Biocides and Plant Protection Products

The European Parliament and the Council adopted Directive 98/8/EC (EC 1998) in 1998 concerning the placing of biocidal products on the EU Market (Biocidal Product Directive, BPD) (EU 2006d, ECB 2006). 

The Directive covers 23 different product types specified in Annex V of the Directive. These include disinfectants used in different areas, chemicals used for preservation of products and materials, nonagricultural pesticides, and antifouhng products used on hulls of vessels. The Directive will not apply to certain product types already covered by other community legislation, such as plant protection products (PPPs) (Section 2.4.1.7.2), medicines, and cosmetics. 

The Directive requires an authorization process for biocidal products containing active substances listed in positive lists (Annexes I, lA, and IB of the Directive 98/8/EC). In relation to biocides, existing active substances are substances, which have been on the EU Market for biocidal purposes before 14 May 2000. An active substance, which was not on the market before 14 May 2000 is regarded as a new active substance and has to be approved by the Member States before it will be entered on the positive hsts. 

The notification procedure of existing active substances, which had started in 2000, was finalized on 31 January 2003. After having succeeded the notification procedure, the names of existing active substances have been published in the Official Journal of the European Communities (OJ). At the next step, the full dossier including aU test reports should be submitted to the Rapporteur Member State in agreed Data Formats including the risk assessment of the active substance. At the last step, the Rapporteur Member State in cooperation with all other Member States will decide whether the active substance wUl be entered onto the positive lists or not. 

More information on biocides can be obtained from the ECB Web site under the heading Biocides (ECB 2006). 

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As management of legislation on consumer and industrial chemicals, biocides and plant protection products has much in common, countries may find it advantageous to aspire to a high degree of co-ordination between these areas. 

Qualified scientific assessments of hazards and risks can be made by scientific institutions at universities or institutes contracted to provide assistance. As hazard and risk assessments of, for example, industrial chemicals, consumer chemicals, biocides and plant protection products have much in common, it would be cost efficient to co-ordinate and concentrate scientific support in order to avoid a thinning out of resources and expertise. 

CHIP is intended to protect people and the environment from the harmful effects of dangerous chemicals by making sure users are supplied with information about the dangers. Many chemicals such as cosmetics and medicines are outside the scope of CHIP and have their own specific regulatory regimes. However, biocides and plant protection products, which have their own specific laws, have to be classified and labelled according to CHIP as of July 2004. 

The basic idea of the CLH process is the transfer of responsibility for classification and labeling from industrial companies to authorities on a European Community level. In case of active substances in biocidal or plant protection products, all intrinsic properties including physicochemical properties, human health hazards, and environmental hazards are subject to the harmonization. By contrast, in the case of chemicals which are used in other application fields only some specific hazard classes are considered in the CLH procedure. According to Article 36 of the CLP Regulation, these are respiratory sensitization, carcinogenicity, germ cell mutagenicity, and reproductive toxicity. Consequently, these provisions have... 

Borderline between biocidal products and plant protection products,... 

In general, plant-protection products are biocidal active substances and are therefore by nature toxic to target organisms. At least some of them are also toxic to humans therefore, the safe use of plant-protection products presupposes, among other things, an evaluation of worker exposure during re-entry, an adequate risk assessment on the basis of the various practical scenarios in agriculture and horticulture, and, if necessary, specific instructions for worker protection on the product label. 

Mainly comprised of plant protection products and biocidal products, pesticides are designed to influence fundamental processes in living organisms. They may have the potential to kill or control harmful organisms such as pests, but can also cause unwanted adverse effects on non-target organisms, human health and the environment (EC 2007). Both the hazards and benefits of pesticides are well documented in published literature and have been reviewed most recently by Cooper and Dobson (2007). 

The Swedish National Chemicals Inspectorate (KEMI) has published an extensive review on human health risk assessment with focus on the application of assessment factors in risk assessments for plant protection products, industrial chemicals, and biocidal products within the European Union (KEMI 2003). 

FIGURE S.6 Schematic illustration of the traditional setting of an acceptable level of exposure (ADI) by dividing the NOAEL from an animal study by an assessment factor (AF). The two dose-response relationships have identical NOAEL. If a uniform assessment factor is applied, there will be an adequate MOS at the ADI for effect b but not for effect a. (Modified from KEMI, Human health risk assessment. Proposals for the use of assessment (uncertainty) factors. Application to risk assessment for plant protection products, industrial chemicals and biocidal products within the European Union. Report No. 1/03, Solna, Sweden, 2003. 

The BPD introduced a European scheme for authorisation of biocidal products. The Directive was closely based on an earlier authorisation directive dealing with plant protection products (agricultural pesticides). The context within which the Commission views biocidal products can be seen from the fact that the Directive was originally, in early drafts, called the Non-Agricultural Pesticides Directive . It is therefore not surprising that the Biocidal Products Directive introduces an onerous authorisation scheme that aligns with a previously stated EC requirement to reduce the number of pesticides on the EU market. The Directive came into force on 14 May 1998 and had to be implemented in all Member States within 2 years. Many Member States, including the UK, were late. 

To some extent, public institutions may be involved in hazard and risk assessments and decide on risk management, such as for (harmonised) classification and labelling of chemical substances, for authorisation of biocides and of plant protection products and for specific regulatory activities like bans or restrictions on the use of certain very hazardous chemicals. 

As noted above, modem legislation on chemicals allocates considerable responsibility to enterprises handling chemicals. Except for chemicals of special concern, such as plant protections products and biocides, current legislative systems applied internationally include very few elements of central steering of details. 

Adhesives Organic and inorganic bases Coolants Cleaners colorants (pigments and dyes) Fragrances Inks Paints Plasticisers (e.g., in plastics) Polymers (rubbers and plastics) Sealants Solvents Stabilisers Synthetic fibres Varnishes Biocides Detergents Fertilisers Fuels Foodstuff additives and flavourings to foodstuffs Medicinal products (for humans and animals) Plant protection products Radioactive substances... 

Food safety is a key issue in modern society, because we are exposed to food from birth to death. Plant protection products are often used on food crops, biocides in food factories, or animal housing. Therefore, tests are required to determine the risk of pesticide residues in the raw agricultural commodity (RAC) and the processed food products. 

Board for the Authorisation of Plant Protection Products and Biocides, Ctgb... 

The Biocidal Products Directive strongly regulates biocidal products before they are placed on the market in a similar way to plant protection products. The basis of the decision by the authorities is the evaluation of all risks for man, animals and the environment arising from the use of a biocidal product and the assessment of whether... 

The TGD makes note of the possibility that the above substances may be used only in plant protection and biocidal products, in which case they would be considered to be registered under REACH (Article 12a). There is no EC number for either of the two substances, or for the mixture, and neither of the substances is found on the publicly accessible TSCA Inventory. This is probably because they are used as plant protection and biocidal products which are not present on either EINECS or the TSCA Inventory. 

Little is known about the adaptive functions of iodine in kelps and other marine plants or the mechanism involved in its concentration (Colin et ai, 2003). Iodine may play a role in the production of volatile hydrocarbons, thus creating defense metabolites that scavenge activated oxygen species and biocides (Ohsawa et ai, 2001 Wever et ai, 1991 Pedersen et ai, 1996). Algae may also concentrate iodine to protect themselves from protozoans and bacteria (Hartmann, 1990). 

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