Joint Order No. 114 of the Ministry of Health, the Ministry of Environment and Water Management and the National Sanitary Veterinary and Food Safety Authority validating the Regulation on composition and functioning of the National Commission for Biocidal Products.
Country
Type of law
Regulation
Abstract
This Joint Order establishes the composition and functioning of the National Commission for Biocidal Products set up as specialized body for the fulfillment of the attributions regarding the authorization and registration of biocidal products on the Romanian territory and the decision-making process regarding the issuance of authorizations for biocidal products. The Commission shall have the following duties and responsibilities: (a) issuance of administrative acts for the placing on the market of new biocidal products, in compliance with existing assessment procedures; (b) decision-making on one of the following conclusions when making an authorization or registration for each type of product and each field of use of a biocidal product, for which an application has been submitted: (1) the biocidal product may not be authorized or registered; (2) the biocidal product may be authorized subject to specific conditions or restrictions; (3) additional information is required before the authorization decision is taken; (c) compliance with the principles of mutual recognition on the placing of biocidal products on the market; (d) application of the rules on the concept of the framework formulation when taking a decision to authorize a biocidal product; and (e) application of the rules on the concept of "low-risk biocidal product" when taking a decision to authorize a biocidal product or the concept of environmentally friendly product containing active substances evaluated and accepted at European Union level. In taking decisions, it shall take into account the following aspects: (a) the results of the risk assessment, in particular the relationship between exposure and effect, efficacy of biocidal products and benefits resulting from the use of the biocidal product; (b) correct use and application of the biocidal products; (c) verification of submittal by the applicant label and a safety data sheet for biocidal products proposed for registration and authorization; (d) examination of the effects of the biocidal product on humans, animals and the environment in order to reach an overall conclusion on the overall effect of the biocide; and (e) preparation of reports and information and facilitate the exchange of scientific data and information for the Member States of the European Union and the European Commission.
Attached files
Web site
Date of text
Repealed
No
Source language
English
Legislation Amendment
No
Original title
ORDIN nr. 114 din 8 noiembrie 2005 pentru aprobarea componenţei Comisiei Naţionale pentru Produse Biocide şi a regulamentului de organizare şi funcţionare a acesteia.