Annex 1 - Summary descriptions of product types 1-23

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Annex 1

Summary Description of Product Types 1 - 23

The present appendix provides background information for the assessment of the need for further risk reduction and relevant risk reduction measures.

For each of the 23 products types, the appendix provides a short overview of:

? Application areas; ? Substances under the product type; ? Data on production/consumption; ? Risks to humans; ? Risks to the environment; ? Assessment of need for risk reduction; ? Relevant risk reduction measures.

The description of the applications and the human and environmental exposures is - unless otherwise indicated - extracted from an assessment of the use of biocides in Denmark (Lassen et al. 2001) and an unpublished exposure assessment undertaken as part of the same study for the Danish EPA (COWI/CETOX 2001).

The description is supplemented with information obtained from a number of Emission Scenario Documents developed mainly in the context of the EU EUBEES I and II projects or by the OECD Task Force on Environmental Exposure Assessment.

For a quantitative assessment of use of specific biocides, confidential production data has been reviewed by the study team at ECB in Ispra in July 2008 (Kj?lholt 2008).

Each PT description has a last section with an assessment of risks to humans and the environment from the use of the products in the PT in question. The assessment is not for the individual substances/products and their applications as this is taken care of in the EU review and decision process regarding inclusion of substances on Annex I of the BPD. Rather, it is an attempt to make a crude, overall/aggregated relative assessment of risk levels in a Community perspective.

For this purpose the following terminology to describe/rank risk levels (or priorities for possible action at Community level) is used: High/major - significant - moderate - low/insignificant.

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Table of Content

1

MAIN GROUP 1: Disinfectants and general

biocidal products

3

1.1 Product Type 1: Human hygiene biocidal products

3

1.2 Product-type 2: Private area and public health area

disinfectants and other biocidal products

6

1.3 Product-type 3: Veterinary hygiene biocidal products

12

1.4 Product-type 4: Food and feed area disinfectants

16

1.5 Product-type 5: Drinking water disinfectants

19

2

MAIN GROUP 2: Preservatives

22

2.1 Product-type 6: In-can preservatives

22

2.2 Product-type 7: Film preservatives

27

2.3 Product-type 8: Wood preservatives

31

2.4 Product-type 9: Fibre, leather, rubber and

polymerised materials preservatives

39

2.5 Product-type 10: Masonry preservatives

43

2.6 Product-type 11: Preservatives for liquid-cooling and

processing systems

47

2.7 Product-type 12: Slimicides

52

2.8 Product-type 13: Metalworking-fluid preservatives

57

3

MAIN GROUP 3: Pest control

61

3.1 Product-type 14: Rodenticides

61

3.2 Product-type 15: Avicides

65

3.3 Product-type 16: Molluscicides

67

3.4 Product-type 17: Piscicides

68

3.5 Product-type 18: Insecticides, acaricides and

products to control other arthropods

70

3.6 Product-type 19: Repellents and attractants

74

4

MAIN GROUP 4: Other biocidal products

78

4.1 Product-type 20: Preservatives for food or feedstock

78

4.2 Product-type 21: Antifouling products

80

Product-type 22: Embalming and taxidermist fluids

86

4.3 Product-type 23: Control of other vertebrates

89

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References

91

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Borderline issues

1 MAIN GROUP 1: Disinfectants and general biocidal products

1.1 Product Type 1: Human hygiene biocidal products

1.1.1 Application areas Human hygiene biocidal products are products used for human hygiene purposes. They 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.

The product-type includes the following products (van der Aa and Balk 2004):

? Hand disinfectants, disinfectant soap, antiseptic soap, antibacterial or antimicrobial soap, antibacterial or antimicrobial cleaning gel, antibacterial or antimicrobial cleaning solution;

? Fresh-up towels with a general disinfecting claim;

? Detergents and cleaning products (auxiliary aids for washing processes like fabric conditioners are included) intended to have a biocidal activity (reliably controlling micro-organisms like fungi and bacteria)

? Disinfectant mouth solution, antiseptic mouth solution (no therapeutic claims)

Biocides in cosmetic products and products specifically intended for medicinal purposes are beyond the scope of the Biocide Directive.

(van der Aa and Balk 2004)

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1.1.2 Substances under PT1 The EU review programme for biocidal substances comprise 85 substances in PT1 (a significant number also occur under other PTs). The most important of these (in terms of production tonnage) are benzoic acid, pentapotassium bis(peroxymonosulphate)-bis(sulphate), sodium benzoate and sodium hypochlorite (Kj?lholt 2008).

Substances in PT1 identified in a survey of biocidal products on the Danish market (Lassen et al. 2001) are listed in Table 1.1.

Table 1-1 Biocides used for skin disinfectants in Denmark

Chemical name (active agent)

Trivial name

2,4,11,13tetraazatetradecanediimidamide, N,N"-bis(4-chlorophenyl)-3,12diimino, diacetate

Ethyl alcohol

Phenol, 5-chloro-2-(2,4dichloropnenoxy)-

Iodine

D-gluconic acid, compound with N,N"-bis(4-chlorophenyl)-3,12diimino-2, 4,11,13-tetraazatetradecanediimidamide (2 :1)

chlorhexidine diacetate

surgical spirit triclosan

chlorhexidinedigluconate

CAS No % active agent in biocidal products

56-95-1

0.2

64-17-5 3380-34-5

7553-56-2 18472-51-0

70-85 0.3-3

0.01-5 0.5

1.1.3 Data on production/consumption A brief survey of the quantitative information on production volume contained in notification reports for biocides received by the European Chemicals Bureau has been undertaken in July 2008 as part of this study (Kj?lholt 2008). Production tonnage data (1998-2001) were obtained for almost 45 % of the substances in PT1 and the total production volume of these substances was 18,290 tonnes. The tonnage of the four most important substances made up 50 % of the total. The PT1 tonnage was 4.6 % of the total biocide tonnage (PT1-23).

In Denmark (1998/99) human hygiene biocidal products accounted for 1.7% of the total consumption of biocidal active substances.

1.1.4 Exposure of humans Skin antiseptics are used professionally (in hospitals) as well as privately. Some skin antiseptics like products for bathing are applied and used in the very short term. After this short service life the products are rinsed off with fresh water or released with wastewater after washing and bathing. Other skin antiseptics may stay on the human skin for a longer period after application. During this period

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of `service life' the product may transfer to the clothing and is removed when clothing is washed. Remains of the product on the human skin are removed during showering or bathing.

Products are applied as solutions, soaps, creams, gels, lotions and aerosols. Products for skin disinfection are marketed in the form of liquids, gels and powders which are used for washing or topical skin application.

Occupational exposure and exposure of consumers is consequently via direct dermal contact.

1.1.5 Exposure of the environment The environmental exposure of Product type 1 is very diffuse. The products are available as soap bars or liquid soap, sprays, gels, pastes, etc, all in small quantities. A distinction may be made between `rinse-off' and `non-rinse-off' or `leave-on' products. After application `rinse-off' products will usually be rinsed or washed off directly and most of the material will be discharged to the sewage treatment plant. For `leave-on' products it may be assumed that they will be washed off later of be rubbed of by clothing to be washed to the sewer at a later stage. In exceptional cases, they directly, after application, reach the fresh and marine surface water or the indoor air. (van der Aa and Balk 2004)

A special case is the application of volatile substances such as ethanol antiseptics. This use will cause an emission to air implying that only a small fraction might go to wastewater. (van der Aa and Balk 2004)

Another potential route of emission is the disposal of the packaging material together with remnants of the product, or the disposal of outdated products to a waste dump via the normal route of municipal waste. (van der Aa and Balk 2004)

1.1.6 Assessment of risk to humans and environment The production tonnage in PT1 is significant; probably more than 30,000 tons/year in the EU considering that the registered tonnage only covered 45 % of the substances.

The use type must be characterised as widely dispersive as virtually 100 % is applied directly to humans or lost immediately to the environment including the sewage system (i.e. to WWTPs).

On the other hand, the toxicity is assessed not to be critical as the active substances are intended for application to humans while the intended toxicity toward microorganisms may contribute to negative impacts on WWTP processes.

Overall, the risk to humans and the environment from the use of PT1 substances is considered to be moderate-low.

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