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) and state level. In Europe, the regulations governing the use of Biocides are on a countrywide level. For the rest of world, countries have their own regulations governing the use of Biocides or rely on the Biocides to have EPA approval.

The following list of countries have established regulatory requirements for Biocides. For countries which are not listed, this should not be interpreted as meaning that sales are permitted without further regulatory action as some of those countries may require an import certificate of some sort or letter of no objection such as for Taiwan. The following table illustrates which countries regulate the use of Biocides:

Countries which Regulate Biocides

The approval by the regulatory body can take up to two years and requires suppliers to make a substantial commitment to the biocide.
 

European Biocides Products Directive

As stated previously, each European country currently regulates the use of biocides within their region but this is changing with the European Biocides Product 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 2010.

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)

On July 9th 2005, 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. More information can be provided on http://ec.europa.eu/environment/biocides/index.htm biocides.