European Biocidal Products Directive: Is it as simple as it sounds?
By Leonidas Dokos
Aug. 28, 2007 -- The European Biocidal Products Directive 98/8/EC, most commonly known as BPD, was adopted by the European Parliament and the Council in 1998 and came into force in 2000. It concerns the placing of biocidal products on the European market. The aim of the Directive was to harmonize the authorization of such products and their active ingredients between the member states of the European Union. The implementation period of the Directive is 10 years.
The Directive produced a formal definition of biocidal products as: "Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means."
In addition, an active substance is defined as: "A substance or micro-organism including a virus or a fungus having general or specific action on or against harmful organisms."
What Product Groups are Included?
Biocides are non-agricultural pesticides and the Directive defined four main groups, which are:
• Disinfectants and general biocidal products
• Preservatives
• Pest control
• Other biocidal products
Furthermore, these four groups include 23 product types. They are used in a variety of applications to control unwanted organisms. The targeted products range from human hygiene biocidal products and wood preservatives to insecticides and preservatives for food or feedstocks.
BPD's Wide Scope Creates Industry Confusion
As the BPD has a wide scope it frequently creates confusion with other existing EU Directives. Its borderlines with the Cosmetic Products Directive (CPD) 76/768/EEC amended by Directive 2000/41/EC, the Proprietary Medicinal Products Directive 2001/83/EC amended by Directive 2004/24/EC, the Veterinary Medicinal Products Directive 2001/82/EC, and the Plant Protection Products Directive (PPPD) 91/414/EEC, are not always clearly understood and distinguished. Products that contain biocidal active substances or formulations and perform a dual functionality can represent a challenge in classifying them accordingly. This situation can lead to a marketing perplexity.
For example a water-based paint emulsion, which contains in-can preservatives to maintain the integrity of the paint, does not need authorization under the BPD. However, the in-can preservatives do require authorization under the BPD and this is the responsibility of the manufacturer, formulator or importer of the preservatives as they are considered biocidal products type 6.
Since the identification of a product whether is a biocidal product or a medical/pharmaceutical, cosmetic, and even plant protection product can be quite difficult, the intended purpose of the product and the claims of its use are of outmost importance.
In addition, importers of biocidal products and relevant active substances in the EU member states often do not know if they need to put their products through the BPD process. The result is that a large part within the industry believes that BPD added an extra layer of bureaucracy and confusion.
BPD's Complexity Results in a Long Implementation Period
The nature of BPD is by default very complex as its primary objective is to harmonize the legislation of EU Member States concerning this type of chemical substances. Hence, its implementation is divided in 4 phases over a time period of 10 years.
The crucial step in the implementation of the BPD was the creation of a list with the existing active substances. The existing active substances are substances which have been on the EU market for biodidal purposes before the 14th May 2000. Any other active substance, which has been introduced in the market after the 14th may 2000, is regarded as a new active substance. The new active substances need to be approved by the member states before they are included in the BPD list.
The first phase involved the identification, notification and establishment of a thorough list of active substances used in wood preservatives and rodencides. Complete dossiers for the active substances that were supported by the industry were submitted to the competent authorities of the rapporteur member states and the phase was completed in 2004.
The second phase involved the same process for molluscicides, insecticides, acaricides, products to control other arthropods, repellents, attractants and antifouling products. It was completed in 2006 resulting in an amendment of the annexes of BPD and included the active substances that were eventually notified and supported by the industry. The placing in the European market of biocidal products, which contain active substances not notified or not supported by the industry, will cease on 31st December 2007.
The third phase of the review program of the BPD concerns human hygiene biocidal products, private/public health area disinfectants, veterinary hygiene biocidal products, food and feed area disinfectants, drinking water disinfectants, in-can preservatives and metalworking-fluid preservatives. This phase was completed in 31st July 2007.
Finally, the fourth phase of the review program of the BPD targets the remaining product types consisting of film preservatives, preservatives for fibre, leather, rubber and polymerized materials, masonry preservatives, preservatives for liquid-cooling and processing systems, slimicides, avicides, piscicides, preservatives for food or feedstocks, embalming and taxidermist fluids and biocidal products for the control of other vertebrates. The fourth phase will be completed towards the end of 2008.
The BPD Promotes Innovation
The industry believes that phasing out more than 60.0 per cent of the active ingredients and thus biocidal products, which are based on them and are used at present, is not exactly promotion of innovation. The proverbial phrase "it will get worse before it will get better" describes in the most graphical way the current situation in the European market for biocidal products irrespectively of their application. The industry consensus is that the support of products through BPD makes new molecule research prohibitive and as a result it has been slowed down.
Until now the actual innovation has been achieved by few multinational chemical companies with strong financial and R&D resources for developing new active ingredients or supporting existing active substances with complete dossiers of data. A number of companies, which are active in the market, have refocused their commercial activities outside the European Union where their products are not accountable to BPD.
The Cost of Implementation
There are uncertainties in the cost estimates for the implementation of the BPD. The cost depends on the biocidal product type and if the active substance is new or existing. In addition, the costs also depend on the rapporteur member state that is responsible for approving active substances. The costs include charges that need to be paid to the rapporteur member state competent authority for carrying out the different procedures associated with the provisions of the BPD.
Finally, the additional costs of further researching and producing a complete dossier of data for evaluation under the BPD are quite significant. The average cost of providing data on biocidal product is estimated to be €147,000.
Is REACH the Big Bad Brother of BPD?
The REACH legislation which came into force from 1st June 2007 has created considerable additional scepticism in the European chemicals and subsequently biocidal products industry. The compounds and substances used in biocidal formulations and products vary annually in volumetric quantities. According to REACH legislation all chemicals will have a registration deadline until 2016-2017.
The industry believes that REACH could also affect the economics of biocidal products and slow down furthermore the European market. A possible increase in costs and the time needed to go through an additional registration process could have an impact on companies active in the market. Companies could see their profits shrink or even put them out of the market all together.
Conclusions
In conclusion, the European Biocidal Products Directive is expected to impact dramatically the European market for biocidal products and active substances. Although, its primary scope is to protect the people and the environment in the European Union, the industry has major concerns over the efficiency and effectiveness of the BPD process. As the provision of data for active substances and preparation is a costly and time and resource-consuming process, the regulatory approval can be delayed. Undoubtedly, the result will be the withdrawal of many biocidal products in the review process, something that already is a reality.
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Also see:
-- "Schneider Electric SA: Increasing Presence in the Brazilian Automation Market"
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