. In article 4(1)b) is amended to read as follows:

‘b) the declaration by the manufacturer of the biocidal product on the identity of the active substance(s) respectively: for chemicals, CAS, EC identification numbers and concentration in metric units; for micro-organisms, the common name of the organism, the taxonomic name and the strain, the reference number of the collection and culture where the culture is stored;”

7. In article 4(1)d), subparagraph d.1 is amended to read as follows:

“d.1. the identity of each active substance with CAS No or EC number and concentration in metric units;” ”

8. In article 4(1)g), subparagraphs g1 and g2 shall be amended to read as follows:

“g1) for biocidal products in main group 1: Disinfectants, TP 1 product types with application in sanitary units, TP2 with application in sanitary facilities, TP3 with application in veterinary hygiene and TP 4 with application in food and feed, standard EN 14885:2015, as subsequently amended and supplemented, shall apply in assessing the product and demonstrating their efficacy. Where laboratory methods for demonstrating efficacy for an intended use are not set out in EN 14885:2015 as subsequently amended and supplemented, the Transitional Evaluation Effectiveness Guidelines for 1-5 product types, disinfectants, as subsequently amended and supplemented, displayed on the website of the European Chemicals Agency (ECHA) shall apply. For TP 5 product-type with application in drinking water, the Transitional Evaluation Effectiveness Guidelines for 1-5 product types, disinfectants, as subsequently amended and supplemented, displayed on the website of the European Chemicals Agency (ECHA), shall apply;”

“g2) for biocidal products classified in main group 1: Disinfectants, TP 1 and TP 2 with application in sanitary facilities, TP3 and TP 4, accepted test reports will be carried out in a laboratory using a method accredited according to SR EN ISO/IEC 17025 'Compliance assessment. General requirements for accreditation bodies accrediting conformity assessment bodies’, or in a laboratory complying with the principles of good laboratory practice (GLP) laid down in Government Decision No 63/2002 approving the Principles of Good Laboratory Practice, as well as inspection and verification of compliance with them for testing on chemicals. The reports shall contain the results of the effectiveness testing for each of the activities declared on the label and in the technical file of the product;”

9. In article 4(1)g), subparagraph g3 is repealed

10. Article 4(1)g), subparagraph g4 is amended to read as follows:

“g4) for TP 5 biocidal products — Drinking water for animals, accepted test reports will be carried out in an accredited laboratory.”

11. In article 4(1)g), subparagraph g5 is repealed.

12. In article 4(1)g), subparagraph g6 shall be amended to read as follows:

“g6) the testing date in the effectiveness test reports set out in points g1 and g4 must be after the date of publication of standard EN 14885:2015.'

13. In Article 4 after subparagraph i), a new subparagraph j) is inserted, reading as follows:

“j) Proof of payment of the fee for the document evaluation and the preparation of the report for environmental behaviour and ecotoxicology of biocidal products in accordance with the provisions of Annex no. 2 to Order of the Minister of Health, Ministry for the Environment and Climate Change, National Veterinary Health and Food Safety Authority 10/205/19/2013 on tariffs charged by competent authorities for activities related to procedures for placing biocidal products on the market,, in the account communicated by the ANPM.”

14. In article 5, subparagraph 51 is repealed.

15. In article 5, paragraph 6 is amended to read as follows:

“6. Within 180 days from the submission of documents required by Art. 71 and 72 of this Order, the experts prepare the evaluation report in order to maintain the authorisation for TP 1-TP 4 products and submit it to CNPB for the purpose of the application of the provisions of Art. 9 (2) and (3).”

16. In article 6(1), subparagraphs b) and c) shall be amended to read as follows:

“b) experts nominated by the Institute for the Control of Biological Products and Medicinal Products for Veterinary Use shall draw up the evaluation reports with the data referred to in Article 4(1), with the exception of the ecotoxicological data and environmental behaviour referred to in point c), for 3, 4, 5 product-types intended for drinking water for animals and for type 20, as set out in Annex V to Regulation (EU) No 528/2012 on the making available on the market and use of biocidal products, as amended;”

“c) experts nominated by the National Environmental Protection Agency, on the basis of the documents referred to in Article 4(1), shall draw up the evaluation reports on ecotoxicology and environmental behaviour for all product types referred to in Annex V to 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”

17. In article 71, paragraph 2 is repealed.

18. In Article 72, paragraph 1 is amended to read as follows:

“1. For biocidal products of TP 3 and TP 4 type, authorisation holders submit other biocidal effectiveness test reports 10 years after the first authorisation, in accordance with the requirements laid down in Article 4(1) subparagraphs g^1) and g^2) of this Order.’

19. In article 72, paragraph 2 is repealed.

20. In article 8, paragraph 1 is amended to read as follows:

(1) Before placing a biocidal product on the market with dates other than those stated in the authorisation, it shall be mandatory for the applicant to submit an application for an extension authorisation, in compliance with Article 2 subparagraph (b), in conjunction with Article 5(4) of this Order.”

21. In Article 9 after paragraph 1, two new subparagraphs 11 and 12 are inserted and shall read as follows:

“11. The administrative amendment to an authorisation consisting of the amendment of the applicant shall be approved by the CNPB, based on the application submitted by the manufacturer of the biocidal product, accompanied by the revocation of the power of attorney referred to in Article 4(1)i) and the power of attorney for the new applicant as defined in Article 2f).”

“12. CNPB cancels an authorisation:

following a final and irrevocable decision of a court or tribunal, where it is found that the authorisation was granted on the basis of information which does not reflect the facts

at the request of the 'applicant' as defined in Article 2f) of this Order”

22. In Article 9, paragraph 2 is amended to read as follows:

“(2) The indication for use in healthcare facilities of the authorisations for biocidal products belonging to main group 1: Disinfectants, TP 1 and TP 2 product types are deleted if approval holders do not comply with Article 4(1) subparagraph g1), g2), g6) and of Art. 71. ”

23. In article 9, a new paragraph 6 shall be inserted after paragraph 5, with the following content:

“6. The distributor shall apply for approval of a biocidal product if:

a) it places the product on the market under its name or trademark;

b) it alters, by means of split-packing, (re)packaging and re-labelling operations, a product already placed on the market, in such a way as to have an impact on the compliance with the authorisation documents, unless the manufacturer or the holder of the authorisation provides the CNPB with written acceptance that such operations are part of his manufacturing process.”

24. Annex 1 is amended and replaced by the Annex which is an integrated part of this Order.

Article II - This order shall be published in the Official Gazette of Romania, Part I.

MINISTER OF HEALTH

MINISTER OF THE ENVIRONMENT WATER AND FORESTRY CHAIR OF THE NATIONAL SANITARY VETERINARY AND FOOD SAFETY AUTHORITY

ANNEX No 1

Company ………………………………,

as manufacturer |_•, representative of the manufacturer |_•, authorised importer |_•, I request the issuing of an authorisation on the placing on the Romanian market of the biocidal product......................................

. . . . . . . . . . (trade name)
Order 2217/2023 2217/2039/123 amending and completing Order No 10/368/11/2010 of the Minister of Health, the Minister of Environment and Forests and the President of the National Sanitary Veterinary and Food Safety Authority approving the authorisation procedure for biocidal products placed on the Romanian market

Order 2217/2023 of 10/5/2023

Status: Acts in force

Version from: 5 October 2023

Enters into force:

5 October 2023

Order 2217/2023 amending and completing Order No 10/368/11/2010 of the Minister of Health, the Minister of Environment and Forests and the President of the National Sanitary Veterinary and Food Safety Authority approving the authorisation procedure for biocidal products placed on the Romanian market

Date of the act: 30-June-2023

Issuer: MINISTRY OF HEALTH

Having regard to the approval report No AR 11.629/2023 of the General Directorate of Public Health and Health Programmes of the Ministry of Health,

Considering the provisions of Article 11 of Government Decision No 617/2014 on establishing the institutional framework and measures for implementing 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, as subsequently amended and supplemented;

Pursuant to Article 7(4) of Government Decision No 144/2010 regarding the organisation and operation of the Ministry of Health, as subsequently amended and supplemented, Article 13(4) of Government Decision No 43/2020 regarding the organisation and operation of the Ministry of the Environment, Water and Forests, as subsequently amended and supplemented, and Article 4(3) of Government Decision No 1.415/2009 regarding the organisation and operation of the National Sanitary Veterinary and Food Safety Authority and its subordinated facilities, as subsequently amended and supplemented;

The Minister of Health, the Minister of the Environment, Water and Forests and the President of the National Sanitary Veterinary and Food Safety Authority hereby issue the following order:

Article I

Order No 10/368/11/2010 of the Minister of Health, Minister of the Environment and Forests and President of the National Sanitary Veterinary and Food Safety Authority approving the authorisation procedure for biocidal products that are placed on the Romanian market, published in the Official Gazette of Romania, Part I, No 196 of 29 March 2010, as subsequently amended and supplemented, is hereby amended and supplemented as follows:

1. Article 1 shall be amended to read as follows:

’Article 1.

1. The procedure for the authorisation of biocidal products that are made available on the market on the territory of Romania is hereby approved, in accordance with Article 89(2) 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, as subsequently amended and supplemented.

2. The authorisation procedure for making available on the market or use shall apply to biocidal products containing:

a) only existing active substances that have been evaluated or are being evaluated under Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council, but have not been approved yet for that product type; or

b) a combination of the active substances referred to in point (a) with active substances approved in accordance with Regulation (UE) No 528/2012.’

2. In article 2, point f) shall be amended to read as follows:

‘f) applicant: legal person intending to place a biocidal product on the Romanian market;’

3. In Article 2, after point f), 6 new points g)-l) are inserted, reading as follows:

‘g) distributor: legal entity making available on the Romanian market an authorised biocidal product;

h) administrative amendment: an amendment to an existing authorisation, consisting of changing the data set out in Chapters I, II and III of the model authorisation set out in Annex 2 to this Order, without any impact on the properties or efficacy of the biocidal product;