National authorisation of biocidal products placed on the market in Romania.

ORDER to amend and supplement Order No 10/368/2010 of the Minister for Health, Minister for the Environment and Forests and President of the National Sanitary Veterinary and Food Safety Authority approving the authorisation procedure for biocidal products that are made available on the market in Romania, as well as to amend and supplement Order No 961/2016 approving the Technical regulations with regard to cleaning, disinfection and sterilisation in public and private healthcare facilities, the working and interpretation technique for the tests used to assess the efficacy of the cleaning and disinfection procedure, the procedures recommended for hand disinfection depending on the level of risk, the methods for applying chemical disinfectants depending on the surface to be treated, and the methods used to assess the progress and efficiency of the sterilisation process

This legislative act regulates the following amendments and additions to Order No 10/368/2010 of the Minister for Health, Minister for the Environment and Forests and President of the National Sanitary Veterinary and Food Safety Authority approving the authorisation procedure for biocidal products that are made available on the market in Romania, as well as to amend and supplement Order No 961/2016 approving the Technical regulations with regard to cleaning, disinfection and sterilisation in public and private healthcare facilities, the working and interpretation technique for the tests used to assess the efficacy of the cleaning and disinfection procedure, the procedures recommended for hand disinfection depending on the level of risk, the methods for applying chemical disinfectants depending on the surface to be treated, and the methods used to assess the progress and efficiency of the sterilisation process, as follows:

- test reports which demonstrate biocidal efficacy shall be drawn up in accordance with the methods developed by the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN);

- for biocidal products belonging to Main group 1: Disinfectants, Product Types PT1 with indication for use in healthcare facilities, PT2 with indication for use in healthcare facilities, PT3 and PT 4, the products shall be assessed and their efficacy shall be demonstrated in accordance with EN 14885:2015 ‘Application of European Standards for chemical disinfectants and antiseptics’ or, if the laboratory methods used to demonstrate the efficacy are not stipulated in EN 14885:2015, the document entitled ‘Transitional Guidance on Efficacy Assessment for Product Types 1-5, Disinfectants’, with its subsequent amendments and additions (available on the website of the European Chemicals Agency (ECHA));

- the test reports stipulated for authorisation must be issued after the date of publication of EN 14885:2015;

- the indication for use in healthcare facilities of the authorisations for biocidal products belonging to Main group 1: Disinfectants, Product Types PT1 and PT2 shall be removed if the authorisation holders do not comply with the provisions of Article 4(1)(g3), (g2), (g3) and (g5);

- for the period of grace required in order to make available on the market and use the existing stocks of biocidal products subject to the provisions stipulated in Article 9(1), (2) and (3), the provisions of Article 52 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, with its subsequent amendments and additions, shall apply;

- the indication for use in healthcare facilities shall be valid up to 3 years from the issue date of the authorisation.

- any infringement of the provisions of Article 95 of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products by the holders of authorisations issued in accordance with this order, which has been established by the State Sanitary Inspectorate attached to the Ministry of Health, the National Environmental Guard and the National Sanitary Veterinary and Food Safety Authority in accordance with their competencies and has been notified to the Commission, shall lead to cancellation of the authorisation.

Key words: marketing authorisations, biocide