Applying to all biocidal products, eu regulation 5282012 biocidal products regulation bpr1 came into force in september 20. In order that active substances may be used as or for biocidal products. The european unions new regulation on biocides european union law on biocidal products has been revised. Our bpr portal provides our customers with the right resources to comply with legislation. Notwithstanding the first subparagraph, when a biocidal product falls within the scope of one of the abovementioned instruments and is intended to be used for purposes not covered by those instruments, this regulation shall also apply to that biocidal product insofar as those purposes are not addressed by those instruments. Regulation eu no 5282012 of the european parliament and of the council of 22 may 2012 concerning the making available on the market and use of biocidal products text with eea relevance the european parliament and the council of the european union, having regard to the treaty on the functioning of the european.
The biocidal products regulation bpr, regulation eu 5282012 concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product. The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Only authorized products are allowed to be sold on the market. The following diagram outlines the key time points in the authorization process. The biocidal products regulation bpr, regulation eu 5282012 concerns the placing on the market and use of biocidal products. Practical guide on biocidal products regulation same. Regulation eu no 5282012 of the european parliament and of.
Biocidal products regulation bpr the new biocidal products regulation bpr pecons 312, available online here, was adopted on may 10, 2012, and entered into force on september 1, 20. The biocidal product regulation bpr eu 5282012 on the use and placing on the market of biocidal products repealed and replaced the biocidal product directive bpd on biocides 988ec on 1 september 20. Biocidal products regulation msl solution providers. From the perspective of environmental and consumer protection, the new.
Biocidal products regulation compliance notification of product discontinuation. The biocidal product regulation has been in force in the eu since september 1, 20. Confusion may be too strong a word, but if the unification of regulation across the eu was an intention of the biocidal products regulation, you may question its success. Fertilizers regulation proposal, the biocidal product regulation. Checklist to comply with by karen rossington and eu. Same product authorization evoniks product tradename bp tm from 2020 the european biocidal product regulation bpr replaces old national regulations for hydrogen peroxide and peracetic acid. The 22 product types pts of the biocidal products regulation 5282012 back to beta this is a new way of showing guidance your feedback will help us improve it. The aim of the bpr is to improve the consistency of the biocidal products available in the eu and ensure a high level of protection for humans and the environment via a twostage process of active substance approval followed by biocidal product authorisation. In accordance with the biocidal products regulation bpr, regulation no. The eu biocides regulation 5282012 eu bpr covers a very diverse group of products. The new eu biocidal product regulation bpr changes the regulatory landscape webinar 11 september 2012 herb estreicher partner 202. If youre new to the world of biocides and the biocidal products regulation ec no 5282012 also known as the bpr you might hear people refer to the bpd, 988ec, identified and notified actives. Since the bpd was written as a directive, each eu member state was then responsible for implementing the bpd into their national law. Procedure to follow the type of sbp you can apply for depend on the type of reference authorisation.
As such, it focusses on use of bps in common automotive industry processes such as metalworking fluids and water. Directive directive regulation 988ec eu 5282012 annex i inclusion approval annex i list of approved substances annex ia annex i low risk products products eligible for the simplified. Cosmetics and biocides in the eu the science group. A biocidal product as defined by the biocidal products directive is a.
Information on authorisation and marketability of sodium. Authorising the supply and use of biocidal products. Almeida, in functional finishes for textiles, 2015. The eu biocides regulation 5282012 eu bpr biocides hse. Regulation on the supply and use of biocidal products. Often biocidal products contain mixtures of chemicals with different mechanisms. In urgent cases, please submit your question through the contact form. This guidance document deals with the risk assessment for human health and the environment of disinfection by products that is applicable for the authorisation of products under the eu biocidal products regulation bpr, regulation eu 5282012. It is estimated that 40,000 different biocidal products are on the market in the european union eu. The supply of articles treated with biocidal products. More than 20 years ago the biocidal product directive 988ec bdp was first drafted and in 20 the biocidal products regulation eu 5282012 bpr replaced the bpd. Subworking group for the biocidal product regulation during the development of this guidance. Details on this revisionreplacement can be found on.
If the answer is yes, then the product is a treated article. Ozone as active substance under the biocidal product. Practical guide on biocidal products regulation echa. Changes we have not yet applied to the text, can be found in the changes to legislation area. Biocidal products public health european commission. Detergent products and biocidal detergent products a detergent is any product intended for washing and cleaning. Biocidal products have been regulated in the european. Eu 5282012 biocidal product regulation bpr brenntag holding gmbh, biocidal product families for product authorization 31032017 19 go glossary of terms bpr. Union eu by the eu biocidal product regulation 5282012. The guidance on the biocidal products regulation part a information requirements is to be applied to applications for active substance approval and product authorisation as submitted from 1 september 20, the date of application doa of the biocidal product regulation the bpr. Practical guide on biocidal products regulation higiene ambiental. Subworking group for the biocidal product regulation very much appreciates the exchange of comments, suggestions and questions with the automotive industry task forcebiocides during the development of this guidance.
Dossier biocides and food contact materials food packaging. The biocidal products regulation bpr contains several provisions for nanomaterials nms and is the first regulation in the european union to require specific testing and risk assessment for the. Since september 1st, 2015 any biocidal product consisting of, containing, or generating a relevant substance, cannot be made available on the eu market, if the substance. The programme was set up under the biocidal products directive and continues under the bpr. The changes apply to products such as disinfectants, household pesticides, or wood preservatives and to articles treated with biocidal products. Apr 03, 2015 union authorisation of biocidal products possible harmonised summary of the product characteristics for authorisation regulation vs. European biocidal products regulation, bpr citrefine. The aigbpr is intended to provide practical help to the automotive industry. This regulation should apply to biocidal products that, in the form in which they are supplied to the user, consist of, contain or. The bpr defines the marketing authorization procedure for biocidal products. Where a product has a biocidal function that is inherent to its cosmetic function, or where that biocidal function is considered to be a secondary claim of a cosmetic product and is therefore regulated under regulation ec no 12232009 of the european parliament and of the council of 30 november 2009 on cosmetic products 8, that function and. It may be sold for household or for institutional or industrial purposes in many forms such as. The eu biocides regulation 5282012 eu bpr covers a very diverse group of products, including disinfectants, pest control products and preservatives this section outlines the process you must follow to gain authorisation for a biocidal product biocidal product family or approval of an active substance under eu bpr. The bpr will repeal and replace the current biocidal products directive directive 988ec and will make some significant changes to the way biocidal products or non agricultural pesticides are.
European biocidal product regulation factsheet biocides. The eus regulatory framework for biocides changed in. The european biocidal products regulation bpr controls the use of all biocides substances or microorganisms which deter, render harmless, or exert a controlling effect on any harmful organism like a bug spray which stops mosquitoes from biting manufactured or sold within the european union. Mar 07, 2017 if the answer is yes, then the product is a treated article. This document is part of a series of documents which describe the bpr obligations and how to fulfil them. Regulation eu no 5282012 of the european parliament and of the council. Union authorisation of biocidal products possible harmonised summary of the product characteristics for authorisation regulation vs. Second, duties under the bpr apply also where an article is treated with a biocidal product but where it. Ecotoxicological data are one of the pillars of the information requirements in the bpr, but there are currently no standard. The guidance on the biocidal products regulation is to be applied to applications for active substance approval and product authorisation as submitted from 1 september 20, the date of application of the biocidal product regulation the bpr. Labelling and packaging requirements for detergents. The biocidal products regulation bpr, regulation eu 5282012 concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of. In particular, it says that a biocidal product cannot be placed on the market or used unless it contains approved active substances, and has been authorised.
Information on authorisation and marketability of sodium hypochlorite biocidal products page 1 of 5 background the biocidal product regulation eu 5282012 bpr regulates the conditions for making available on the market and use of biocidal products in the european union. The biocidal products regulation bpr is a piece of eu legislation released in 2012 replacing. The classification of biocides in the biocidal products regulation eu 5282012bpr is broken down into 22 product types i. New biocidal products that contain active substanceproduct type. The regulation is designed to control the selling or placing on the market of biocidal products. He has a wealth of experience with eu regulation of biocidal products, plant protection products. Some of the key changes under the revised biocidal products regulation are summarised below. Checklist to comply with by karen rossington and eu biocidal.
Biocidal active substances anmeldestelle chemikalien. Overview of biocide regulations in oecd member countries this document provides an overview of biocide regulation in oecd member countries indicating for each member country. The guidance on the biocidal products regulation bpr is to be applied to applications for active substance. A simplified biocidal product authorization conusbat. Biocidal products regulation cleaning up the marketplace.
Biocidal product regulation dupont nutrition and biosciences. The basic principle in the biocidal products regulation eu no 5282012. It involves the analysis of a biocidal products performance efficacy, toxicity, environmental fate and risk. The consolidated version of the regulation eu no 5282012 of the european parliament and of the council of 22 may 2012 concerning the making available on the market and use of biocidal products bpr incorporates all of the amendments and corrigenda to the bpr adopted to date. Challenges in implementing the biocidal product regulation bpr article pdf available in nanomaterials 62. The transition period has been extended up to 2024. Union eu by the eu biocidal product regulation 5282012 bpr since 1 september 20. Working group for the biocidal product regulation bpr. Practical guide on biocidal products regulation same biocidal product 111 will need to contact the case owner of the application for authorisation of the related reference product to obtain the relevant reference case number used in r4bp 3. The biocidal products regulation bpr contains several provisions for nanomaterials nms and is the first regulation in the european union to require specific testing and risk assessment for the nm form of a biocidal substance as a part of the information requirements. Consequently, a biocidal products committee should be established within the agency to carry out certain tasks conferred on the agency by this regulation. Important terms according to bpr, regulation eu 5282012 2. The new eu biocidal product regulation bpr changes the. This section outlines the process you must follow to gain authorisation for a biocidal product biocidal product family or approval of an active substance under eu bpr.
Once a biocidal product was authorised under the directive in one eu member state that authorisation could then be recognised in all other member states. The regulation on biocidal products requires all products to be authorised by a competent authority before they are placed on the market. The biocidal products regulations 2001 legislation. The echa website is temporarily down for maintenance. An overview of the eu biocide authorization process. Checklist to comply with eu biocidal products regulation 5282012. A lot of the changes are procedural, but the extension to the scope was important because it impacted industries that previously had no biociderelated obligations. The 22 product types pts of the biocidal products regulation 5282012 back to beta. Authorities can only grant authorisation if the evaluation they carried out shows that the use of the product is safe for human and animal health, and the environment. Same biocidal product a biocidal productfamily which is identical to a related reference productfamily, as per commission implementing regulation eu no 41420 of 6 may 20 specifying a procedure for the authorisation of same biocidal products in accordance with regulation eu no 5282012. The biocidal products regulation eu 5282012 bpr came into force on 1 september 20 repealing the biocidal product.
Practical introduction to the biocidal products regulation. The bpr will repeal and replace the current biocidal products directive directive 988ec and will make some significant changes to the way biocidal. The european biocidal products regulation eu no 5282012 bpr sets rules in the eu for approval of active substances ass, authorisation of biocidal product bps, and placing treated. The eu biocides regulation 5282012 eu bpr covers a very diverse group of products, including disinfectants, pest control products and preservatives this section outlines the process you must follow to gain authorisation for a biocidal productbiocidal product family or. European union law on biocidal products has been revised. Consolidated version of the biocidal products regulation. Overview of biocide regulations in oecd member countries. We are writing to inform you that the above product ranges will be phased out at the. Regulation eu no 5282012 of the european parliament and. Focuses on eu chemicals regulation biocides, agrochemicals, and reach, working closely with the european commission ec and national competent authorities in the eu european commission experience with drafting eu chemicals regulation e. Once a biocidal product was authorised under the directive in one eu member state that authorisation could then be recognised in all other member.
1395 34 1447 1285 635 688 415 568 1577 48 1239 546 245 736 429 920 1324 1063 1059 722 145 225 400 701 239 602 1125 218 1430 1216 672 781 515