Substance biocidal

Prior to the 1990s phenyhnercuric acetate was the primary bactericide and fungicide in latex and waterborne paints. Because of the increasing concerns of mercury toxicity and the potential for high consumer and occupational exposures to mercury when present in paints, the U.S. Environmental Protection Agency (EPA) induced U.S. manufacturers of PMA and other mercury compounds to withdraw their registrations for use of these substances as biocides in paints (see AIercury). Mercury compounds are used only for very limited, specific purposes, such as the use of phenyhnercuric mXx.2LX.e[55-68-5] as a bactericide in cosmetic eye preparations (see Cosmetics). 

Table 3. Coastal Water Quality Criteria for Toxic Substances Other Than Biocides ...

Quaternary ammonium compounds biocidal activity mechanism, 1, 401 toxicity, 1, 124 Quaternization heterocyclic compounds reviews, 1, 73 ( )-Quebrach amine synthesis, 1, 490 Queen substance synthesis, 1, 439 4, 777 Quercetin occurrence, 3, 878 pentamethyl ether photolysis, 3, 696 photooxidation, 3, 695 Quercetrin hydrolysis, 3, 878 Quinacetol sulfate as fungicide, 2, 514 Quinacridone, 2,9-dimethyl-, 1, 336 Quinacridone pigments, 1, 335-336 Quinacrine... 

Record potential pollutant sources in the building. Note the locations of major sources. Major sources such as large items of equipment can be recorded on the floor plan. Record the names and locations of chemicals or hazardous substances used or stored within the building, such as those that may be contained in cleaning materials, biocides, paints, caulks, and adhesives. Ask your suppliers to provide you with Material Safety Data Sheets. You may be unaware of the potential hazards... 

Many of the standard works include only the word disinfection in their title yet deal with all classes of compounds and with a wide range of apphcatioa It is unrewarding to be too dogmatic about these terms many substances can function in both capacities depending upon their concentration and time of contact. A more general term, biocide, is now widely used to denote a chemical agent that, literally, kills microorganisms. 

The Directive will operate by listing all active substances which can be used in biocidal products in a list (annex I to the Directive) and requiring that only those active substances listed can be used in biocidal products. Member states will then authorise biocidal products to a set of common principles (annex V of the Directive) with a system of mutual recognition of authorisations. 

There will be a long transitional period (the Directive foresees 10 years) before the Regulations come fully into effect. During the transition period existing national rules will contine to apply - that means CoPR will continue until all biocidal active substances have been reviewed under the biocides programme. 

The Directive, and implementing Regulations require that risk assessments are carried out on biocidal active substances and the products containing them. This requires the submission, and in many cases the generation of data and industry has to provide this. 

It does have a number of draw backs. It has poor thermal stability (a property common to most formaldehyde release biocides) and, in some instances, may cause blackening of metalworking fluid concentrates if heated above 50°C for a period of time. Recently, this active ingredient was placed on Annex 1 of the Dangerous Substances Directive having been identified as a potential skin sensitiser. This means that formulations containing efficacious levels of this class of triazine in them would have to be labelled with R43 - may cause sensitisation by skin contact. This is unacceptable to many UK customers. As this material is only bactericidal, it needs to be co-formulated with a fungicide to provide complete protection for a product. 

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. 

The European Union System for the Evaluation of Substances (EUSES) [8] is the software provided by European Chemical Bureau (ECB) to implement the EU Technical Guidance Documents on Risk Assessment for new notified substances, existing substances, and biocides [3]. The development of EUSES 2.1 was commissioned by the European Commission to the National Institute of Public Health and the Environment (RIVM) of the Netherlands. The work was supervised by an EU working group comprised of representatives of the JRC-European Chemicals Bureau, EU Member States, and the European chemical industry. 

Institute for Health and Consumer Protection (2003) Technical Guidance Document on Risk Assessment in support of Commission Directive 93/67/EEC on risk assessment for new notified substances Commission Regulation (EC) No 1488/94 on risk assessment for existing substances Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market... 

The use of biocides is in Europe controlled and regulated by the EU Biocidal Products Directive [15]. Registration of a biocide is expensive and only a few active biocide substances will in the future be available for the leather industry in the EU. The directive will include a list of active substances that are permitted to use by the leather industry (a so-called positive list). Many eco-labels and RSL does already today include restrictions of the use of some biocides. 

Existing chemical substances do not have to be notified. These are defined as those listed on the European Inventory of Existing Chemical Substances (EINECS) (a. 1), a list of approximately 100,000 substances reported as being supplied in the EU during the reporting period of 1 January 1971 to 18 September 1981 (389, 394). Also the DSD does not apply to medicinal products, cosmetic products, wastes, foodstuffs, pesticides, biocides and radioactive substances. 

Substances notified under the DSD (392) are considered as having been registered. Similarly, substances used only as active substances for plant protection products, which are covered by the Plant Protection Products Directive (a. 13), or for biocidal products, which are covered by the Biocidal Products Directive (a. 14) are counted as registered under REACH. 

Biocidal products are necessary for the control of organisms that are harmful to human or animal health and for the control of oiganisms that cause damage to natural or manufactured products. Although they are beneficial they can pose risks to humans, animals and the environment in a variety of ways due to their intrinsic properties and associated use patterns and therefore a comprehensive evaluation of the hazard and the risk and recommendations for safe use of such substances are required. In February... 

The requirements of Directive 98/8/EC (the Biocidal Products Directive) are briefly outlined and the possible effects of the implementation of this Directive on the market for biocides and development of biocides are considered. The general time-frame for the Directive is indicated and a list of the dossier requirements for the common core data set for active substances is included together with a list of the data required to be submitted under section VI on the toxicological profile for man and animals. 4 refs. 

CEFIC has estimated that more than 60% of the 2,000 biocidal active ingredients and of the 20,000 formulated biocidal products containing them currently marketed in the EU may eventually be withdrawn as a result of the implementation of the Biocidal Products Directive. Avecia believes the BPD is likely to restrict new product development and increase the costs of notifying and listing active substances, meaning that research on new actives will be difficult to justify. Avecia Protection Hygiene develops and produces antimicrobials for more than 25 applications in industrial preservation, disinfection, plastics, textiles and personal care, and it continues to develop new products. 

The new Biocidal Products Directive is examined, which closes the gap in European legislation for products such as disinfectants and anti-foulants where there has not, until now, been a Europe-wide standard. The basic goals of the directive are to simplify and harmonise Europe s regulatory framework for biocides, and to remove trade barriers within the EU, and to improve the protection of both human health and the environment. The new directive must be enforced as national legislation in all member countries by 14 May 2000. Details are given of products defined within the directive, and ways in which the directive will be put into practice in the UK are discussed. The implications of the legislation on the industry in terms of time and money spent on testing for each active substance involved are examined. 

Under the BPD, the biocidal substances are evaluated centrally by the EU Commission. The evaluation is based upon a very extensive data package submitted by the biocide substance manufacturer including a risk assessment of the use of the biocide in AF products. The outcome of the evaluation by the Commission is to decide whether the biocide is prone to be included in a positive list, also termed Annex I, or not. 

This directive is concerned with the authorisation and the placing on the market of biocidal products. It attempts to establish a list of active substances that may be used in biocidal products within the EC. In order to assess which substances should be included in the list, a system of registration, authorisation and periodic evaluation is legislated with this Directive. Once approved, active substances will be incorporated into Annex I of the directive. The system of registration is created for active substances, which pose a low riskfor humans, animals and the environment and will be incorporated in Annex lA. In Annex I B so called basic substances such as are listed. For products of higher concern, usually not an active substance, an authorisation system is established, that includes the formulation of dossiers on these products which need to be submitted to the respective national authority. In Annex I B... 

Substances to be evaluated in accordance with the biocide directive as per a comparable process since 2003 are not dealt with here. 

Figure 4. General principle of risk assessment for new substances, existing substances and biocides...

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