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In most developed countries, all the chemical components of a Biocide must be listed on the relevant national “inventory” of chemical substances before it can be supplied. In addition, the usage of Biocides in precise applications such as skin-contact applications, will always be subject to additional legislation which often requires a specific product registration.
In the USA for example, Biocides are listed on the national inventory of chemical substances which is called TSCA. Alongside the listing on TSCA, there are regulations governing the use of biocides on both the federal (EPA or FDA for skin contact applications) and state level. In Europe, the regulations governing the use of Biocides are via the Biocides Products Directive. There are some exceptions such as with some specialist applications e.g. Cosmetics. For the rest of world, countries have their own regulations governing the use of Biocides or rely on the Biocides to have BPD / EPA approval. The time taken to achieve approval is normally by the regulatory body is normally two years and requires suppliers to make a substantial commitment to the biocide.
European Biocides Products Directive
The European Biocidal Product Directive determines a step-wise assessment of “existing biocidal active substances” placed on the market before 14 May 2000. Only those active substances that conform with the requirements are included in the active substances lists of annex I (authorised active substances) of the directive. The existing active substances will be evaluated up to the year 2013.
Biocidal Products are assigned to one of 23 different product types (PT), which are described in Annex V of the EU biocide directive. These PTs are divided into four main groups:
Disinfectants and general biocidal products (human hygiene, privat and public health area, veterinary hygiene, food and feed area, drinking water disinfectants)
Preservatives (e.g. in-can or film preservatives, wood preservatives, preservatives for fibres, leather, rubber, masonry, biocides for liquid-cooling and processing systems, slimicides, and metalworking-fluids biocides).
Pest control (rodenticides, avicides, molluscicides, piscicides, insecticides and products against other arthropods, repellents and attractants)
Other biocidal products (preservatives for food or feedstocks, antifouling products, embalming and taxidermist fluids, control of other vertebrates)
The assessment of active substances, has been allocated to competent authorities of the 25 EU member states. Annex V provide details of the deadlines for submission of a full dossier to the EU member state. The European Chemicals Agency (ECHA) will be responsible for handling all new biocide approvals from 2012. More information can be provided on http://ec.europa.eu/environment/biocides/index.htm biocides.
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