Biocides are strictly regulated by the biocidal products directive bpd. Biocidal products regulation regulation eu no 5282012. Upcoming eu requirements on goods treated with biocidal. A working group has been established within the ministry of health with the aim of transposition of the directive. Biocides represent a diverse and highly specialised industry, with specialised and essential uses that provide enormous benefits to us, each day, many of which we take for granted. Guidance tnsg on data requirements eu, 2008a in support of directive 988ec biocidal product directive bpd.
To deliver the hard copies of the biocidal product license file to the ministry of health followup the application regularly to provide the additional information or documents requested by the ministry timely and correctly evaluation of the authority and licensing of biocidal product. Consequently, applicants should use this document when preparing dossiers according to. In 20 the biocidal products directive was superseded by the biocidal products regulation. Directive 988ec of the european parliament and of the council on the placing on the market of biocidal products. Labels shall not be misleading or give an exaggerated impression of the product and, in any case, not mention the indications lowrisk biocidal product, nontoxic, harmless or similar indications. Until september 20, biocidal products were regulated under the eu biocidal products directive of 1998. One such regulation is the biological products directive 988ec bpd which has been recently revised and is now designated as eu biocides regulation 5282012 eu bpr. In addition to the bpr guidance, the biocidal products directive bpd guidance and other related documents are still considered applicable for new submissions under the bpr in the areas where the bpr guidance is under preparation. In a guidance document doc biocides 200201 bpd biocidal products according to directive 988ec are defined as products used on animal skin during milking, such as teat dips or udder cleaning products, and may be used only after authorisation or registration in accordance with the procedures laid down in directive 988ec.
Importingexporting biocidal products and treated articles. However, excessive use of biocidal products can be harmful to humans and to the environment at large. This regulation aims at improving the functioning of the biocidal products market in the eu, while ensuring a high level of protection for humans and the environment2. Biocidenrichtlijn superseded biocides guidance documents. Regulation eu no 5282012, on the case law, such as case c42010 1, or on author itative guidance from the. 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. Eu evaluation manual for the authorisation of biocidal products manual of decisions. The biocidal products directive 988ec eu biocides regulation 5282012 developed by the european union is the most convenient method of classification of products involved in prevention of biodegradation and biodeterioration of products and materials. Biocidal products regulation was published in 2009 in turkey. The biocidal products directive also known as the biocides directive is european union directive, which concerns biocides.
According to annex v of the biocidal products directive 988ec bpd there. A biocidal product as defined by the biocidal products directive is a. This was superseded on september 1st 20 by the 2012 biocidal products regulation. Products directive 988 eg, the information in this manual may also be useful as. New regulation biocidal product regulation eu 5282012 o replaces the biocidal products directive 988ec adopted in may 2012 entered in the operation 1 september 20 link to the text via echa website. Under this legislation, active compounds are submitted for approval on the list of approved active substances.
Pdf progress on the biocidal products directive kjeld. Regulation of biocidal products and treated articles. Practical guide on biocidal products regulation echa european. The biocides directive was modelled after the plant protection products directive 91414cee concerns the placing on the eu market of biocidal products, i. Directive 200182ec of the european parliament and of the council of 6. Biocidal product directive an overview sciencedirect. Bpd directive 988ec of the european parliament and of the council of 16 february 1998 concerning the placing of biocidal products on the market biocidal products directive bpr 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. It is important to recognize the ozone did not fall under the former eu biocidal products directive 988ec bpd but is now regulated under the eu biocidal products regulation 5282012. Echa will revise this guidance document, where necessary, if this proposal is adopted. Biocidal products shall be labelled in accordance with the provisions relating to labelling in directive 88379eec. The biocidal products regulation, no 5282012 bpr took effect on 1 september 20 and repeals the previous biocidal products directive directive 988ec. Eu commission guidance documents guidance documents on treated articles, food contact materials fcm biocides, changing active substance source prior to 2015, classification and labelling of biocidal products and many more topics can be downloaded from the eu commissions circabc website communication and information resource centre for. Products directive 988eg, the information in this manual may also be useful as.
The biocidal products regulation bpr is a piece of eu legislation released in 2012 replacing. Practical introduction to the biocidal products regulation. Commission decision of 10 may 2012 concerning the noninclusion of dichlorvos for product type 18 in annex i, ia or ib to directive 988ec of the european parliament and of the council concerning the placing of biocidal products on the market notified under document c2012 3016text with. 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. Such approvals for dow products only reflect the markets into which it sells glutaraldehyde. Pdf nowadays, versatile human activity requires the development of technologies in the.
The new eu biocidal product regulation bpr changes the. Its widened scope and tightened provisions highlighted compliance concerns to the attention of aerospace and defence companies. The transition period has been extended up to 2024. Technical and economic feasibility of substitution.
Practical guidance on how to access information from the. Biocidal products regulation msl solution providers. Evaluation manual for the authorisation of biocides general. In many parts of the world, hygiene is still a critical challenge, and lives are. Pdf considerations on directive 988 of the european. 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. Biocidal products are regulated in the eu by the eu biocides regulation 5282012eu bpr, which repeals and updates the eu biocidal products directive bpd from 1 september 20.
The usage of biocidal products is, therefore, regulated under the directive 988ec of the european union eu, also known as the biocidal products directive, wherein these products are categorized into 22 types based on their application. The concept of socalled biocidal products has been introduced into the european. Other agencies may not list glutaraldehyde for certain applications, but this may simply reflect the fact that no application has been made by dow for these various listings. The programme was set up under the biocidal products directive. The scope of the regulation has been extended compared to the directive, to cover articles and materials treated with biocidal products treated articles, including furniture and textiles. Guidance on the biocidal products regulation, volume v, guidance on active microorganisms and biocidal products.
For getting information about our services, please click. Directive 200054ec on the protection of workers from risks related to exposure to biological agents at work 16. Superseding an existing eu biocidal products directive 988ec, the bpr aims to improve free movement of biocidal products in europe, protect health and the environment, harmonise implementation between member states, regulate imported products that contain biocidal active. Under the bpr the active substances in the biocidal products must be approved for the product type in which they are used. Label provision for treated articles under the biocidal products regulation bpr biocidal products in the eu are currently regulated by the biocidal products directive bpd. The biocidal products directive bpd also known as the biocides directive is european union. Due to the fact that ozone was brought to the market and used as a biocide before september 1 st, 20, it. In later years, consolidated regulation on biocidal products no. An inventory study for biocidal products has been initiated. Although the biocidal products directive does not regulate treated articles as such, the european commissions manual of decisions on the directive provides that articles treated with active biocidal substances are deemed to be biocidal products if the biocidal substances in the articles are intended to have an external effect. 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.
Chemicals biocidal products studies and progress contd assessments of the existing legal, institutional and administrative structures have been initiated. The new eu biocidal product regulation bpr changes the regulatory landscape webinar 11 september 2012 herb estreicher partner. This document is part of a series of documents which describe the bpr obligations and how to fulfil them. The bpr lays down rules and procedures for the approval of biocidal active substances and the authorisation of biocidal products. The commission has proposed a new regulation, the biocidal products regulation bpr, to replace the bpd. 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. If you are unsure as to whether the product you wish to importexport is a biocidal product, you should look at our law page. Biocidal products directive, 988ec what are biocidal products.
September 20, and replaces the previous biocidal products directive 988ec from 1998. Label provision for treated articles under the biocidal. Current uses of nanomaterials in biocidal products and treated. While the cost of preparing the file and the time for issuing a union authorisation is. Ozone as active substance under the biocidal product.
A treated article with a primary biocidal function is also con sidered a biocidal product. Overview of the biocidal product regulation 3 april 2015 tokyo, japan. Biocidal products containing active substances not identified or notified. In addition to these guidance documents, the manual of technical agreements containing agreements of the biocides technical meetings, the eu evaluation. European biocidal product regulation factsheet biocides.