Inventory of biocides used in Denmark 3. Main group 1: Disinfectants and general biocidal products
These product-types exclude cleaning products that are not intended to have a biocidal effect, such as washing preparations, powders and similar products. Producers and suppliers of products for disinfection in Denmark are organised in the trade organisation SPT (Trade Organisation for Soap, Perfume and Toiletries). As part of this project SPT has carried out an inventory of disinfectants in products traded on the Danish market by the members of the organisation. The following chapter is to a large extent based on the results of this inventory. As the members of the trade organisation do not cover 100% of the market, additional information has been gathered from other suppliers, or the total consumption in Denmark is estimated by extrapolation of the SPT inventory results. It has been attempted to base the estimates of the total consumption on extrapolations of the SPT inventory. The lists of used active agents in the following sections are mainly based on the SPT inventory, and the lists are most likely not comprehensive. The information on the consumption of specific compounds is in the publishedreport only indicated for agents for which the consumption volumes is based on information from more than two suppliers. The confidential version of this report contains in addition a list of substances registered in PROBAS as used as disinfectants. 3.1 Product-type 1: Human hygiene biocidal productsProducts in this group are biocidal products used for human hygiene purposes. Human hygiene biocidal products are mainly used in relation to care, examination and treatment of patients in the public health service sector, in private medical and dental clinics, nursing homes, in the food processing industry and other food handling areas. A limited number of products are used in private homes and workplaces with the purpose of avoiding contamination and preventing infections in relation to cuts, abrasions and the like. Human biocidal products have until now not been covered by any statutory approval procedure. The product-type includes only one sub-type:
Biocides in cosmetic products and products specifically intended for medicinal purposes are not covered by the Biocide Directive and are consequently excluded from this assessment. Antibacterial soaps were at first left out of the assessment, as they were not considered to be biocidal products, but were later included as a result of the borderline discussions and also in order to cover triclosan-containing soaps. When the identified suppliers were approached in relation to this project, the understanding was, in accordance with the available borderline documents from the Commission, that human hygiene biocidal products covered by the directive were products mainly intended for application on intact skin or for general hygiene purposes, which are not defined as 'medicinal' use. At a later meeting in a working group discussing the borderline with other legislation, it was decided to replace this border by a border based on the purpose and the use of the products instead. This was because it appeared impossible to draw a line on the basis of intact/wounded skin only. Medicinal use in relation to disinfectants also still needs to be clarified. A written proposal from the Commission defining the borderline was planned to be distributed to the contact points and the medicinal authorities in the Member States. The main problem with regard to the borderline between the Medicinal Products Directive (65/65/EEC as last amended by Directive 93/93/EEC) and the Biocides Directive is that the medicinal authorities have a different understanding of what is covered by the Medicinal products Directive. Products for treatment of acne and shampoos to control dandruff are considered to be cosmetic products covered by the Cosmetics Directive (76/768/EEC) or in special cases to be medicinal products and covered by the Medicinal Products Directive, when a therapeutic claim is made. Suntan products containing antimicrobial ingredients, antiperspirants, deodorants, and mouth and denture products are considered to be cosmetic products. This demarcation is based on the current discussions in the available borderline documents from the Commission and may change in the future. Some of the products excluded on this basis are included in other projects identifying biocidal products in use in different European countries. 3.1.1 Skin disinfectantsSkin disinfectants or antiseptics are used for human hygiene purposes in order to destroy microorganisms that could cause infections or have a detrimental effect on human activities, for example spoiling or contaminating food or for general hygiene purposes in the health care sector. Skin disinfectants either inhibit the growth (microbiostatic effect) or kill microorganisms (microbiocidal effect) on the surface of the skin. Disinfectants specifically aimed at treating or preventing disease in human beings and animals are regarded as medicinal products. Chlorhexidine is one of the most common active ingredients used in human hygiene disinfectants for retail sale and also to a large extent for use in the health care sector. The absence of a Danish approval procedure for chemical disinfectants has resulted in a large number of different products on the market, many of them containing similar ingredients. Skin disinfectants particularly used in the health care sector are generally containing chlorhexidine, iodine or alcohols as active ingredients according to information from Statens Serum Institut (Statens Serum Institut, 1997). Triclosan is found in many antibacterial soap-formulations for both the professional and the private market. If the concentration is less than 0.3%, triclosan will act as a preservative, and the statutory order on cosmetics will apply. In order to achieve a biocidal effect the concentration must be above this limit. Chlorhexidine is rapidly bactericidal and persistent and is recommended as a relatively non-toxic skin antiseptic for general use. It is most active against Gram-positive organisms and fairly effective against Gram-negative bacteria and many viruses. It is inactivated by soap and organic matter and is therefore used in aqueous or alcoholic solutions for topical application, hand and skin washing. Chlorohexidine and alcohol are often used together for skin disinfection. Iodine is mostly used in solutions with water and detergents (iodophors) together with alcohol. Iodine complexes with the detergents and exists in equilibrium with a small amount in the water phase. Iodophors are slowly sporicidal but rapidly effective against vegetative organisms including fungi and Trichomonas. The microbiocidal effect, especially against viruses, is however varying. Iodine in alcohol solutions (tincture of iodine) are powerful and efficient skin disinfectants, but also rather irritant to skin. Free iodine may cause toxic dermatitis and is easily absorbed through injured skin. Previously these tinctures were widely used. Alcohols like isopropyl alcohol and ethanol are optimally bacteriocidal in aqueous solution at concentrations of 70 to 75%, and have very little bacteriocidal effect outside this range, e.g. when 'absolute' or diluted too much. Alcohols represent the group of substances which most rapidly and efficiently reduces the number of microorganisms on the skin. They are microbiocidal against bacteria including mycobacteria, fungi and especially lipid containing virus. They are not active against spores and non-lipid containing viruses. Triclosan has been widely used as an antimicrobial agent in consumer goods including cosmetics for many years. Recently it was discovered that triclosan has a very specific mode of action, as is the case for antibiotics. Triclosan is fat-soluble and crosses easily cell-membranes. Once inside the cell, triclosan blocks the active site of an enzyme called enoyl-acyl carrier-protein reductase, preventing the bacteria from producing fatty acids needed for building cell membranes and other vital functions. As a preservative in soaps, triclosan is added in low concentrations (<0.3%). In order to obtain an antiseptic effect, the concentration must typically be up to 3%. 3.1.1.1 Actors on the market The Danish main suppliers or wholesalers of disinfectants to the pharmacies are Nomeco which is the largest, K.V. Tjellesen A/S and the joint-stock company Max Jenne which is the main supplier in Jutland. Among suppliers to the wholesalers are Medicteam, ScanMedic and Unichem in Denmark and Galderma in Sweden. In addition, there is a number of smaller and larger companies supplying disinfectants to the health care sector. A number of these companies has registered their products by Statens Serum Institut (SSI). This registration is voluntary and is not to be mistaken for an approval process. A product, which is registered by SSI, will however more easily be introduced in the hospital and health care sector. The names of these companies and their products appear in a booklet on disinfection in the health care sector published by SSI (Statens Serum Institut, 1997). The main suppliers for the professional market are Henkel Ecolab A/S, Novadan A/S and Diversey Lever A/S and the main suppliers to the retail market are Matas A/S, the pharmacies and to a lesser extent supermarkets and department stores. 3.1.1.2 Biocides used in Denmark for the application area According to information from major Danish hospitals, Statens Seruminstitut and SPT, the most frequently used biocides for skin disinfection are those listed in Table 3.1. Table 3.1
3.1.1.3 Consumption of biocides with finished products Skin disinfectants are used in the primary health care sector, the hospital sector, in industry and institutions and in private homes. According to the Danish Medicines Agency it is not possible to get the full picture of the use of skin disinfectants in the primary health care sector and the hospital sector from the Medicinal Products Statistics in 1998. This statistics includes data submitted by high street (private) pharmacies, hospital pharmacies and Statens Seruminstitut. As of 1 July 1995, it became compulsory for pharmacies to install a special point-of-sale terminal to enable recording of over-the-counter (OTC) sales. Based on this recording the sales of chlorhexidine in 1998 in the primary health care sector amounts to DKK 1,600,000 (pharmacy retail price) and DKK 220,000 in the hospital sector (settling price). Information from the County Medicine Registration Office in Denmark, which is an office belonging to the Association of County Councils in Denmark, provides an overview of the consumption of SAD (Sygehusapotekerne i Danmark) skin disinfectants in the hospital sector in 1999. The County Medicine Registration Office in Denmark is responsible for registration of SAD-medicines in the Danish Medicines Agency's speciality register and for maintenance of the documentation for medicinal products produced by the hospital pharmacies in Denmark. Apart from the SAD products, which are produced by the hospital pharmacies, the hospitals also purchase skin disinfectants from wholesalers and other companies supplying products to the health care sector. SAD products are estimated to account for only a small fraction of the consumption in the hospital sector according to some of the hospital pharmacies. Information about the consumption of skin disinfectants in the hospital sector in Copenhagen County was therefore obtained in order to estimate the total consumption of skin disinfectants in this sector in Denmark. Using the number of inhabitants in Copenhagen County and in Denmark, the total consumption of skin disinfectants in Denmark is estimated to be approximately eight times the consumption in Copenhagen County. The same extrapolation is used in relation to the consumption of medicinal products in general (L. Nielsen, 2000). In order to include also the primary health care sector, the amount of skin disinfectants used in Copenhagen County is estimated at 5-10% of the total consumption. In Table 3.2 the consumption of chlorhexidine, surgical spirit and iodine in the health care sector and triclosan in antibacterial soaps is shown. The table does not provide a full picture of the consumption of skin disinfectants in Denmark, as the private sector is only partly included. Due to a change in the demarcation between the Medicinal Products Directive, the Cosmetics Directive and the Biocides Directive, it has not been possible to provide a full overview within the timeframe of the project. Table 3.2
3.2 Product-type 2: Private area and public health area disinfectants and other biocidal productsThe product-type is organised into the following sub-types: 3.2.1 Disinfectants for private areasDisinfectants for private areas primarily include chlorine containing products for bleaching, surface disinfection and automatic dishwashing and furthermore disinfectants for toilets. Information about the active ingredients and the consumption of biocidal products was obtained from the trade organisation SPT, based on both available information about the sodium hypochlorite consumption in Denmark a few years ago and responses to questionnaires sent out by SPT to their members specifically in relation to this project. SPT estimates that their members cover 80-90% of the market for disinfection in Denmark. As disinfectants for private use do not have to be registered with the Danish Product Register, no relevant information is available from PROBAS. 3.2.1.1 Actors on the market The main suppliers of disinfectants for private areas are Reckitt Benckiser A/S, A/S Blumøller, Colgate Palmolive and Lever Fabergé Danmark A/S. Only A/S Blumøller and Colgate Palmolive have production in Denmark. One of the larger supermarkets in Denmark markets disinfectants for toilets under their own branding. Their supplier, Nopa, is not a member of SPT, and the consumption of their products is not included in the assessment. 3.2.1.2 Biocides used in Denmark for the application area The identified biocides used for toilet disinfection and other private household disinfection are shown in Table 3.3. The total number of different products for toilet disinfection included in the assessment is about 12. Table 3.3
The consumption of biocidal active agents with these product groups - based on the information from SPT - is shown in Table 3.3. Main agents for the application area are sodium hypochlorite, phosphoric and sulfamic acid. Table 3.4
3.2.2 Disinfectants for professional cleaning and industrial useProfessional and industrial use in this context includes industry, institutions, the primary health care sector and the hospital sector. The primary health care sector is here defined as general practitioners (medical and dental clinics), nursing homes and similar institutions. Disinfectants for professional and industrial use include products for disinfecting surfaces like floors and walls as well as larger pieces of portable equipment and furniture. Disinfectants for food handling areas are not included, as they are covered by product-type 4. The efficiency of the disinfectant depends on the direct contact between the disinfectant and the surface that need to be disinfected, the concentration of the active ingredient, duration of the contact and on the pH and the temperature of the solution. As most disinfectants act by denaturing or altering proteins or lipids in the cytoplasmic membrane, they will need time to penetrate the outer surface of the microorganisms. The time it takes to kill a certain microorganism depends on the specific biocide. 3.2.2.1 Actors on the market The main suppliers of biocidal products in Denmark for professionel and industrial use are Henkel Ecolab A/S, Novadan A/S and Diversey Lever A/S. Suppliers to the primary health care and hospital sector are wholesalers of disinfectants to the pharmacies including Nomeco, K.V. Tjellesen A/S and the joint-stock company Max Jenne. Among suppliers to the wholesalers are Medicteam, ScanMedic and Unichem in Denmark and Galderma in Sweden. 3.2.2.2 Biocides used in Denmark for the application area In Denmark, there has been no legal demand for approval of chemical disinfectants for professional and industrial use as defined here. This has resulted in quite a considerable number of different products on the market. Many of these are variations of the same basic constituents. Disinfectants for professional use which are defined as hazardous according to Statutory Order no. 540 on substances and materials from the Danish Working Environment Authority must be notified with the Product Register. For disinfection of surfaces, the main active ingredients include chlorinated compounds, acids and quaternary ammonium compounds. Quaternary ammonium compounds are not always considered real disinfectants as soap and organic material easily inactivate them, and because they are not very effective against gram-negative bacteria like Pseudomonas. They are also not very efficient against virus. They do however have very god surface active properties and are therefore often used as auxiliary substance in disinfectants with the purpose of dissolving dirt. Contact to some of the major hospitals in Denmark confirmed that very few chemical disinfectants are used for cleaning of surfaces. In the Hygiene principles for the hospitals in Copenhagen County, it is stated that surfaces should be cleaned with surgical spirits (70% v/v). Mixtures of surgical spirits and chlorhexidine are also used for some cleaning tasks, especially for portable equipment. Products based on buffered and stabilised peracid are used only in extreme cases, e.g. when the operating room is heavily contaminated. Table 3.5
The total consumption of disinfectants for the professional and industrial area is estimated at 710-1,140 tonnes based on an assessment carried out by the trade organisation SPT. This estimate is based on answers to questionnaires sent out to all members of the trade organisation, who are expected to cover about 80% of the market. It should be noted that surgical spirit, which is widely used for mild disinfection in the health care and hospital sector, is not mentioned in the list of biocides. This is probably because surgical spirits are supplied by companies which are not members of SPT. According to information from the hospitals in Copenhagen County, the consumption of surgical spirit in 1998 at these hospitals was 17,500 l (14 tonnes) in 1998. Assuming this amount corresponds to 5-10% of the consumption in the health care sector as a whole, the total consumption of finished product would be 140-280 tonnes. This assumption is based on the same principles for extrapolation as was used for the skin disinfectants. In PROBAS, there are 64 different active ingredients registered as disinfectants in the products. Of these 64 active ingredients, 13 are also included in Table 3.1. Two products for toilet disinfection containing sodium hypochlorite are registered in PROBAS and 23 products in total for toilet cleaning. Table 3.6
3.2.3 Disinfectants for medical equipmentMultipurpose disinfectants or sterilisation agents are covered by this product group. Disinfectants specifically intended for use with medical devices (e.g. contact lens care products for disinfecting) fall under the definition accessory and are covered by the Medical Devices Directive (93/42/EEC) according to a document from the European Commission, DGIII (The European Commission, March 1998). The document determines the demarcation between Medical Devices Directives and Medicinal Products Directives. These disinfectants are used to enable the device to be used in accordance with its intended purpose or to enhance the performance of the device. This demarcation may however also be changed, so that this type of products will be covered by the Biocides Directive in the furture. The method for sterilisation, which means that the medical equipment is freed from all living organisms, including viruses, bacteria and their spores and fungi and their spores, both pathogenic and non-pathogenic, is mainly heat. But for disinfecting equipment, which is heat-sensitive, chemical disinfectants are used. 3.2.3.1 Actors on the market Henkel Ecolab A/S, Novadan A/S, Diversey Lever A/S, Johnson and Johnson and Superfos Biosector are among the main suppliers who are also members of SPT. According to the disinfection booklet from Statens Serum Institut, products are also marketed by a number of other suppliers, who are listed in the booklet. 3.2.3.2 Biocides used in Denmark for the application area A typical biocide for chemical disinfection is buffered glutaraldehyde. The efficiency of glutaraldehyde solutions is highly dependent on the correct pH, and they are therefore supplied together with a separate alkaline buffer, which is added before use. The efficiency increases with increasing pH, which at the same time decreases the stability of the disinfectant. A number of biocides for this application area is listed in the booklet from Statens Seruminstitut giving advice and instructions about disinfection in the health care sector. These suggestions include hypochlorite, chlorine dioxide, chloramine and dichloro isocyanurate. A consumption of these has not been revealed by the assessment carried out by SPT. Contact to some of the major hospitals in Denmark confirmed that very few chemical disinfectants are used for medical equipment. In the Hygiene principles for the hospitals in Copenhagen County, it is stated that heat should be used whenever possible. Glutaraldehyde in a concentration of 2% is used for flexible endoscopes, and heat-sensitive equipment is soaked 60 minutes in a solution containing chlorine and potassium bromide. A typical biocide for chemical disinfection is buffered glutaraldehyde. The efficiency of glutaraldehyde solutions is highly dependent on the correct pH, and they are therefore supplied together with a separate alkaline buffer, which is added before use. The efficiency increases with increasing pH, which at the same time decreases the stability of the disinfectant. Glutaraldehyde is not significantly inactivated by organic material and is active against spores. Aldehydes, including glutaraldehyde, are among the more toxic disinfectants and gluteraldehyde is both irritant and sensitising. Table 3.7
Table 3.8
3.2.4 Disinfectants for laundriesLaundry disinfectants can be used for laundry from the primary and secondary health care sector, hotels, nursing homes and other areas where disinfection is needed. Typical biocides for this application area are chlorine, hypochlorite, peroxide and peracetic acid. The disinfectants which are used have a combined effect as both disinfectants and bleaching agents. 3.2.4.1 Actors on the market Main suppliers of bleaching agents and disinfectants are Henkel Ecolab A/S, Diversey Lever A/S and Novadan A/S (Larsen et al., 1998). 3.2.4.2 Biocides used in Denmark for the application area Table 3.9
Estimates of the consumption from Larsen, 1998, is shown in Table 3.1. The total consumption is estimated at 277 tonnes. Table 3.10
3.2.5 Disinfectants for air-conditioning systemDisinfectants can be applied to air-conditioning systems with the purpose of preserving the cooling liquid or disinfecting the system. Contamination of the cooling liquid is most likely to happen in open or semi-open systems, e.g. for control of Legionella and other pathogenic bacteria in cooling water in hospitals. Contact to suppliers of cooling liquids showed that biocides used for liquid-cooling and processing systems and biocides for air-conditioning systems were very much the same. In this report, the biocides used for air-conditioning systems are therefore included in the description of product-type 11, preservatives for liquid-cooling and processing systems. 3.2.6 Disinfectants for chemical toiletsDisinfectants for chemical toilets are added with the purpose of cleaning and controlling possible growth of bacteria. Chemical toilets are typically mobile and mostly found in boats, busses and campers with no connection to the sewer system. 3.2.6.1 Actors on the market Main importers and suppliers of biocides for chemical toilets in Denmark are Camper and DCT, both located in Jutland. Camper markets Thetford products and DCT markets Italian products. Neither of these companies are members of the trade-organisation SPT. Among the SPT members only one company is registered. 3.2.6.2 Biocides used in Denmark for the application area A large number of biocides for toilet cleaning and disinfection is registered in the Product Register. It is however not possible to distinguish between ordinary toilet disinfectants and disinfectants for chemical toilets, but most likely some of the registered products are for chemical toilets. According to a main supplier, who is not a member of SPT, his products only contain biocides as preservation and only in very small amounts (<0.1%). Table 3.1 therefore only contains data from SPT and cannot be considered representative to all biocides for this application area. Table 3.11
According to the assessment carried out by SPT about 15 tonnes biocidal products was used for chemical toilets in 1998. The assessment, however, is estimated only to cover a part of the market, as the main suppliers are not members of the organisation. It has not been possible to obtain detailed information of the rest of the market, and the total consumption will here be roughly estimated on the basis of the following assumptions. According to the Statistics Denmark, the number of registered caravans is around 100,000. Most caravans have a toilet, but not all of the toilets are used regularly. Typically, 150 ml of the biocidal product is used for 20 l of water. Based on the experience of a few interviewed campers, it is assumed that on average 0.3-1.5 litres of biocidal product are used per caravan per year. The total consumption will based on these assumptions be approximately 30-150 tonnes. Quaternary ammonium compounds seem to be the biocides of choice in concentrations around 10%. Table 3.12
3.2.7 Disinfectants for swimming poolsThe quality of water in swimming pools is regulated through the Statutory Order No. 195 of 5 April 1998 that is under revision. This order covers swimming pools, which are intended to be used by a larger number of people, e.g. in schools, hotels, camping grounds, holiday camps, etc. In order to ensure a low level of microbes and thereby protect the bathers from getting sick, swimming pool water is disinfected with chlorine gas or hypochlorite. Sodium hypochlorite is the main disinfectant for this application area, whereas calcium hypochlorite and chlorine gas are only used in smaller amounts and not very often. 3.2.7.1 Actors on the market Main suppliers of sodium hypochlorite for swimming pools include Henkel Ecolab A/S, Novadan A/S, and Diversey Lever A/S. 3.2.7.2 Biocides used in Denmark for the application area Table 3.13
In 1981 the consumption of disinfectants for swimming pools was estimated in a report from the Danish Environmental Protection Agency /Bidsted et al, 1981/. At that time, the consumption of sodium hypochlorite was estimated at 3,250 tonnes, the consumption of chlorine gas at 5 tonnes and the consumption of calcium hypochlorite at 13 tonnes. Since 1981 the number of swimming pools has increased but the consumption of disinfectants has decreased at the same time. According to the Danish Techological Instute, Swimming Pool Technology /Ole Bidsted, 2000/ it must be expected that the consumption of sodium hypochlorite in 1998 should be lower than in 1981. Based on an assessment made by SPT a few years ago, the consumption of sodium hypochlorite for swimming pools is estimated at 500-1,000 tonnes (Table 3.1). Table 3.14
3.2.8 Disinfectants for wastewater and hospital wasteFive major hospitals in Denmark, including the hospitals in Copenhagen County, have been asked about the use of disinfectants for waste and wastewater. None of the hospitals used disinfectants for this purpose, and it is assumed that this is the general picture all over the country. There are no longer any approved products for soil disinfection on the Danish market according to the Danish Plant Protection Association. Based on this information, the total consumption for these application areas is estimated to be zero. 3.3 Product-type 3: Veterinary hygiene biocidal productsVeterinary hygiene biocidal products are biocidal products used for veterinary hygiene purposes including products used in areas in which animals are housed, kept or transported. The product-type can be subdivided into the following sub-types:
Biocidal products used for cleaning of teats and udder, for animals' footbaths, for disinfection of equipment for feeding and feed areas as well as products for disinfection of milking equipment are included in this section. The estimates of consumption in this section include entries in the inventory from SPT, which could be positively correlated to use for veterinary purposes, i.e. entries like udder cleaning, animal stables and milking machines. Entries in the inventory, which are described solely by wording like cleaning, disinfection, surfaces, equipment, tubing or containers, are included in section 3.2. 3.3.1 Disinfectants applied directly to domestic animalsDisinfectants applied directly to domestic animals are used for the control or prevention of diseases, for cleaning the animals feet and for udder cleaning. The substances used for disease control or prevention are covered by the Veterinary Medicinal Products Directive (81/851/EEC as last amended by Directive 93/40/EEC). Products used to kill and/or repel arthropods are included in Main Group 3: Pest Control, product-type 18. Disinfectants in products for cleaning the animals feet are considered biocides. Products used for teats and udder cleaning are considered biocides in the EU regulation (EU Biocidal Group, 1999). In Denmark, these products are covered by the Veterinary and Food legislation, but results regarding their use are included in Table 3.1 and Table 3.1. For stocks of cattle, pigs and sheep, in which infectious skin diseases are a problem (e.g. digital dermatitis), disinfectants may be used in hoof baths, which the animals are forced to walk through regularly, e.g. on their way to the stable in which the milking takes place. According to the Danish advisory service for cattle (Landskontoret for Kvæg), the main use of disinfectants for cleaning the animals feet takes place in cattle farms and is at present increasing due to an increase in the problems. Disinfectants for teats and udder are used before milking and for teats after milking. The products may be applied by means of cloths, by dipping or as sprays. 3.3.1.1 Actors on the market Two Danish suppliers of products for disinfection of animals feet have been identified: Vittfoss and Danish Genetics. The main suppliers of agricultural chemicals in general are not marketing products, specifically for hoof baths, but they state that some of the products sold for general disinfection in stables are also used for this purpose. The amounts should thus be included in section 3.3.2. Danish producers and suppliers of disinfecting products for cleaning of teats and udder are Alfa Laval Agri, Ciba Geigy A/S, DiverseyLever, Medimerc A/S, Novadan A/S, Henkel-Ecolab A/S, Hypred Danmark A/S, Superfos Biosector A/S, B.S. ApS, S.A. Christensen, Danish Genetics A/S, J.P. Hansen Ltd., Jettadam Fabrikker A/S, Linds Handelsselskab, Manus Agroteknik, MW-cleantrade ApS, Nardos og S. Sørensen. Among these, Alfa Laval Agri, DiverseyLever, Novadan A/S and Henkel-Ecolab A/S are the dominating suppliers. 3.3.1.2 Biocides used in Denmark for application directly to domestic animals for disinfecting the animals feet and for udder and teats Biocides used for the application area are shown in Table 3.1. The list is based on the inventory of SPT supplemented by additional information (CuSO4, chlorhexidine-digluconate and isopropanol) The disinfectants used for hoofs are formaldehyde and CuSO4. Due to the strong irritant and carcinogenic properties of formaldehyde, products containing this substance are not recommended by the advisory service. No information is available regarding the use of this substance for this purpose. Possible use of formaldehyde for hoof baths may be included in the consumption for stables, i.e. in section 3.2.2. According to the advisory service, the consumption of products for hoof baths is very limited, and it is not included in the consumption volumes below. One of the biocides used for udder and teats cleaning is dodecylbenzene sulfonic acid (LAS). However, even if LAS is included in the EU-list of biocides for type 3 products, its classification as a biocide may be questioned, as it is mainly used as a detergent. Sodium dichloroisocyanurat, which is frequently used for the cleaning of teats, is not mentioned for this use in the SPT-inventory. However, it is included under the heading milking equipment, and the use for cleaning of teats is supposedly covered by the consumption described in section 3.3.3. Table 3.15
The total consumption of biocides for cleaning udder and teats in Denmark is estimated to be 19-22 tonnes per year (Table 3.1) Table 3.16
3.3.2 Disinfectants for areas in which animals are housed, kept or transportedAreas in which animals are housed, kept and transported are most often cleaned and disinfected on a regular basis in order to prevent the build up and/or dispersal of pests and/or diseases among the animals. Disinfectants for areas in which animals are housed are used for disinfection of the entire stable, including disinfection of containers, consumption utensils, surfaces and pipe work for transport, storage and consumption of feed and drinking water. Such disinfection may be carried out, when a section of a stable is closed down, e.g. every 6 weeks by slaughtering of chickens, in case of heavy infections with e.g. salmonella, or occasionally after emptying the stables. Normally, a disinfection process is very extensive and comprises the whole interior of the building, including all equipment. Furthermore, disinfectants may be used for the footwear of people working in the stables in the form of containers in which the footwear is cleaned before entering into the stables. According to the Danish advisory service, this practise is limited in Denmark, and the consumption is not included in the assessment. The number of disinfectants used in pig and cattle farming is limited, as most cleaning is based on the use of high-pressure water and lime. 3.3.2.1 Actors on the market The principal Danish producers and suppliers are Alfa Laval Agri, DiverseyLever, Novadan A/S and Henkel-Ecolab A/S. 3.3.2.2 Biocides used in Denmark for application in areas in which animals are housed, kept or transported including feed areas Disinfectants used for cleaning areas in which animals are housed, kept and transported are shown in table 3.17. Table 3.17
The total consumption of biocides for areas in which animals are housed, kept or transported in Denmark amounts to 4-5 tonnes per year, of which formaldehyde, glutaraldehyde and hydrogen peroxide are the dominant, sold in amounts of one tonne per year of each. Sodium dichloroisocyanurate is not mentioned for this use in the inventory of SPT, but the use for disinfection in stables is expected to be covered by the consumption volumes in section 3.3.1. Table 3.18
3.3.3 Disinfectants for milking equipmentDisinfectants for milking equipment may be covered by Directive 92/46/EEC (production and placing on the market of milk). However, as the products used for this purpose are used in the same production process as the remaining veterinary products, the available data on the use of disinfectants for milking equipment are presented here. Disinfection of milking equipment includes the milking machines, pipework and containers used for the milk. Typically, these are disinfected after each batch of milk by flushing the system with the disinfectant followed by clean water to remove possible residues of the product. 3.3.3.1Actors on the market The Danish market for agricultural, biocidal products is dominated by four producers and suppliers: Alfa Laval Agri, DiverseyLever, Novadan A/S and Henkel-Ecolab A/S. 3.3.3.2 Biocides used in Denmark for the application area milking equipment The use of disinfectants for milking equipment is dominated by chloride and acid compounds. Table 3.19
The total, annual consumption of disinfectants for milking equipment in Denmark is estimated to be 71-83 tonnes of which the chloride compounds account for 25-30 tonnes and the acid compounds for 43-51 tonnes. Table 3.20
3.4 Product-type 4: Food and feed area disinfectantsFood and feed area disinfectants are used for disinfection of equipment, containers, consumption utensils, surfaces or pipe work associated with production, transport, storage or consumption of food, feed or drink (including drinking water) for humans and animals. The product-type can be organised into the following application areas:
Food and feed area disinfectants are used to secure a high standard of hygiene in order to interrupt potential sources of infection and contamination of food and feed, and thereby minimising the risk of foodborne diseases. 3.4.1 Food and feed area disinfectants used in agricultureDisinfectants are used in agriculture for disinfection of containers, consumption utensils, surfaces and pipe work for transport, storage and consumption of feed and drinking water. Feed area disinfectants are not used on a routine basis. Disinfection may be carried out when a section of a stable is closed down, e.g. every 6 weeks by chicken slaughtering, in case of heavy infections with e.g. salmonella, or occasionally after emptying the equipment. The feed system will not be disinfected separately. In practice, a disinfection process is very extensive and comprises the complete interior of the building including all equipment. Disinfection of the feed system is therefore integrated in the disinfection process for veterinarian hygiene purposes. It is not possible to estimate the biocide consumption specifically with regard to disinfection of feed systems. The biocides used for this application are the same as used for veterinarian hygiene purposes. According to the industry, the consumption is included in the figures for veterinarian hygiene purposes (in section 3.3). Under certain circumstances, e.g. by private well-borings with varying water quality, or when drinking water is stored in open systems, biocides are used for disinfection of drinking water. In these cases, disinfectants approved for the food industry are used. According to the industry, the consumption for this application is included in the figures for the food-processing industry (section 3.4.2.). 3.4.2 Disinfectants used in the food-processing industryDisinfectants intended for use in the food-processing industry are mainly defined or within the scope of other directives e.g. 89/109/EEC (materials and articles intended to come into contact with foodstuffs), 92/46/EEC (production and placing on the market of milk), 89/437/EEC (production and placing on the market of egg products), 89/1107/EEC, 88/388/EEC and 95/2EC (food additives and flavourings), 91/493/EEC (production and placing on the market of fishery products), 95/5/EC (production and marketing of certain products of animal origin). This means that products comprised by these directives are excluded from the Biocide Directive. The Biocide Directive applies to products intended for hand disinfection. The Biocide Directive also applies to products intended for disinfection in food retail shops and other food handling areas, e.g. cafeterias and canteens. In Denmark, the national legislation does not discriminate between disinfectants used in the food-processing industry or in retail shops and other food handling areas. This means that all disinfectants, which may come into contact with foodstuffs, must be approved by the Danish Veterinary and Food Administration. The suppliers do not categorise the consumption of disinfectants, and in the light of this, it is not possible to estimate the consumption exclusively for the retail area and other food handling areas. The estimate of consumption covers disinfectants used for the whole food handling area in Denmark. Disinfectants are typically used after clean-up processes for disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or beverages. After application of the disinfectant, the treated area/equipment is washed with water. 3.4.2.1 Actors on the market The Danish main producers of disinfectants or the food industry are Henkel-Ecolab and Novadan, and the main suppliers are Henkel-Ecolab, Diversey-Lever, Novadan, SFK a.m.b.a. and Nopa-Nordisk Parfumerivarefabrik A/S. Producers and suppliers of disinfectants for foodstuffs are organised in the trade organisation SPT (Soap, Perfume and Toiletware). 3.4.2.2 Biocides used in Denmark for the application area All disinfectants, which may come into contact with foodstuffs, must be approved by the Danish Veterinary and Food Administration. The identity of active biocidal compounds is therefore well known. The approval is based on the concept that residues do not cause acute or chronically harmful effects to the consumer. Furthermore, in order to secure that food will not be contaminated by biocides, all disinfected equipment must be washed with water before use. A list of approved active ingredients in disinfectants (of 9 October 1998) is shown in the table. Table 3.21
1) List of approved active ingredients in disinfectants for the food area, 9 October 1998 Approximately 200 biocides are registered as disinfectants in PROBAS. The application areas are not indicated, and consequently it is not possible to pick out those intended for the food and feed area. According to the industry, only a limited number of the biocides accounts for the main part of the consumption for food area disinfection. Chlorine in the form of liquid Sodium hypochlorite is the most well-known and used disinfectant in the food industry. Sodium hypochlorite causes irreversible oxidative attacks on the cells in microorganisms. A powdered organic chlorine-releasing compound like sodium dichloroisocyanurate is used in small amounts. Chlorine itself is very sensitive to organic material and will suddenly be reduced by dirt leading to ineffectiveness. Hydrogen peroxide and peracetic acid are oxidising disinfectants like chlorine. Quaternary ammonium compounds (benzalkonium chloride and didecyl dimethyl ammonium chloride) are surfactants that disturb the permeability of the cell membrane resulting in cell death. Table 3.22
3.4.2.3 Consumption of biocides with finished products The total consumption of disinfectants for the food handling area is shown in Table 3.1 based on an inventory carried out by the trade organisation SPT. This estimate is subject to some uncertainty, because the figures do not include the total consumption of disinfectants used in other food handling areas than the food-processing industry. Some companies have divisions for the industrial market and the retail market. The consumption of disinfectants for other food handling areas, e.g. cafeterias and canteens will often be regarded as a part of the retail market, and as such reported under product-type 2: Private area and public health area disinfectants and other biocidal products. Table 3.23
3.4.3 Disinfectants used for food handling in retail shops or other food handling areasDisinfectant are used for food handling areas other than the food-processing industry, e.g. retail shops as butchers, bakeries, cafeterias, canteens and other catering activities to secure a satisfactory hygienic standard. As mentioned in section 3.4.2, the biocides for these application areas must be approved in Denmark by the authorities. In the light of this, the suppliers do not split the consumption of biocides for the food-processing industry and other food handling areas. The consumption for other food handling areas than the food-processing industry is included in the figures shown in section 3.4.2 and in some cases reported under product-type 2: Private area and public health area disinfectants and other biocidal products. The estimate of the consumption is subject to some uncertainty, because disinfectants intended for other applications, e.g. private cleaning, may be used professionally for disinfection in food handling areas. Disinfectants are typically used after clean-up processes for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with production, transport, storage or consumption of food or beverages in food handling retail shops or other food handling areas, e.g. cafeterias and canteens. After application of the disinfectant, the treated area/equipment is washed with water. Actors of the market will also be covered by the description in section 1.2.2. 3.5 Product-type 5: Drinking water disinfectantsDrinking water disinfectants are primarily used for the disinfection of drinking water at the waterworks. The product-type includes disinfectants used by the waterworks and disinfectants used locally by the user before drinking low quality water. Drinking water disinfectants are used at the waterworks to control the microbiological quality of the water before it is supplied to the distribution network. The intention is to destroy pathogenic and infectious micro-organisms and to reduce the total counts of micro-organisms to an acceptable level. Disinfectants for cleaning of the drinking water distribution network are used only occasionally when laying down new drinking water mains, and only if flushing with drinking water is not sufficient to secure low content of germs. Drinking water disinfectants can be used locally for disinfection of drinking water in case of bad sanitary conditions, e.g. during travelling and temporary stays in developing countries. These products are not used in Denmark. 3.5.1.1 Actors on the market Chlorine for disinfection of drinking water at the waterworks is supplied by common suppliers of industrial chemical compounds. The chlorine is also used as ingredient for site production of monochloroamine disinfectants by the waterworks themselves. 3.5.1.2 Biocides used in Denmark for the application area Harmful microorganisms are not allowed in water for human consumption. The content of total microorganisms, measured as total count at 22 and 37°C, must be below 50 and 5 per ml, respectively. In Denmark, it is not the drinking water policy to add disinfectants except in areas where ground water of good bacteriological quality cannot be achieved, or in areas where surface water is used for drinking water. Addition of disinfectants to drinking water can only be carried out at a waterworks, if the Regional County finds it acceptable and intends to approve the disinfection product according to the § 21 in the Water Supply Act. Normally, the Danish EPA is asked to carry out an assessment of the disinfection product and to set up purity criteria for the product. Until now, only chlorine products like chlorine and sodium hypochlorite and substances produced from them, e.g. monochloroamine, are used as disinfectants for drinking water. The same disinfectants are used for surface water during the treatment process at present, but ozone has been used in a newly closed plant. Disinfection must be carried out in such a way that formation of disinfection by-products is minimised. Therefore, chlorination is only accepted after the flocculation and sedimentation step of the water treatment process. The biocidal properties are based on the strong oxidizing effect of the chlorine and chlorinated compounds. Disinfection at drinking water supply plants is primarily carried out when drinking water production is based on surface water. Only one of Copenhagens seven waterworks produces water from surface waters and only in short periods of the year - mainly the summer season. The Copenhagen Water Supply uses chlorine as a third step in the surface water treatment process in amounts of approximately 18 mg/l. The fourth step is to remove all residual chlorine. The last step before the water leaves the waterworks is to add monochloroamine in amounts of approximately 0.35 mg monochloro-amine/litre drinking water. Gentofte Water Services has stopped using surface water, but treats the ground water with monochloroamine to secure the biological quality of the water, before it leaves the waterworks. The dosing of 0.20 mg/l results in approximately 0.15 mg monochloroamine/litre drinking water leaving the plant. The waterworks prepare the monochloroamine by adding hypochlorite to an aqueous solution of ammonium sulphate at adequate pH. Some minor waterworks, Christiansø, Skagen and Rørvig treat their drinking water with sodium hypochlorite before supplying water to the pipe system. The resulting concentration of free chlorine for Skagen is below 0.05 mg/litre drinking water and for Christiansø approximately 0.1 mg/litre drinking water. Table 3.24
3.5.1.3 Consumption of biocides with finished products The total consumption of biocides for this application area is based on information from the waterworks. The annual consumption of drinking water disinfectants in 1998 is shown in table Table 3.1. Even though detailed figures from Skagen and Rørvig waterworks are not included, the estimate is assessed to cover 95% of the consumption. The great variation in annual consumption is caused by the fluctuating amount of surface water used for production of drinking water each year. Table 3.25
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