A directive on the placing of biocidal products on the market was considered the most appropriate way to establish such a framework. Eu biocidal products regulation and its impact on industry. In germany alone, more than 35 000 biocidal products fall under the directive. Regulation eu no 5282012 of the european parliament and. Unlike the previous biocidal products legislation, socalled insitu procedures such as. An addendum on how to obtain beat including a password. This includes mixtures, articles and materials treated with biocidal products, including furniture and textiles, as well as a provision on dual use covering biocidal products that have a dual function. Most of the biocidal products currently on the market have not been authorised according to procedures as defined in the current directive. Directive 988ec concerning the placing biocidal products. Biocidal product regulations, what you need to know debugged. General principles for combining clp and bpr labelling. The programme was set up under the biocidal products directive.
It is officially known as directive 988ec of the european parliament and of the council of 16 february 1998 concerning the placing of biocidal products on the market. The biocidal products regulation, no 5282012 bpr took effect on 1 september 20 and repeals the previous biocidal products directive directive 988ec. European commission press release details page european commission memo brussels, 17 july 2012 the new regulation on the use and placing on the market of biocidal products will repeal and replace the current directive on biocides 988ec. Technical notes for guidance tnsg and other technical guidance documents were developed for the implementation of the biocidal products directive 988ec bpd to enable industry and competent authorities to fulfil their requirements under the bpd.
The biocidal products regulations 2001 legislation. The biocidal products regulation bpr is an eu regulation no 5282012 concerning the placing on the market of biocidal products. The bpr repeals and replaces the previous biocidal products directive 988ec bpd. A new version of the bpr regulation was published in 2012 regulation 5282012 and repealed the biocidal products directive directive 988ec from 1 september 20. At the end of this oneday course participants will have a thorough understanding of the practical implications for eu manufacturers and importers of biocidal products and articles treated with biocidal products, and how to apply it to their own area of work. Background to the biocidal products directive 988ec.
Directive 988ec of the european parliament and of the council of 16 february 1998 concerning the placing of biocidal products on the market. Biocidal product directive an overview sciencedirect. The authorisation of biocidal products under the bpr. The registry involved two steps, first winning approval in the member state and also within the eu.
The most recent version is of 2008 which includes an excel file containing default exposure data for all pts. In many parts of the world, hygiene is still a critical challenge, and lives are. Main issues on the further development of the ec biocidal. Biocidal product regulation and regulatory consultancy blutest has extensive knowledge of regulatory systems, particularly the biocidal products regulation and the cosmetics directive in europe and those administered by the epa in the united states. Foodstuffs acquire a sickly sweet smell and an unpalatable taste. This paper outlines the requirements of directive 988ec the biocidal products directive and the effect that implementation of the directive is likely to have on the market for, and development of, biocides. Practical guide on biocidal products regulation echa. However, they are widely used and can pose adverse effects to human health and biodiversity. As a regulation, rather than a directive, the bpr is directly acting in the 28 eu member states, meaning that local legislation does not need to be created to implement it in each member state. Product type 2private area and public health area disinfectants and other biocidal products product type 3veterinary hygiene biocidal products product type 4food and feed area disinfectants product type 5drinking water disinfectants. Impact of the european biocidal products regulation.
The biocidal products directive 988ec bpd does not take into account. Biocidal products are used to control unwanted organisms that are harmful to human or animal health or to the environment, or that cause damage to human activities. It also explains the guiding principles for the evaluation of the applications to be performed by the authorities. While the formulation treated with biocidal products leaves little room for interpretation, the question arises as to how the expression to. Due to the active substances contained within them, biocidal products exert a controlling effect on harmful organisms such as insects, bacteria or algae. The tnsg on human exposure document 2007 provides guidance on the estimation of human exposure to biocidal products for all product types. Regulation on the supply and use of biocidal products. Current european legislation on biocides biocidal products.
Biocidenrichtlijn superseded biocides guidance documents. Transitional guidance on the biocidal products regulation. Scope of the directive the scope of the bpd is determined by three elements. As in the previous directive directive 988ec, the approval of active substances takes place at eu level, and the subsequent authorisation of the biocidal products at the member state level. Directive 988ec the biocidal products directive, bpd of the european parliament and of the council of 16 february 1998 concerning the placing of biocidal products on the market entered into force on 14 may 1998. Guidance and other relevant documents on the implementation of directive 988ec. Numerous biocidal product dossiers, including frame formulations, prepared and submitted by csi, have received authorisation throughout europe. An authorisation can be extended to other member states by mutual recognition mr, and the new regulation also provides for biocidal product family. The biocidal products amendment regulations northern. The eu biocidal products directive and the consequences for. It describes the main steps in the ittool register for biocidal products r4bp 3, to communicate and exchange information with other member state competent authorities, the european chemicals agency echa or the commission.
It describes the main steps in the ittool register for biocidal products r4bp 3, communication and exchange of information with other member state competent authorities, the european chemicals agency echa or the commission. The new eu rules on articles treated with biocidal products. The bpd was subsequently repealed and replaced by the biocidal products regulation, or bpr 3, in 2012. Evaluation manual for the authorisation of biocides general. Member states had to implement it not later than 24 months after its entry into force. The eu biocidal products directive and the consequences. The regulation outlines the general principles and products which fall under the scope of the biocidal products regulation. Member states shall prescribe that a biocidal product.
Directive 200747ec of the european parliament and of the council of. Biocidal products regulation regulation eu no 5282012. Under the bpr the active substances in the biocidal products must be approved for the product type in which they are used. The biocidal products directive 988ec established an authorisation scheme to ensure that active substances and biocidal products are assessed so that they are safe for people to use, and will not harm the environment, before they are placed on the market. The echa guidance on biocides legislation describes how to fulfil the information requirements set by the biocidal products regulation, regulation eu 5282012 bpr and how to perform the required assessments. These regulations a implement directive 2009107ec of the european parliament and of the council of 16 september 2009 amending directive 988ec concerning the placing of biocidal products. Relevance for the footwear sector since the adoption of eu regulation 5282012 biocide regulation, which replaces the biocide. Regulation replacing the bpd biocidal product directive 988ec. Dow microbial control, a business group of the dow chemical company, has announced that its active substance dcoit4,5dichloro2octyl2hisothiazol3one has been recommended by the eu competent authority for approval and inclusion into the annex i of the biocidal products directive for product type 21. Directive 988ec concerning the placing biocidal products on. Biocidal product regulation and regulatory consultancy. The date of applicability of the regulation is 1 september. The responsibility for placing biocidal products on the market falls to the authorisation holder. It is necessary to adapt those rules in the light of experience and in particular the report on the first seven years of the implementation submitted by the.
Bps authorised in accordance with article 3 or 4 of directive 988ec. According to article 2 1 of the directive 988ec biocidal products directive bpd. Biocidal products directive, 988ec what are biocidal products. We understand the complex needs of marketing and technical agendas and can manage this interface, ensuring that strong claims can be agreed upon that. This legislation will replace the biocidal products directive 988ec bpd. All biocidal products containing approved active substances are evaluated for safety and efficacy before they are allowed to. Pdf the biocide product directive bpd of the european union is intended to balance the efficacy of biocides in their intended use with their impact. The biocidal products directive bpd also known as the biocides directive is european union directive, 988ec, which concerns biocides. Eu evaluation manual for the authorisation of biocidal products manual of decisions. By 1 september 20, the bpr shall become applicable in all members states in the european union. Technical guidance note on comparative assessment of biocidal.
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. In 20 the biocidal products directive was superseded by the. New biocidal products regulation 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 such as pests or bacteria, by the action of the active substances contained in the biocidal product. Burchi t he new eu biocidal products regulation bpr, ec regulation 5282012, repeals and replaces the biocidal products directive 988ec, which regulated biocidal active substances and biocidal products in the eu. Regulations on products treated with biocides must be included in the directive in its present form, the bpd does not regulate the marketing of products treated with biocides or the import regulations and control of these products into the european union. Following intense negotiations, the longenvisaged european union eu biocidal products regulation bpr, was approved by the european parliament on 19 january 2012. The european biocidal products directive springerlink. New biocidal products regulation spetsinterproject. In many cases, they are not necessary for our safety. According to the court of justice, the concept of biocidal products within the meaning of article 21a of directive 988ec include products which act. Biocidal products regulation the european biocidal products regulation regulation eu no. The same deadline applied for active substances contained in biocidal products that were not considered as such under the former biocidal products directive.
The biocidal products directive and the necessity for. 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. Biocidal products may be placed on the market, be used professionally and commercially only if they have been authorised, notified or recognised according to the ordinance on biocidal products obp sr 8. Directive 988ec of the european parliament and of the council concerning the placing of biocidal products on the market was adopted on february 16, 1998 2, published in the official journal on april 24, 1998. Biocidal product regulation and regulatory consultancy blutest. Directive 988ec of the european parliament and of the. It is necessary to adapt those rules in the light of experience and in particular the report on the first seven years of the implementation submitted by the commission to the european. The eu regulatory framework for biocides has for years been defined by the directive 988ec, also known as the biocidal products directive bpd. Biocides are intended to combat harmful and unwanted organisms outside the agricultural context. Pdf concept and consequences of the eu biocide guideline.
Biocidal products regulation ebook linkedin slideshare. Blutest has extensive knowledge of regulatory systems, particularly the biocidal products regulation and the cosmetics directive in europe and those administered by the epa in the united states. All biocidal products to be placed on the market require an authorisation, and the active substances contained in that biocidal product should be previously approved. Article 53 of the regulation provides that, by december 20 at the latest, the commission had to adopt the delegated acts as regards the specification of. The bpd and the bpr are both based on a two phase process. The bpd was revoked by the biocidal products regulation 5282012 bpr, which entered into force on 17 july 2012 with the application date of september 1, 20. Overview of new biocidal product regulation impacts on. Commission regulation ec no 20322003 of 4 november 2003 on the second phase of the 10year work programme referred to in article 162 of directive 988ec of the european parliament and of the council concerning the placing of biocidal products on the market, and amending regulation ec no 18962000. Here you can find information on biocidal products authorised on the eueea market, in accordance with the biocidal products directive directive 988ec or the biocidal products regulation regulation eu no 5282012. Scope of the application of the biocidal products directive. Therefore, it is essential that comparative assessment at product authorisation or. 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.
1219 1677 1415 1629 1239 1612 34 1186 1587 192 48 1501 1438 1102 453 1484 833 62 626 399 1234 1171 1155 959 1284 918 1624 566 1113 1649 1013 269 509 1318 1398 567 9 694 433 917 513 983 465 90