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EUROPEAN COMMISSIONDIRECTORATE-GENERALENVIRONMENTDirectorate D - Water, Marine Environment & ChemicalsENV.D.3 - Chemicals, Biocides and Nanomaterials

NOTE FOR DISCUSSION WITH COMPETENT AUTHORITIES FOR BIOCIDAL PRODUCTS

This document is an attempt to provide guidance in the interest of consistency, and has been drafted by the Commission services responsible for biocidal products with the aim

of finding an agreement with all or a majority of the Member States' Competent Authorities for biocidal products. Please note, however, that Member States are not

legally obliged to follow the approach set out in this document, since only the Court of Justice of the European Union can give authoritative interpretations on the contents of

Union law.

Subject: Guidance Documents on environmental risk mitigation measures for PT 1-5

The enclosed Guidance Documents on environmental risk mitigation measures for PT 1-5, were finalized at the Technical Meeting.

In assessing the impact of biocides to the environment, specific measures to reduce a possible risk to the environmental compartments may be required. First experiences in the evaluation of active substances showed that the Rapporteur Member States have followed different approaches of risk mitigation measures (RMM) for a given risk to the environment. Due to the short deadlines foreseen for mutual recognition of product authorisations this is a critical point because at this stage a harmonisation of RMM is difficult to realise. In February 2011 a European workshop on RMM for biocide use of PT 8 and 18 was held at the German Federal Environment Agency in Dessau resulting in the plan to develop product-type specific Guidance Documents with precise proposals for RMM.

The attached drafts of Guidance Documents were developed by the contractor Hydrotox GmbH for the PTs 1-5. These PTs represent a high percentage of the European market of biocidal products. Hence the upcoming process of product authorizations and mutual recognitions of these products will pose a challenge to Member States due to the high workload. The Guidance Documents are supposed to simplify the process by providing harmonised guidance on RMM. The final report of the project is provided as well with this letter to provide some background information on the development of the Guidance Documents.

A first draft of a Guidance Document for PT 4 was sent for comments to the Technical Meeting on Biocides (TM) in March 2012 and the received comments were included in the draft as far as feasible. This draft was used as the basis for the Guidance Documents

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111

for PT 1, 2, 3 and 5. These documents were sent to the TM in September 2012 for comments. The comments were all addressed.

The Competent Authorities are requested to agree that these Guidance Documents should now be released for a six-month consultation of stakeholders.

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ENVIRONMENTAL RISK MITIGATION MEASURES FOR HUMAN HYGIENE BIOCIDAL PRODUCTS (PT 1)

Several disinfectants of product types (PT) 1-5 are currently under evaluation within the review programme established by the Biocidal Products Regulation (EU) No 528/2012 (BPR) concerning the placing on the market of biocidal products.

This Guidance document describes Risk Mitigation Measures (RMM) for disinfectants used for human hygiene purposes to be considered during the authorisation of biocidal products as well as the evaluation of active substances, especially if an environmental risk is identified. PT 1 disinfectants cover products used for general human hygiene purposes with an anti-microbial claim. These have to be distinguished from cosmetics or medical products with a therapeutic claim not covered by the Biocide Directive (see Emission Scenario Document (ESD) for PT 1, European Commission 2004).

PT 1 biocides such as hand disinfectants or disinfectant soaps are mainly in the health service sectors, the food processing industry and other food handling areas or other workplaces as well as in private homes. The main emission route of “rinse-off” and “leave on” disinfectants is to sewage treatment plants (STP), either directly or after washing the clothes. Volatile substances such as ethanol antiseptics are mainly emitted to air. Impregnated and treated articles with a general disinfecting claim, such as fresh-up towels, may also be disposed of as waste, as product remnants and empty packages are.

Some of the active substances and/or other ingredients of the biocidal products are classified as harmful, toxic or very toxic to aquatic life and/or may cause long lasting effects according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances (CLP Regulation). Some substances could pose an unacceptable risk when released to the environment. If the risk assessment for disinfectant products results in an unacceptable environmental risk to aquatic or soil organisms, or to biological STP (PEC/PNEC > 1) these biocidal products may only be authorised if the risk can be reduced to an acceptable level by RMM (conditional authorisation).

In a study on behalf of the German Federal Environment Agency the existing environmental RMM for disinfectants (PT 1-5) proposed by different stakeholders were compiled and combined to a set of different RMM that the authorities can choose from during the product authorisation process, depending on identified risks. The different RMM for PT 1 are compiled in the annex of this document. Considering the progress of the review programme for existing active substances, this paper outlines a common approach for products authorisations and mutual recognition.

It should be noted, that there are RMM which refer to the product designers and formulators and others which refer to the user of a biocidal product. The efficiency and practicability of any RMM to be quantitatively considered must be evaluated in the risk assessment by authorities. In this respect, the possibility of enforcement and control of a RMM should be considered. Any RMM referring to the user of a biocidal product must be clearly indicated on the label.

Only environmental risks from the use of PT 1 disinfectants are considered in this guidance document so far.

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111

Risk mitigation measures for PT 1 disinfectants

Hand hygiene disinfectants and related products are an important tool in infection control by preventing the spread of pathogens. In healthcare facilities hand hygiene is considered one of the most effective measures for reducing healthcare associated infections. The use of disinfectants for professional uses should be integrated in a general hygiene strategy and best practices as described in numerous guidelines of hygienists. However, this is not applicable for private uses.

The development of (cross-) resistance of microorganisms to disinfectants has been observed after both correct use and especially after misuse of disinfectants. Resistance development may be prevented or reduced by the avoidance of application faults and of sublethal concentrations of the active substances as well as by the use of alternative substances ort methods. The development of resistance may lead to the need of higher concentrations or an increased frequency of use and thus to higher emissions. The development of cross-resistance of microorganisms to antibiotics following use and misuse of disinfectants is controversially discussed among hygienists.

RMM can refer to different addressees such as the industrial formulator, the supplier and distributor, the user of disinfectants, and authorities involved in the surveillance of good practices.

In this guidance document RMM are divided in general and specific RMM.

General RMM (e.g. general precautionary advice, best available techniques, good housekeeping, applying hygiene management systems) should be applied to all products, independent from the results of the risk assessment, if applicable and exemplify a way for the sustainable use of the disinfectants. This reflects the BPR that requires a proper use of the biocidal products. This use shall also involve the rational application of a combination of physical, biological, chemical or other measures as appropriate, whereby the use of biocidal products should be limited to the minimum necessary (Art. 3(7)). They describe reasonable conditions of use and reflect common sense. The intention is to avoid misapplication of disinfectants. However, general RMM cannot be used in the environmental exposure assessment in quantitative terms, because the effect on the emissions and the compliance cannot be proven.

Specific RMM result from the risk assessment and are suitable for a quantitative reduction of the exposure through modification of the respective emission scenarios. Note that RMM for users have to be clearly communicated with the label or product leaflets. Specific RMM are designed to reduce an identified environmental risk (PEC/PNEC > 1) to an acceptable level. The efficiency and practicability of specific RMM has to be proven by the applicant for authorisation of a biocidal product by submitting sound data or studies. Some RMM might also be appropriate if the risk quotient shows a level of concern (e.g. PEC/PNEC > 0.1). Some RMM might also be appropriate if the risk quotient shows a level of concern (e.g. PEC/PNEC > 0.1). This may e.g. be the case if a substance is used in different PT simultaneously. Specific RMM should be considered in the revision of Emission Scenario Documents (ESDs) as far as possible in order to harmonise the approach. If they represent the way the product is commonly applied the efficiency of the RMM could be quantified.

Specific RMM can be attributed to different categories described below. The precise RMM for each category and specific unacceptable risks can be found in the annex I of

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this document. It should be noted that some RMM, whose main focus is on human health, nonetheless indirectly lead to lower exposure to the environment e.g. because specific uses or user categories are excluded. These are also included in the document.

Category of users

Disinfectants for human hygiene purposes are mainly intended for professional use such as nurses, cleaning staff, employees in the food and feed area and other user which apply disinfectants in the course of their professional activities. PT 1 disinfectants are also marketed for consumer use. The benefits of consumer use of PT 1 disinfectants is controversially discussed among hygienists who argue that untrained consumer often do not apply disinfectants effectively. With respect to RMM for consumer uses of disinfectants only short and simple instructions are likely to be implemented by the user. Thus, emphasis should be on product integrated RMM under the control of the supplier (chemical composition and design). The product label should communicate all instructions on safe use, storage and disposal to consumers. These instructions are mainly attributed to general RMM which cannot be quantitatively assessed.

For certain disinfection activities and/or the use of active substances, which are very toxic, toxic or which may cause long lasting effects the use may be restricted to specifically trained and certified professional users.

Generally, to exclude consumer uses of PT 1 disinfectants intended for professional use these must not be offered in open shelves or internet commerce through self service.

Area of use

Disinfectants used for human hygiene are mainly applied to human skin and therefore have a relatively narrow area of use (public and private healthcare facilities, food industry and commerce, private homes etc.).

The practicability of RMM concerning the area of use depends on the unambiguous description of allowed uses but any misuse may not be prevented. Because the intended uses determine the emission scenarios to be assessed, these RMM may be considered in quantitative terms.

Composition

The composition of a disinfectant product is under the control of the formulator and immediately has an influence on potential risks to the environment. All products with ingredients which have been classified in environmental risk phrases (H400, H410-H413) according to the CLP Regulation should be evaluated for possible risks and potential substitutes. From an environmental point of view the selection of biodegradable active substances such as alcohols and environmental sound additives should be preferred.

Formulation

PT 1 disinfectants are usually applied by spraying, washing or hand rubbing with ready- for-use products. In certain circumstances, accurate dosage may be supported by appropriate equipment.

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Product integrated RMM such as those which determine the formulation may be quantitatively considered in the exposure assessment.

Packaging and pack size

The package size also may help reducing environmental exposure by avoiding the release/disposal of expired products. Product designs supporting the application of disinfectants through accurate dosing should be preferred. Therefore, where appropriate, the placing on the market may be restricted to certain specific product design.

Product integrated RMM may be optimized by product developers and discussed with authorities. They could be considered in the exposure assessment in quantitative terms if appropriate.

Treatment and/or disposal

The main emission pathway for PT 1 disinfectants is to sewage water treatment plant (STP) and to the air.

Considering the narrow application area, the application of ready-for-use products and the main emission route to STP there remain few options for specific RMM. These may only be considered in quantitative terms in the exposure assessment if they are implemented in routine practice by the user and if some surveillance by authorities is carried out.

Labelling

Article 69 (1) of the Biocidal Products Regulation (EU) No 528/2012 stipulates that biocidal products shall be labelled in accordance with the provisions of Directive 1999/45/EC relating to the classification, packaging and labelling of dangerous preparations, now amended by Regulation (EC) No 1272/2008. However the requirements of these legislations may not allow a sufficient description of the special risks which may arise during the use of disinfectants. Therefore, additionally standard phrases should allow a sufficient description of the special risks and of the safety precautions to be taken1. Thus, in addition to the elements already listed in Article 20(3), product labels or the packaging of disinfectants should show the safety precautions for the protection of humans, animals or the environment. These safety precautions should always be carried on the label of the products or on an accompanying leaflet together with the other directions for use and disposal of the product. Reference only to an internet source is not sufficient.

Codes of Good Practices

The careful use of disinfectants is essential to minimise risks for human health and the environment. Frequent use of hand hygiene agents should be integrated in a general hand care concept.

For human hygiene disinfectants many good and best practice documents and training courses have been developed. Maintaining good hygiene practice and repeated training is a prerequisite for human hygiene disinfectants being effective. The hygienic design of

1 This is by analogy to what has been done in the PPP area where standard phrases for special risks and safety precautions for plant-protection products have been established..

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the equipment supports minimising the amount of disinfectant. Several good and best practice documents cover the human hygiene area. Some non-exclusive examples are:

WHO 2009. WHO Guidelines on Hand Hygiene in Health Care. World Health Organization whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf

Centers for Disease Control and Prevention 2002. Guideline for Hand Hygiene in Health-Care Settings - Recommendations of the Healthcare Infection Control Practices. Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force, Morbidity and Mortality Weekly Report (MMWR) 2002 (5), 56 pages http://www.cdc.gov/mmwr/PDF/rr/rr5116.pdf

Fraise, A. P., Lambert, P. A., Maillard, J. Y 2003. Russell, Hugo and Ayliffe's Principles and Practice of Disinfection, Preservation & Sterlization. Blackwell Publishers

Kampf, G., Löffler, H., Gastmeier, P. 2009. Review: Hand Hygiene for the Prevention of Nosocomial Infections. Deutsches Ärzteblatt International 106(40), p. 649–655 http://www.aerzteblatt.de/pdf.asp?id=66218

RKI. 2000. Empfehlungen Händehygiene - Mitteilung der Kommission für Krankenhaushygiene und Infektionsprävention am Robert Koch-Institut. Bundesgesundheitsbl. Gesundheitsforsch. – Gesundheitsschutz. 43, p. 230–233 http://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Kommission/Downloads/Haendehyg_Rili.pdf

In addition to product labelling and instructions for use, several good and best practice documents should be made available to the user.

RMM referring to codes of good practice may only be considered in quantitative terms in the exposure assessment if these good practices are well established in professional use of disinfectants and if some surveillance by authorities is carried out. The practicability of these RMM is not under the control of the authorisation process for disinfectants. RMM regarding good practices do not apply for consumer uses of disinfectants.2

2 This is in compliance to the risk management measure discussed under REACH where many RMM communicated to consumer are not applicable for quantitative considerations, due to unknown compliance. http://www.cefic.org/Industry-support/Implementing-reach/Libraries/

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Annex I

In this annex RMM for products used in the PT 1 are proposed.

General RMM

The named general RMM should be applied to all products, if suitable, not depending on eventually identified risks but to propose a sustainable use of disinfection products. Italic words written in brackets should be adapted on the respectively application of the biocidal product. They have only replacement character and illustrate proposals. The Precautionary Statements of the CLP Directive are not repeated here.

Take care for general good housekeeping and good hygiene practice

Only apply consumer disinfectants according to the targeted hygiene concept in situations and areas with higher risks for transmission of pathogens.

Read the [label/ attached instruction] before use.

Dispose of waste product or used containers according to local regulations.

Only pass on empty containers/packaging for recycling.

Do not dispose off as municipal waste; dispose of as hazardous waste.

Avoid [direct] release of [undiluted] product into the [sewage system or the environment].

Washing of the hands required before using disinfectants.

Before deciding to use disinfectants it should be examined whether disinfection in fact is required. Restrict the extent and frequency of disinfection measures to the minimum necessary.

Specific RMM

Depending on the origin of the identified unacceptable risks suitable RMM can be chosen from this list of standardised RMM phrases. The following abbreviations are used: W: Water, G: Groundwater, S: Soil, A: Air, STP: Sewage Treatment plant, PSP: Primary and Secondary Poisoning. Italic words written in brackets should be adapted on the respectively application of the biocidal product. They have only replacement character and illustrate proposals.

No Category Risk in environmental compartments

Specific RMM Remarks

1 Category of user

W, STP Only professional uses are allowed.

or

Applications only by professional user with expert knowledge

PT 1 disinfectants are mainly designed for professional uses but there exist also consumer uses. To exclude private uses do not offer in open shelves or other forms of self service.

2 Composition W, STP The following additives [add the additives such as detergents, complexing agents] should be ultimately biological degradable in accordance with [add e.g. Regulation (EC) No. 648/2004 on detergents].

RMM referring to the environmental soundness of non-biocidal additives.

3 W, STP The following additives [add the additives] should be eliminated by 80% of the dissolved organic carbon (DOC) or of the chemical oxygen demand (COD) in the [add the test method, e.g. Zahn-Wellens test according to EN 9888].

RMM referring to the product formulation with certain requirements concerning the treatability of additives in STP.

4 W, STP Avoid the use of halogenated biocides, except where the alternatives are not effective.

To be applied where halogenated biocides are used.



5 Treatment and/or disposal

W, G To protect in water living organisms, prevent that residues containing the product enter the sewer and apply the following safety measures: ["…"].

Place-holder for environmental RMM.

6 W, STP To protect water living organisms and micro-organisms in the STP, it is not permitted discharge spills and residues containing the product to the sewer or surface water.

RMM for industry and other professional institutes where in practice the product is collected and disposed after use.

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ENVIRONMENTAL RISK MITIGATION MEASURES FOR DISINFECTANTS USED IN THE PRIVATE AND PUBLIC HELTH AREA AND OTHER

BIOCIDAL PRODUCTS (PT 2)

Several disinfectants of product types (PT) 1-5 are currently under evaluation within the review programme established by the Biocidal Products Regulation (EU) No 528/2012 (BPR) concerning the placing of biocidal products on the market.

This Guidance document describes Risk Mitigation Measures (RMM) for disinfectants used in the private and public health area (PT 2) to be considered during the authorisation of biocidal products as well as the evaluation of active substances, especially if an environmental risk is identified. The PT 2 disinfectants cover very diverse application areas and are therefore divided in the following subgroups (see Emission Scenario Documents for PT 2 and its supplement, European Commission 2002, 2011).

sub PT *) Private area and public health area disinfectants and other biocidal products

2.1 Swimming pools

2.2 Sanitary sector

2.3 Horticulture

2.4 Tiles and surfaces

Medical sector

2.5 - Disinfection of rooms, furniture and objects - Disinfection of instruments

2.6 - laundry disinfectants

2.7 - hospital waste disinfectants

2.8 - disinfection of air conditioning systems

Disinfection in industrial and institutional areas

2.9 - Disinfectants for sewage and wastewater

2.10 - Soil and other disinfectants

2.11 - Disinfection of chemical toilets

*) There does not exist an official attribution of sub-PT numbers but these are introduced here for a better structuring.

The COWI study concluded that the largest use area is for disinfection purposes in private and public health areas (PT 2) where about 50% of the overall tonnage from all biocidal actives is consumed.3

The main emission route for PT 2 disinfectants are municipal sewage treatment plants (STP) and surface water as well as sediments (either through direct discharges e.g. of swimming water or from the outflow of STPs). For some disinfection application such as

3 http://ec.europa.eu/environment/biocides/pdf/report_use.pdf

non-contained disinfection processes or fumigation, there is some potential for direct emission to the air and soil.


In a study on behalf of the German Federal Environment Agency the existing environmental RMM for disinfectants (PT 1-5) proposed by different stakeholders were compiled and combined to a set of different RMM that the authorities can choose from during the product authorisation process, depending on identified risks. The different RMM for PT 2 are compiled in the annex of this document. Considering the progress of the review programme for existing active substances, this paper outlines a common approach for products authorisations and mutual recognitions.




Disinfectants used in the private and public health area are an important tool for maintaining hygiene conditions and for infection control by preventing the growth of microbiological pathogens. The use of disinfectants for professional uses is usually integrated in a general concept or management system for good hygiene practice according to European and national legislation. This is not applicable for private uses.

Several active substances may be rapidly degraded by chemical-physical processes during application or biodegraded in STP. Other active substances may be toxic and/or may cause long lasting effects. STPs are important intermediate compartments for PT 2 disinfectants and need to be protected from substances inhibitory to the activated sludge organisms.

In addition, disinfectants may also be directly discharged to surface water depending on the capacity of the on-site wastewater (pre)treatment plant and/or the connection to a sewer discharging to municipal STPs. Another source for direct discharges is the storm water overflow of STPs. Depending on the chemical properties of the active substances evaporation to the air might also be a major pathway e.g. for aldehydes and alcohols. In STP the concentration might decline through chemical reactions e.g. with proteins.

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Further on, some oxidative disinfectants may react to disinfection by-products (DBP) with inorganic or organic matter present in water. Many DBPs are harmful and may pose a risk to the environment and/or form persistent organic compounds and adsorbable organic halogens (AOX) which also raises environmental concerns. A background document on the assessment of DBP is being developed by CAs where it is proposed inter alia to carry out PEC/PNEC-assessments of DBP based on monitoring data from the biocide uses subjected to authorisation. The results of these risks assessments should be taken into account when considering RMM for the respective products.

The development of (cross-) resistance of microorganisms to disinfectants has been observed both after correct use and especially after misuse of disinfectants. Resistance development may be prevented or reduced by the avoidance of application faults and of sublethal concentrations of the active substances as well as by the use of alternative substances or methods. The development of resistance may lead to the use of higher concentrations or an increased frequency of use and thus to higher emissions. The development of cross-resistance of microorganisms to antibiotics following use and misuse of disinfectants is controversially discussed among hygienists.

Treated articles with a biocidal claim such as antimicrobial textiles or surfaces are covered by the BPR and must be authorised as biocidal product while the efficiency of the claim must be proven by sound data. RMM for treated articles mainly cover the end of use part of the life cycle and may be regarded as general RMM.

RMM can refer to different addressees such as the industrial formulator, the supplier and distributor, the user of disinfectants, and authorities involved in the surveillance of good practices.



Specific RMM result from the risk assessment and are suitable for a quantitative reduction of the exposure through modification of the respective emission scenarios. Note that RMM for users have to be clearly communicated with the label or product leaflets. Specific RMM are designed to reduce an identified environmental risk (PEC/PNEC > 1) to an acceptable level. The efficiency and practicability of specific RMM has to be proven by the applicant for authorisation of a biocidal product by submitting sound data or studies. Some RMM might also be appropriate if the risk quotient shows a level of concern (e.g. PEC/PNEC > 0.1). Some RMM might also be appropriate if the risk quotient shows a level of concern (e.g. PEC/PNEC > 0.1). This may e.g. be the case if a substance is used in different PT simultaneously. Specific RMM should be considered in the revision of Emission Scenario Documents (ESDs) as far as

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possible in order to harmonise the approach. If they represent the way the product is commonly applied the efficiency of the RMM could be quantified.

Specific RMM can be attributed to different categories described below. The precise RMM for each category and specific unacceptable risks can be found in the annex I of this document. It should be noted that some RMM, whose main focus is on human health, nonetheless indirectly lead to lower exposure to the environment e.g. because specific uses or user categories are excluded. These are also included in the document.

Category of users

Disinfectants of PT 2 are principally intended for professional and industrial use, although some application areas also include consumer uses (home disinfectants, swimming water disinfectants, water additives for mobile toilets etc.). Professional users are persons who use disinfectants in the course of their professional activities, including operators, technicians, employees. Industrial user apply disinfectants e.g. in the production of packaging materials, pharmaceuticals or cosmetics as well as in biotechnology.

For certain disinfection activities and/or the use of active substances, which are very toxic, toxic or which may cause long lasting effects the use may be restricted to specifically trained and certified professional users. The same applies to certain modes of applications such as fumigation.

The benefits of consumer use of PT 2 disinfectants is controversially discussed among hygienists who argue that untrained consumer often do not apply disinfectants effectively. With respect to RMM for consumer uses of disinfectants only short and simple instructions are likely to be implemented by the user. Thus, emphasis should be on product integrated RMM under the control of the supplier (chemical composition and design). The product label should communicate all instructions on safe use, storage and disposal to consumers. These instructions are mainly attributed to general RMM which cannot be quantitatively assessed.

Generally, to exclude non-professional (consumer) uses of PT 2 disinfectants these must not be offered in open shelves or internet commerce through self service.

Area of use

Disinfectants used in the private and public health area usually are specifically designed for the disinfection of surfaces, instruments, air condition systems, laundries, swimming water etc., thus excluding other uses. The area of use will mainly be derived from the intended uses indicated by the applicant which have to be supported by efficacy testing but may be restricted when risks are identified. Specific provisions on the area of use could be combined with other provisions, in particular with those on the category of users and on the product design.

The area of use may also contribute to reduce the formation of DBP through the use of some oxidative disinfectants, e. g. by avoiding areas where the inorganic or organic precursors of such DBP are known and present.

The practicability of RMM concerning the area of use depends on the unambiguous description of allowed uses but any misuse may not be prevented. Because the intended

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uses determine the emission scenarios to be assessed, these RMM may be considered in quantitative terms.

Composition

The composition of a disinfectant product is under the control of the formulator and immediately has an influence on potential risks to the environment. All products with ingredients which have been classified in environmental risk phrases (H 400, H410-H413) according to the CLP Regulation should be evaluated for possible risks and potential substitutes. The possible formation of DBPs should also be considered.

Formulation

PT 2 disinfectants are usually applied by spraying, foaming, soaking, brushing or direct addition to water. Often the working solutions are made up from concentrates via automatic dosing pumps. In certain circumstances, the formulation of the product may help to reduce the risk for the environment through accurate dosage and avoidance of spillages.

The possible formation of DBPs should also be considered when evaluating the formulation.



The packaging of the product also plays a role and can be used to reduce environmental exposure by avoidance of overdosage. Product designs supporting the application of disinfectants through accurate dosing e.g. via dosing pumps should be preferred. Therefore, where appropriate, the placing on the market should be restricted to certain specific product design.



The main emission pathway for PT 2 disinfectants is via the sewer system either to an on-site STP or to a municipal STP. Avoidance of peak loads discharged to biological treatment plants or neutralisation of the active substance are RMM for reducing acute toxicity to activated sludge.

Obligatory discharge of the wastewater to a well-functioning municipal STP might be considered as a RMM. Note, that the proportion of the population connected to urban wastewater treatment within Europe shows considerable differences (between ca. 30% and 95%).4 If no STP is existent in a community it can be expected that direct releases of wastewater from the food and feed area including disinfectants to surface water is very likely.

4 http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Water_statistics15

These RMM may only be considered in quantitative terms in the exposure assessment if they are implemented in routine practice by the user and if some surveillance by authorities is carried out.

Labelling



The careful use of disinfectants is essential to minimise risks for human health and the environment. In many application areas for disinfectants good and best practice documents and training courses have been developed by authorities and professional associations. Maintaining good hygiene practice and good housekeeping is a prerequisite for disinfectants being effective. Hygienic design of the equipment and the facility helps minimising the amount of disinfectant. Several good and best practice documents as well as technical standards cover the PT 2.6 Some non-exclusive examples are:

Hospitals and healthcare facilities

Fraise, A., Lambert, P. A., Maillard, J. Y. (Ed.) 2004. Russell, Hugo & Ayliffe's Principles and practice of disinfection, preservation and sterilization. Wiley-Blackwell, 4th edition.

TRGS 525 (5/1998) Umgang mit Gefahrstoffen in Einrichtungen zur humanmedizinischen Versorgung. (Hazardous substances in health care facilities)

RKI 2004. Anforderungen an die Hygiene bei der Reinigung und Desinfektion von Flächen - Empfehlung der Kommission für Krankenhaushygiene und Infektionsprävention beim Robert Koch-Institut (RKI), Bundesgesundheitsbl - Gesundheitsforsch - Gesundheitsschutz 47, p. 51–61

RKI 2007. Liste der vom Robert Koch-Institut geprüften und anerkannten Desinfektionsmittel und –verfahren Stand vom 31.5.2007 (15. Ausgabe) Bundesgesundheitsbl - Gesundheitsforsch - Gesundheitsschutz 50, p. 1335–1356

Rutala, W. A., Weber, D. J. 2008. Guideline for Disinfection and Sterilization in Healthcare Facilities. Healthcare Infection Control Practices Advisory Committee

5 This is by analogy to what has been done in the PPP area where standard phrases for special risks and safety precautions for plant-protection products have been established.

6 A more detailed analysis of available best practice documents has been elaborated in 2010 within a study on behalf of the European Commission. http://ec.europa.eu/environment/biocides/sust_use.htm

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(HICPAC) http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf

Disinfectants in consumer products

Anonymous 1999. Hygiene Code for the private household based on the Dutch situation. Netherlands Nutrition Centre http://www.nutricion.org/publicaciones/pdf/hygiene_codehouses.pdf

Swimming pools DIN 19643 part 1 to 5 (4/1997 – 9/2000). Aufbereitung von Schwimm- und

Badebeckenwasser (Treatment of water of swimming pools and baths) WHO 2006. Guidelines for safe recreational water environments, VOL. 2

Swimming pools and similar environments. http://www.who.int/water_sanitation_health/bathing/en/

Laundry disinfectants BS EN 14065 (12/2010). Laundry Processed Textiles – Biocontamination control

system RKI-Guideline on accepted disinfectants and disinfection processes (RKI 2007).

Air conditioning systems VDI 6022 pat 1, 3, 4, 6 (7/2011 – 8/2012). Ventilation and indoor-air quality -

Hygiene requirements for ventilation and air-conditioning systems and units. DIN 1946-4 Ventilation and air conditioning: part 4: VAC systems in buildings

and rooms used in the health care sector (12/2008), Part 7: Ventilation systems in laboratories (7/2009).

Wastewater discharge and chemical toilets ATV-M-270 (5/1997). Entsorgung von Inhalten mobiler Toiletten mit

Sanitärzusätzen (Chemietoiletten) (Disposal of the content of mobile toilets with sanitary additives (chemical toilets). Deutsche Vereinigung für Wasserwirtschaft, Abwasser und Abfall e. V (DWA)

DVWK-M 775 (12/2010): Abwasser aus Krankenhäusern und anderen medizinischen Einrichtungen. (Waste water from hospitals and other medical facilities.) Deutsche Vereinigung für Wasserwirtschaft, Abwasser und Abfall e.V. (DWA)

BS EN 12255-14 (1/2004). Wastewater treatment plants. Disinfection.

National legislations on wastewater discharges often provide requirements which have an impact on the selection of PT 2 disinfectants. For example, the German Wastewater Ordinance defines limit values of the AOX concentration and thus restricts the use of organically bonded halogen compounds or halogen-releasing substances.7 The technical

7 For example the AOX load at the point of discharge for hospital and residential home laundries, according to Annex 55 of the German wastewater ordinance, is limited to 18 g/t and that for working clothes from the meat and fish-processing industry to 40 g/t (before mixing with other waste water).

17

http://www.nutricion.org/publicaciones/pdf/hygiene_codehouses.pdf

http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf

standards for swimming water procession DIN 19643 parts 1 to 5 describe minimum and maximum treatment levels. The formation of Trihalomethane compounds resulting from chlorination is limited to of 0.02 mg/l. The formation of DBP could partly be managed by avoidance and/or removal of the inorganic or organic precursors.

The hygienic requirements in laundries and its quality assurance have been described in the (voluntary) Risk Analysis and Biocontamination Control concept (RABC) according to EN 14065.

In addition to product labelling and instructions for use, several good and best practise documents should be made available to the user.

RMM referring to codes of good practice may only be considered in quantitative terms in the exposure assessment if these good practices are well established in professional use of disinfectants and if some surveillance by authorities is carried out. The practicability of these RMM is not under the control of the authorisation process for disinfectants. RMM regarding good practices do not apply for consumer use of disinfectants.8


18

Annex I


General RMM


Take care for general good hygiene and housekeeping.




Do not mix with other products.

Precleaning of surfaces required before using disinfectants. Rinse the used cleaning agent and remove the redundant water.




Before deciding to use disinfectants it should be examined whether disinfection in fact is required. Restrict the extent and frequency of disinfection measures to the minimum necessary and substitute chemical disinfection by thermal or other methods where possible.

Permitted is only the use as disinfectants to control [organisms] (derived from efficacy tests) on [area] (such as surfaces, in and on walls and other building materials …. )] in [locations] (e.g. hospitals, and other health care facilities, industrial production systems)]

Specific RMM




1 Category of users

W, G, S, STP Only professional uses are allowed. PT2 disinfectants designed for professional uses. To exclude private uses do not offer in open shelves or other forms of self service.

2 W, G, S, STP, A Application only by professional user with certificate of competence for [fumigation operations].

3 Area of use W, G, S, STP To protect [water living organisms / activated sludge organisms] cleaning and disinfection [of …] should be carried in automatic systems.

RMM for instrument disinfectants

4 W, G, STP Use organic chlorine and chlorine-releasing compounds or chlorine only in the clear rinsing zone or the clear rinsing bath when washing in order to reduce the formation of disinfection by-products.

RMM e.g. for laundry disinfectants to reduce the formation of DBP

5 Composition W, G, S, STP The following additives [add the additives such as detergents, complexing agents] should be ultimately biological degradable in accordance with [add e.g. Regulation (EC) No. 648/2004 on

RMM referring to the environmental soundness



detergents]. of non-biocidal additives.

6 W, G, S, STP The following additives [add the additives] should be eliminated by 80% of the dissolved organic carbon (DOC) or of the chemical oxygen demand (COD) in the [add the test method, e.g. Zahn-Wellens test according to EN 9888].


7 Packaging and pack size

W, G, S, STP The size of the package placed on the market should be proportionate to the duration of the treatment and appropriate to the pattern of use of particular user groups.

Minimisation of the overall load through accurate dosage and avoidance of accidents and disposal of active substances.

8 W, G, S, STP Ensure that splashes and spills are avoided by product design. RMM directed to the formulator and referring to the product design (apparatus, packaging).

9 W, G, S, STP Provide in small packages [add the maximum package size] only. RMM directed to the formulator, small packages may help reducing consumption and disposal.

21



10 Formulation W, G, S, STP Use automatic dosage equipment instead of manual mixing and loading.

Accurate dosage helps avoiding misapplication and reducing the volume of the working solution and of the amount used and discharged.

11 W, G, S, STP Use a self-dissolving package that is added to reaction mixture without opening.

Accurate dosage helps avoiding misapplication and reducing the volume of the working solution and of the amount used and discharged


W, G, S, STP To protect in water living organisms, prevent that residues containing the product enter the sewer and apply the following safety measures: ["…"].


13 W, G, S, STP All waste water must be processed in an industrial or municipal wastewater treatment plant that incorporates both primary and secondary treatments.

Onsite pre-treatment required by [suitable techniques] with a removal

Specify conditions and measures related to the onsite or municipal sewage treatment plant if appropriate (e.g. biological treatment, neutralization, minimum

22



efficiency of [expression of threshold or %] before discharging into sewer.

Neutralization or inactivation [is normally] required before discharge into [sewage system / into water treatment plants].

grade of elimination). To be justified with sound data and evaluated in the risk assessment.


W, G A storm water management plan is needed to ensure that the wastewater treatment plant is not overloaded with uncontaminated water.

Avoidance of a STP-bypass of contaminated water through storm water. Only practicable for Member states which have developed storm-water provisions.

15 W, G To protect surface water biological treatment operation needed before release of biodegradable disinfectants into surface water.

The minimum grade of elimination in the sewage plant required is [ x %].

To be proven with sound data and evaluated in the risk assessment.

16 W, G To protect water living organisms, this product may only be applied if spills and residues containing the product are discharged to the sewer connected to the STP.

Prevention of direct discharge to surface water.

23



17 W, G, S To protect [water living organisms, groundwater and soil organisms], application of this product is restricted to areas with a hard standing. Spills and residues containing the product need to be discharged to the sewer [with connection to a STP].

RMM referring to the application area

18 W, G, S To protect soil and water living organisms, application of this product is restricted to indoor areas or areas under roof with a hard standing, where drain away to soil or surface water can be prevented.

RMM where local treatment outdoors may occur, but emission to soil and water must be prevented and considered possible in practice.


W, G, S To protect water living organisms, do not apply this product near water drainage systems.

RMM where local treatment outdoors may occur and emission water must be prevented.

20 W, G, STP To prevent the inhibition in functioning of an on-site wastewater treatment system and to protect aquatic organisms, possible residues containing the product must be discharged to a municipal STP.

RMM referring to wastewater treatment requirements

21 W, S, STP To protect water living organisms and micro-organisms in the STP, it is not permitted to discharge spills and residues containing the product to surface water or the sewer.

RMM for industry and other professional institutes where in practice the product is collected and disposed

24



after use.

22 W, G To protect water living organisms, residues containing the product should be discharged to the sewer connected to the STP. For disinfection of surfaces >2000 m2, the sewer connection of that facilities must be preceded by a sediment grease separation tank conform EN 1825-1 and 2.

Removal efficiency to be proven by sound data.

23 W, G, STP Ensure process wastes are transferred to storage containers.

A retention period of the disinfectant working solution of x days leads to considerably less contaminated wastewater compared to working solutions which are changed every day.

Intermediate storage of wastewater until the disinfection agents are inactivated. Removal efficiency to be proven by sound data.


W, G, STP Limit release rate to waste water to (kg/day):

To protect water living organisms only use in CIP-treatment when recirculation of the cleaning solution for minimizing releases to wastewater is applied.

Minimization of amount used through recycling of cleaning solution. RMM to be considered in wastewater permits and inspected by authorities. Only practicable if enforcement can be monitored.

25 W, G, S, STP Ensure all waste water is collected and treated via a STP. Obligatory connection of the sewer to a well-

25



If discharging to municipal sewage treatment plant, no onsite wastewater treatment required.

If discharging to municipal sewage treatment plant, provide the required onsite wastewater removal efficiency of [… (%)].

functioning municipal STP.

26 G, S Ensure that sludge from treatment operation is not spread to soil in agriculture, horticulture and grassland.

RMM for industrial on-site wastewater treatment plants only practicable if enforcement is supervised by authorities. Does not apply if the sludge is burnt.

27 STP Prevent adverse effects on municipal sewage treatment by limiting [concentration in waste water to ….. mg/l] [load in waste water to … kg/d].

Risk based evaluation of the maximum amount allowed to be used. RMM to be derived from the risk assessment only prac-ticable if enforcement is monitored by authorities.


W, G, S, STP If the concentration of [add name of active substance] in the [sewer system, inlet of the STP] exceeds the maximum allowable concentration of [indicate limit concentration] collect the disinfectant and dispose them as hazardous waste.

Risk based decision of the disposal of working solutions. RMM to be derived from the risk assessment only practi-

26



cable if enforcement is monitored by authorities.

29 W, G, S, STP If concentrations of [add name of active substance] in the sewer system exceed maximum allowable concentration of [indicate limit concentration] neutralize [e.g. glutaraldehyde with glycine, chlorine with sodium bisulfite].

Treatment of the working solutions. RMM to be proven by sound data, generation of disinfection by-products to be evaluated.

30 STP Avoid peak loads through continuous discharge to the wastewater. RMM for the protection of the activated sludge organisms to be proven by sound data. May be concluded in wastewater permits. Only practicable if enforcement is monitored by authorities.

31 A Limit emission to [air] by [technique] with an efficiency of not less than [efficiency rate]. The [filtered/scrubbed/absorbed/precipitated substance should/can be …].

RMM derived from the risk assessment to be proven by sound data.

32 PSP Take the necessary precautions to prevent exposure of [bats] and other protected animals in the gassed areas / spaces / structures / buildings.

RMM referring to the protection of specific non-target animals.

27




STP, W, G, S Use a sampling system for determining environmental exposure. RMM only practicable if results from monitoring triggers the use of a disinfectant. Also to be used as a control for the efficiency of an on-site treatment plant.

34 STP, W, G Dry cleaning of containers and equipment and disposal via solid waste in order to minimize releases to water.

Do not clean empty containers, but return them to the manufacturer or retailer.

RMM referring to product design and recollection of packaging

35 W, G Avoid the use of halogenated oxidising biocides, except where the alternatives are not effective.

In order to achieve efficacy and to minimize the formation of disinfection by-products (DBP) remove total organic carbon (TOC) and other precursor compounds prior to adding the disinfectant.

Substitution of halogenated oxidizing biocides is recommended in BREFS.

To be applied where halogenated oxidizing biocides are used.

36 A Not to be used in conjunction with chlorine releasing cleaning agents. RMM for avoiding chlorine releases from the use of acid disinfections

28



Laundry disinfectants


W, G, S, STP The waste water must not contain biocides from the finishing of washed items in standing baths.

RMM for avoiding DBP in laundries (German Wastewater Ordinance, Appendix 55).


W, G, S, STP The waste water must not contain organic chlorine and chlorine-releasing compounds or chlorine where these are not used in the clear rinsing zone or the clear rinsing bath.


39 W, G, S, STP The waste water must not contain chlorination chemicals (if used to prepare the process water) above 1 mg/l free chlorine in the influent to the washing machine.


Wastewater discharge and chemical toilets


W, G, S, STP Collect the content of chemical toilets in storage tanks and transfer it to sewage treatment plants. Ensure that only 2 m³ per day of mobile toilet content are discharged into a STP designed for 10.000 inhabitant equivalents.

RMM for avoiding discharges of sanitizers used in chemical toilets to the environment and avoiding peak loads in

29



STP (ATV-M-270).

41 W, G, S, STP Before releasing disinfectants from chemical toilets to sewage treatment plants maintain a storage time of [x d].

RMM for ensuring the inactivation of sanitizers to be confirmed by sound data.

42 W, G, S, STP Reduce residual concentrations of [indicate the oxidative disinfectant] by [indicate the technique, e.g. filtration, addition of reducing agents] before discharging the wastewater to surface water.

RMM for disinfection of municipal wastewater

30

ENVIRONMENTAL RISK MITIGATION MEASURES FOR VETERINARY HYGIENE PURPOSES (PT 3)


This Guidance document describes Risk Mitigation Measures (RMM) for disinfectants used for veterinary hygiene purposes to be considered during the authorisation of biocidal products as well as the evaluation of active substances, especially if an environmental risk is identified. PT 3 disinfectants cover products used to disinfect the materials and surfaces associated with the housing or transportation of animals as well as products for the disinfection of footwear and animals' feet, non-medicinal teat dips, disinfection of milk extraction systems, hatcheries, and fish farms (see Emission Scenario Document (ESD) for PT 3, European Commission 2011). Consumer use of PT 3 disinfectants comprise products used for disinfecting the surroundings of pets or other non-medical products such as disinfecting soaps or other hygiene products with anti-microbial function.

The main emission route to the environment for PT 3 disinfectants is to manure/slurry, air and agricultural soil (from spreading of manure/slurry). Run-off as well as leaching processes after manure/slurry application to agricultural soil can also lead to exposure of biocides to surface water and groundwater, respectively.. In general, across Europe, it is prohibited to discharge waste water containing slurry to the public (municipal) sewer, and hence liquid waste containing manure is either removed to a slurry or waste water collection tank and may be subsequently applied to agricultural soil or treated in a municipal on-farm sewage water treatment plant (STP). In contrast, PT 3 products applied for the disinfection of vehicles used for animal transport or from milking parlours outside the stable are mainly emitted to waste water treated in on-site STPs or in municipal STPs. Disinfectants from animals feet disinfection or from footwear disinfection might be discharged either to the slurry system or to the waste water. Disinfection with chemical agents is often accompanied by physical (e.g. thermal) treatment and the temperature of the treatment area has a decisive influence on the efficiency of disinfection process (next to other factors such as the duration, the organic load, the pH, etc.).

Some of the active substances and/or other ingredients of the biocidal products are classified as harmful, toxic or very toxic to aquatic life and/or may cause long lasting effects according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances (CLP Regulation). Some substances could pose an unacceptable risk when released to the environment. If the risk assessment for disinfectant products results in an unacceptable environmental risk to aquatic or soil organisms, or to biological STP (PEC/PNEC > 1), or biota (non-target organisms) these biocidal products may only be authorised if the risk can be reduced to an acceptable level by RMM (conditional authorisation).

In a study on behalf of the German Federal Environment Agency the existing environmental RMM for disinfectants (PT 1-5) proposed by different stakeholders were compiled and combined to a set of different RMM that the authorities can choose from during the product authorisation process, depending on identified risks. The different

RMM for PT 3 are compiled in the annex of this document. Considering the progress of the review programme for existing active substances, this paper outlines a common approach for products authorisations and mutual recognitions.




Disinfectants used for veterinary hygiene purposes (PT 3) are an important tool to control animal pathogens in animal housing and transport, prevent animal diseases, increase production and improve the quality of animal products (ESD PT 3 European Commission 2011). Authorities have developed legal requirements on the application of approved disinfection measures to be applied in the case of outbreaks of certain animal/livestock diseases.

The use of disinfectants for professional uses should be integrated in good housekeeping principles as described e.g. in the BREF on “Rearing of Poultry and Pigs” (July 2003). This is not applicable for private uses. Environmental aspects of manure and slurry are mainly been discussed in the context of nutrients spread to fields. The principles of “Good Agricultural Practices” (GAP) should be followed when manure is used as organic fertilizer.

Several active substances may be rapidly degraded after release to manure. Degradation during the storage time of liquid manure may be considered as RMM if supported by available hard data. Other active substances or additives may be toxic and/or may cause long lasting effects.


The development of (cross-) resistance of microorganisms to disinfectants has been observed both after correct use and especially after misuse of disinfectants. Resistance development may be prevented or reduced by the avoidance of application faults and of sublethal concentrations of the active substances as well as by the use of alternative substances. The development of resistance may lead to the need of higher concentrations or an increased frequency of use and thus to higher emissions. The development of cross-resistance of microorganisms to antibiotics following use and misuse of disinfectants is controversially discussed among hygienists.

32

RMM can refer to different addressees such as the industrial formulator, the supplier and distributer, the user of disinfectants, and authorities involved in the surveillance of good practices.



Specific RMM result from the risk assessment and are suitable for a quantitative reduction of the exposure through modification of the respective emission scenarios. Note that RMM for users have to be clearly communicated with the label or product leaflets. Specific RMM are designed to reduce an identified environmental risk (PEC/PNEC > 1) to an acceptable level. The efficiency and practicability of specific RMM has to be proven by the applicant for authorisation of a biocidal product by submitting hard data or studies. Some RMM might also be appropriate if the risk quotient shows a level of concern (e.g. PEC/PNEC > 0.1). T Some RMM might also be appropriate if the risk quotient shows a level of concern (e.g. PEC/PNEC > 0.1). This may e.g. be the case if a substance is used in different PT simultaneously. Specific RMM should be considered in the revision of Emission Scenario Documents (ESDs) as far as possible in order to harmonise the approach. If they represent the way the product is commonly applied the efficiency of the RMM could be quantified.


Category of users

Disinfectants for veterinary hygiene purposes are mainly intended for professional use according to the ESD PT 3 (2011). Professional users such as farmers apply disinfectants in the course of their professional activities. Consumer use of PT 3 disinfectants comprise products used for hygiene purposes of pets.

The benefits of consumer use of disinfectants is controversially discussed among hygienists who argue that untrained consumer often do not apply disinfectants effectively. With respect to RMM for consumer uses of disinfectants only short and simple instructions are likely to be implemented by the user. Thus, emphasis should be on product integrated RMM under the control of the supplier (chemical composition and design). The product label should communicate all instructions on safe use, storage and

33

disposal to consumers. These instructions are mainly attributed to general RMM which cannot be quantitatively assessed.

For certain disinfection activities and/or the use of active substances, which are very toxic, toxic or which may cause long lasting effects the use may be restricted to specifically trained and certified professional users. The same applies to certain modes of applications such as fumigation.

Generally, to exclude consumer uses of PT 3 disinfectants intended for professional use these must not be offered in open shelves or internet commerce through self service.

Area of use

Disinfectants used for veterinary hygiene may specifically be designed for the disinfection of floor, walls and ceiling of stables and vehicles, container and cages for animal transport and animal housing, thus excluding other uses. Other disinfectants are used for the disinfection of animals’ feet (especially hooves of dairy cows) or as non-medicinal teat dips. The area of use will mainly be derived from the intended uses indicated by the applicant which have to be supported by efficacy testing but may be restricted when risks are identified. Specific provisions on the area of use could be combined with other provisions, in particular with those on the category of users and on the product design.


The practicability of RMM concerning the area of use depends on the unambiguous description of allowed uses, but any misuse may not be prevented. Because the intended uses determine the emission scenarios to be assessed, these RMM may be considered in quantitative terms.

Composition

The composition of a disinfectant product is under the control of the formulator and immediately has an influence on potential risks to the environment. All products with ingredients which have been classified in environmental risk phrases (H400, H410-H413) according to the CLP Regulation should be evaluated for possible risks and potential substitutes. The possible formation of DBPs should also be considered.

Formulation

PT 3 disinfectants are usually applied by spraying, aerosol treatment (fogging, misting), foaming, fumigation, brushing, or dipping. For disinfection of footwear workers walk over a mat soaked with a disinfectant or walk through a tub containing the disinfectant.

In certain circumstances, the formulation of the product may help to reduce the risk for the environment through accurate dosage and avoidance of spillages.


34



The packaging of the product also plays a role and can be used to reduce environmental exposure by avoidance of overdosage and disposal of unused product. Product designs supporting the application of disinfectants through accurate dosing e.g. via dosing pumps should be preferred. Therefore, where appropriate, the placing on the market should be restricted to certain specific product design.



The main emission pathways for PT 3 disinfectants are to manure/slurry, air and agricultural soil from spreading of manure/slurry) or to sewage water treatment plant (STP). Manure/slurry is usually stored for some months and might be anaerobically pre-treated before spreading to fields. The elimination of disinfectants during pre-treatment might be considered in the risk assessment if supported by available hard data.

Obligatory discharge of the wastewater from the disinfection of vehicles used for animal transport or from milking parlours to a well-functioning municipal STP might be considered as a RMM. Note, that the proportion of the population connected to urban wastewater treatment within Europe shows considerable differences (between ca. 30% and 95%).9


Labelling

Article 69 (1) of the Biocidal Products Regulation (EU) No 528/2012 stipulates that biocidal products shall be labelled in accordance with the provisions of Directive 1999/45/EC relating to the classification, packaging and labelling of dangerous preparations, now amended by Regulation (EC) No 1272/2008. However the requirements of these legislations may not allow a sufficient description of the special risks which may arise during the use of disinfectants. Therefore, additionally standard phrases should allow a sufficient description of the special risks and of the safety precautions to be taken10. Thus, in addition to the elements already listed in Article 20(3), product labels or the packaging of disinfectants should show the safety precautions for the protection of humans, animals or the environment. These safety precautions should always be carried on the label of the products or on an accompanying leaflet together with the other directions for use and disposal of the product. Reference only to an internet source is not sufficient.9 http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Water_statistics10 This is by analogy to what has been done in the PPP area where standard phrases for special risks and safety precautions

for plant-protection products have been established..35


The careful use of disinfectants is essential to minimise risks for human health and the environment. In many application areas for disinfectants good and best practice documents and training courses have been developed. Maintaining good hygiene practice and good housekeeping is a prerequisite for disinfectants being effective. Hygienic design of the equipment and the facility helps minimising the amount of disinfectant. Several good and best practice documents cover the veterinary hygiene area. Some non-exclusive examples are:

Strauch, D., Böhm, R. 2002. Reinigung und Desinfektion in der Nutztierhaltung und Veredelungswirtschaft. Enke-Verlag Stuttgart

Linton, A. H., Hugo, W. B., Russell, A. D. 1997. Disinfection in veterinary and farm animal practice. Blackwell Science Ltd

Caveney, L., Jones, B., Ellis, K. 2011. Veterinary Infection Prevention and Control. John Wiley & Sons, Chichester,

Fraise, A. P., Lambert, P. A., Maillard, J. Y 2003. Russell, Hugo and Ayliffe's Principles and Practice of Disinfection, Preservation & Sterlization. Blackwell Publishers

Bodenschatz, W. 2012. Desinfektion - Rechtsvorschriften, Richtlinien des Robert Koch-Instituts: Desinfektion, Sterilisation, Reinigung, Schädlingsbekämpfung, Infektionsprävention. Loose page collection B. Behr's Verlag Hamburg

Böhm, R,. Strauch, D. 1996. Desinfektion im Stall - weniger Krankheiten, mehr Leistung. Auswertungs- und Informationsdienst für Ernährung, Landwirtschaft und Forsten (ADI) Band 1163

European Association of Zoo and Wildlife Veterinarians (EAZWV) 2010.Transmissible Diseases Handbook (4th Ed.) Chapter VIII. Guidelines for cleaning and disinfection in zoological gardens. Infectious Diseases Working Group (IDWG) http://www.eaza.net/activities/Pages/Transmissible%20Diseases%20Handbook.aspx

The Best Available Technique Reference Document (BREF) for intensive rearing of poultry and pigs (July 2003)11 states that regular cleaning and disinfection of the housing equipment and all the housing surfaces after removal of all the livestock is necessary but does not specifically refer to the selection and use of cleaning and disinfection agents. The main environmental impacts of farming result from the manure from the animals and poor landspreading management or techniques. Good housekeeping and improved farm, manure and nutrient management may also help reducing emissions from the use of disinfectants. In the revision of the BREF, initiated in 2009, it is envisaged to identify good agricultural practices for intensive rearing of poultry and pigs.


RMM referring to codes of good practice may only be considered in quantitative terms in the exposure assessment if these good practices are well established in professional use of disinfectants and if some surveillance by authorities is carried out. The practicability

11 http://eippcb.jrc.es/reference/BREF/irpp_bref_0703.pdf36

of these RMM is not under the control of the authorisation process for disinfectants. RMM regarding good practices do not apply for consumer uses of disinfectants.12


Annex I


General RMM


Take care for general good housekeeping and good agricultural practice.





Precleaning of surfaces required before using disinfectants.





Specific RMM




1 Category of user

W, G, S, STP Only professional uses are allowed. PT3 disinfectants are mainly designed for professional uses but there exist also consumer uses in the context of the housing of pets. To exclude private uses do not offer in open shelves or other forms of self service.

2 W, G, S, STP Application only by professional user with certificate of competence for [fumigation operations].

3 Area of use W, G, S, STP Only use organic peracids or inorganic peroxides in water protective areas. RMM from the Bavarian state office for water management on water protection after disinfection measures during the outbreak of the avian



influenza.

4 Composition W, G, S, STP The following additives [add the additives such as detergents, complexing agents] should be ultimately biological degradable in accordance with [add e.g. Regulation (EC) No. 648/2004 on detergents].


5 W, G, S, STP The following additives [add the additives] should be eliminated by 80% of the dissolved organic carbon (DOC) or of the chemical oxygen demand (COD) in the [add the test method, e.g. Zahn-Wellens test according to EN 9888].



7 Formulation W, G, S, STP Use automatic dosage equipment instead of manual mixing and loading. Accurate dosage helps avoiding misapplication and reducing the volume of the working solution and of the amount used and discharged.

8 Treatment W, G, S, STP To protect soil organisms and water living organisms, residues containing Prevention of direct

40



and/or disposal the product need to be removed to the manure deposit. emission to soil and water under the presumption that the risk via manure emission is acceptable


W, G, S, STP To protect soil organisms and water living organisms, the [foot bath] should be located on a hard standing and residues containing the product need to be removed to the manure deposit.

Prevention of direct emission to soil and water under the presumption that the risk via manure emission is acceptable

10 S, G Before spreading slurry (manure) from treated animals it has to be stored for at least x day/months.

RMM only applicable if the storage time corresponds to that required for nutrient management according to good agricultural practice and some surveillance exist.

11 W, G, S, STP After use of [e.g. teat dips, boot baths] residues must be collected and disposed of separately.

RMM for avoiding emissions from certain applications where releases to manure or STP are not acceptable. The practicability of this RMM must be supported e.g. by

41



recollection systems established by the supplier.

12 W, G, STP To prevent the inhibition in functioning of an on-site wastewater treatment system and to protect aquatic organisms, possible residues containing the product must be discharged to [the manure deposit or a municipal STP].


13 W, G, STP To protect in water living organisms, prevent that residues containing the product enter the sewer and apply the following safety measures: ["…"].



W, G, S, STP All waste water must be treated in an on-site or municipal wastewater treatment plant that incorporates both primary and secondary treatments.

or

Onsite pre-treatment required by [suitable techniques] with a removal efficiency of [expression of threshold or %] before discharging into sewer.

or

Neutralisation or inactivation [is normally] required before discharge into [sewage system / into water treatment plants].

Specify conditions and measures related to the onsite or municipal sewage treatment plant if appropriate (e.g. biological treatment, neutralization, minimum grade of elimination). To be justified with hard data and evaluated in the risk assessment.

15 W, G A storm water management plan is needed to ensure that the wastewater treatment plant is not overloaded with uncontaminated water.

Avoidance of a STP-bypass of contaminated water through storm water. Only practicable for Member

42



states which have developed storm-water provisions.


The minimum grade of elimination in the sewage plant required is (X %)

To be proven with hard data and evaluated in the risk assessment.




W, G, S To protect [water living organisms, groundwater and soil organisms], application of this product is restricted to areas with a hard standing. Spills and residues containing the product need to be discharged to the sewer [with connection to a STP].


19 W, S, STP To protect water living organisms and micro-organisms in the STP, it is not permitted discharge spills and residues containing the product to surface water or to the sewer.

RMM for industry and other professional institutes where in practice the product is collected and disposed after use.

20 W, S, STP To protect water living organisms, the product may not be authorised for uses in animal housings where emission to a STP or direct emission to surface water cannot be prevented,

RMM referring to application in animal houses (poultry houses) where during the cleaning

43



procedure with high-pressure cleaning equipment a fraction of the applied biocidal product can be released to waste water that is discharged to a STP.

21 W, G, STP Transfer of process wastes to manure storage containers required Intermediate storage of wastewater containing disinfectants may also inactivate the active ingredients. Removal efficiency to be proven by hard data.


W, G, S, STP Ensure all waste water is collected and treated via a STP.

or


or


Obligatory connection of the sewer to a well-functioning municipal STP.

44





24 STP Prevent adverse effects on municipal sewage treatment by limiting [concentration in waste water to ….. mg/l, load in waste water to … kg/d].

Risk based evaluation of the maximum amount allowed to be used. RMM to be derived from the risk assessment only practicable if enforcement is monitored by authorities.

25 W, G, S, STP If the concentration of [add name of active substance] in the [sewer system] [inlet of the STP] exceeds the maximum allowable concentration of [indicate limit concentration] collect the disinfectant and dispose them as hazardous waste.

Risk based decision of the disposal of working solutions

RMM to be derived from the risk assessment only practicable if enforcement is monitored by authorities.


STP Avoid peak loads through continuous discharge to the wastewater. RMM for the protection of the activated sludge organisms to be proven by

45



hard data. May be concluded in wastewater permits. Only practicable if enforcement is monitored by authorities.

27 A Limit emission to [air] by [technique] with an efficiency of not less than [efficiency rate]. The filtered/scrubbed/absorbed/precipitated substance should/can be […].

RMM derived from the risk assessment to be proven by hard data.

28 PSP Take the necessary precautions to prevent exposure of [bats] and other protected animals in [the gassed areas / spaces / structures / buildings].


29 W, G, STP Dry cleaning of containers and equipment and disposal via solid waste in order to minimize releases to water.

or



30 W, G Avoid the use of halogenated oxidising biocides, except where the To be applied where

46



alternatives are not effective. halogenated oxidizing biocides are used.



W, G, S, STP Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans.

RMM from the Bavarian state office for water management on water protection after disinfection measures during the outbreak of the avian influenza.

33 W, G, S, STP Discharge used working solutions to municipal STP or to the liquid manure tank or collect and transport them to STP via tank trucks.

34 W, G, S, STP The discharge to small STP below 50 inhabitant equivalents is not allowed

47

ENVIRONMENTAL RISK MITIGATION MEASURES FOR FOOD AND FEED AREA DISINFECTANTS (PT 4)


This Guidance document describes Risk Mitigation Measures (RMM) for food and feed area disinfectants (PT 4) to be considered during the authorisation of biocidal products as well as the evaluation of active substances, especially if an environmental risk is identified. PT 4 disinfectants cover the food, drink and milk industries, slaughterhouses and butcheries, large scale catering kitchens and canteens as well as milking parlour systems (see Emission Scenario Document for PT 4 (European Commission 2011). Dishwashing products intended to have a biocidal effect and disinfecting detergents intended for surfaces where food or feed is produced, placed, stored or offered for consumption are attributed to PT 4 and also cover consumer uses according to the Manual of Decisions.13

The main emission route to the environment for PT 4 disinfectants are municipal sewage treatment plants (STP) and surface water as well as soil and sediment (either through direct discharges after on-site wastewater treatment or from the outflow of STPs).


In a study on behalf of the German Federal Environment Agency the existing environmental RMM for disinfectants (PT 1-5) proposed by different stakeholders were compiled and combined to a set of different RMM that the authorities can choose from during the product authorisation process, depending on identified risks. The different RMM for PT 4 are compiled in the annex of this document. Considering the progress of the review programme for existing active substances, this paper outlines a common approach for products authorisations and mutual recognitions.



13 https://circabc.europa.eu/sd/d/fa19127f-39e2-4ab2-9676-77b9a8a06c65/MoD_21_12_11.pdf


Disinfectants used for the food and feed area (PT 4) are an important tool for maintaining hygiene conditions and for infection control by preventing microbiological pathogens. The use of disinfectants for professional uses is usually integrated in a general concept for good hygiene practice such as the “Hazard Analysis and Critical Control Points” (HACCP) which is referred to in European legislation such as Regulations (EC) No 852/2004 and 853/2004 on the hygiene of foodstuffs. However, this is not applicable for private uses.

Several active substances may be rapidly degraded by chemical-physical processes during application or biodegraded in STPs. Other active substances or additives may be toxic and/or may cause long lasting effects. As STPs are important intermediate compartments for PT 4 disinfectants they need to be protected from substances inhibitory to the activated sludge organisms.

In addition, disinfectants may also be directly discharged to surface water depending on the capacity of the on-site wastewater (pre)treatment plant and/or the connection to a sewer discharging to municipal STPs. Another source for direct discharges is the storm water overflow of STPs. In small farms without connection to the sewer system wastewater from milking parlours may also be discharged to the manure and subsequently to the soil.


The development of (cross-) resistance of microorganisms to disinfectants has been observed both after correct use and especially after misuse of disinfectants. Resistance development may be prevented or reduced by the avoidance of application faults and of sublethal concentrations of the active substances as well as by the use of alternative substances or methods. The development of resistance may lead to the use of higher concentrations or an increased frequency of use and thus to higher emissions. The development of cross-resistance of microorganisms to antibiotics following use and misuse of disinfectants is controversially discussed among hygienists.

RMM can refer to different addressees such as the industrial formulator, the supplier and distributer, the user of disinfectants, and authorities involved in the surveillance of good practices.


General RMM (e.g. general precautionary advice, best available techniques, good housekeeping, applying hygiene management systems) should be applied to all products, independent from the results of the risk assessment, if applicable and exemplify a way for the sustainable use of the disinfectants. This reflects the BPR that requires a proper use of the biocidal products. This use shall also involve the rational application of a

49

combination of physical, biological, chemical or other measures as appropriate, whereby the use of biocidal products should be limited to the minimum necessary (Art. 3(7)). They describe reasonable conditions of use and reflect common sense. The intention is to avoid misapplication of disinfectants. However, general RMM cannot be used in the environmental exposure assessment in quantitative terms, because the effect on the emissions and the compliance cannot be proven.



Category of users

Disinfectants for the food and feed area are principally intended for professional and industrial use according to the ESD PT 4 (2011). Professional user are persons who use disinfectants in the course of their professional activities, including operators, technicians, employers and self-employed people in slaughterhouses and butcheries as well as in large scale kitchens and canteens. Industrial user apply disinfectants in the food, drink, and milk industries. For certain disinfection activities and/or the use of active substances, which are very toxic, toxic or which may cause long lasting effects the use may be restricted to specifically trained and certified professional users, in accordance with the HACCP principles. The same applies to certain modes of applications such as fumigation.

The benefit of disinfectants in private home kitchens is controversially discussed among hygienists who argue that untrained consumer often do not apply disinfectants effectively. RMM for consumer uses of disinfectants only short and simple instructions are likely to be implemented by the user. Thus, emphasis should be on product integrated RMM under the control of the supplier (chemical composition and design). The product label should communicate all instructions on safe use, storage and disposal to consumers. These instructions are mainly attributed to general RMM which cannot be quantitatively assessed.

Generally, to exclude non-professional (consumer) uses of PT 4 disinfectants these must not be offered in open shelves or internet commerce through self service.

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Area of use

Disinfectants used in the food and feed area may specifically be designed for the disinfection of the equipment, containers, surfaces or the pipework associated with the production, transport, storage or consumption of food, feed or drink, thus excluding other uses. Disinfection of pipes is performed by “cleaning in place” (CIP) where the disinfectants are added to the circulating water. The area of use will mainly be derived from the intended uses indicated by the applicant which have to be supported by efficacy testing but may be restricted when risks are identified. Specific provisions on the area of use could be combined with other provisions, in particular with those on the category of users and on the product design.


The practicability of RMM concerning the area of use depends on the unambiguous description of allowed uses but any misuse may not be prevented. Because the intended uses determine the emission scenarios to be assessed, these RMM may be considered in quantitative terms.

Composition

The composition of a disinfectant product is under the control of the formulator and immediately has an influence on potential risks to the environment. All products with ingredients which have been classified in environmental risk phrases (H400, H410-H413) according to the CLP Regulation should be evaluated for possible risks and potential substitutes. The possible formation of DBPs should also be considered.

Formulation

PT 4 disinfectants are usually applied by spraying, foaming, soaking, brushing or direct addition to pipes, vessels and other process equipment. Often the working solutions are made up from concentrates via automatic dosing pumps. In certain circumstances, the formulation of the product may help to reduce the risk for the environment through accurate dosage and avoidance of spillages.




The packaging of the product also plays a role and can be used to reduce environmental exposure by avoidance of overdosage. Product designs supporting the application of disinfectants through accurate dosing e.g. via dosing pumps should be preferred. Therefore, where appropriate, the placing on the market should be restricted to certain specific product design.

51



The main emission pathway for PT 4 disinfectants is via the sewer system either to an on-site STP or to a municipal STP. Avoidance of peak loads discharged to biological treatment plants or neutralisation of the active substance are RMM for reducing acute toxicity to activated sludge or to anaerobic micro-organisms.

Obligatory discharge of the wastewater to a well-functioning municipal STP might be considered as a RMM. Note, that the proportion of the population connected to urban wastewater treatment within Europe shows considerable differences (between ca. 30% and 95%).14 If no STP is existent in a community it can be expected that direct releases of wastewater from the food and feed area including disinfectants to surface water is very likely.


Labelling



The careful use of disinfectants is essential to minimise risks for human health and the environment. In many application areas for disinfectants good and best practice documents and training courses have been developed. Maintaining good hygiene practice and good housekeeping is a prerequisite for disinfectants being effective. Hygienic design of the equipment and the facility helps minimising the amount of disinfectant. Several good and best practice documents cover the food and feed area. Some non-exclusive examples are:

14 http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Water_statistics15 This is by analogy to what has been done in the PPP area where standard phrases for special risks and safety precautions

for plant-protection products have been established..52

DIN EN 1672-2 (7/2009): Food processing machinery - Basic concepts - Part 2: Hygiene requirements

FAO/WHO (1999): The Codex Alimentarius – Recommended international code of practice – General principles of food hygiene. http://www.fao.org/docrep/005/Y1579E/y1579e02.htm

Arvanitoyannis, I. S. (2008): Waste management for the food industries. Elsevier Academic Press, Amsterdam

Stanga, M. (2010): Sanitation - Cleaning and Disinfection in the Food Industry. Wiley-VCH, Weinheim

Lelieveld, H. L. M. Mostert M. A., Holah. J. (Ed. 2005): Handbook of hygiene control in the food industry. Woodhead Publishing Ltd and CRC Press LLC

Reiche, T. (2012): Hygiene in Großküchen. Loose-leaf edition, Behr's Verlag, Hamburg

The Best Available Technique Reference Document (BREF) on food, drink and milk industries (August 2006) states that “the selection and use of cleaning and disinfection agents must ensure effective hygiene control but with due consideration of environmental implications.” The BREF refers to the optimisation of operational processes for minimising the quantity of the cleaning and disinfection agents used (e.g. recirculating of cleaning solutions). The BREF on slaughterhouses and animals by-products industries (May 2005) includes a chapter with recommendations to avoid and reduce the use of cleaning and disinfection agents containing active chlorine in order to reduce emissions of DBP (organic halogens, chlorinated hydrocarbons) to water. National legislations on wastewater discharges often provide requirements which have an impact on the selection of PT 4 disinfectants. For example, the German Wastewater Ordinance defines limit values of the AOX concentration and thus restricts the use of organically bonded halogen compounds or halogen-releasing substances. The formation of DBP could partly be managed by avoidance and/or removal of the inorganic or organic precursors.




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http://www.fao.org/docrep/005/Y1579E/y1579e02.htm

Annex I


General RMM


Take care for general good hygiene and housekeeping.




A retention period of the disinfectant working solution of [x] days leads to considerably less contaminated wastewater compared to working solutions which are changed every day.

Precleaning of surfaces required before using disinfectants.





Specific RMM

Depending on the origin of the identified unacceptable risks suitable RMM can be chosen from this list of standardised RMM phrases. The following abbreviations are used: W: Water, G: Groundwater, S: Soil, A: Air, STP: Sewage Treatment plant, PSP: Primary and Secondary Poisoning . Italic words written in brackets should be adapted on the respectively application of the biocidal product. They have only replacement character and illustrate proposals.



1 Category of users

W, G, S, STP Only professional uses are allowed.

or

Applications only by professional user with expert knowledge e.g. for fumigation operations.

PT4 disinfectants are designed for professional uses. To exclude private uses do not offer in open shelves or other forms of self service.

2 W, G, S, STP Application only by professional user with certificate of competence for fumigation operations.

3 Area of use W, G, S, STP To protect [water living organisms / activated sludge organisms] only use in CIP-treatment when recirculation of the cleaning solution for minimising releases to wastewater is applied.

Restriction of permanent use in order to minimize the overall load to sewage treatment plants.

4 Composition W, G, S The following additives [add the additives such as detergents, complexing agents] should be ultimately biological degradable in accordance with [add e.g. Regulation (EC) No. 648/2004 on detergents].


5 W, G, S The following additives [add the additives] should be eliminated by 80% RMM referring to the



of the dissolved organic carbon (DOC) or of the chemical oxygen demand (COD) in the [add the test method, e.g. Zahn-Wellens test according to EN 9888].

product formulation with certain requirements concerning the treatability of additives in STP.



Minimisation of the overall load through accurate dosage and avoidance of accidents.


8 W, G, S, STP Provide in small packages only. RMM directed to the formulator, small packages may help reducing consumption and disposal.

10 Formulation W, G, S STP Use automatic dosage equipment instead of manual mixing and loading. Accurate dosage helps

56



avoiding misapplication and reducing the volume of the working solution and of the amount used and discharged.


W, G, S, STP To protect in water living organisms, prevent that residues containing the product enter the sewer and apply the following safety measures: ["…"].



W, G, S, STP All waste water must be processed in an industrial or municipal wastewater treatment plant that incorporates both primary and secondary treatments.

or

Onsite pre-treatment required by [suitable techniques] with a removal efficiency of [expression of threshold or %] before discharging into sewer.

Neutralization or inactivation [is normally] required before discharge into [sewage system / into water treatment plants].

Specify conditions and measures related to the onsite or municipal sewage treatment plant if appropriate (e.g. biological treatment, neutralization, minimum grade of elimination). To be justified with sound data and evaluated in the risk assessment.

13 W, G A storm water management plan is needed to ensure that the wastewater treatment plant is not overloaded with uncontaminated water.

Avoidance of a STP-bypass of contaminated water

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through storm water. Only practicable for Member states which have developed storm-water provisions.


The minimum grade of elimination in the sewage plant required is [ x %].

To be proven with sound data and evaluated in the risk assessment.




W, G, S To protect [water living organisms, groundwater and soil organisms], application of this product is restricted to areas with a hard standing. Spills and residues containing the product need to be discharged to the sewer [with connection to a STP].


17 W, G STP To prevent the inhibition in functioning of an on-site wastewater treatment system and to protect aquatic organisms, possible residues containing the product must be discharged to [the manure deposit or] a municipal STP.


18 W, S, STP To protect water living organisms and micro-organisms in the STP, it is not permitted discharge spills and residues containing the product to surface water or the sewer.

RMM for industry and other professional institutes where in practice the product is collected and disposed after

58



use.

19 W, G To protect water living organisms, residues containing the product should be discharged to the sewer connected to the STP. For disinfection of surfaces >2000 m2, the sewer connection of that facilities must be preceded by a sediment grease separation tank conform EN 1825-1 and 2.

Removal efficiency to be proven by sound data.

20 W, G, STP Transfer of process wastes to storage containers.

or

A retention period of the disinfectant working solution of x days leads to considerably less contaminated wastewater compared to working solutions which are changed every day.

Intermediate storage of wastewater until the disinfection agents are inactivated. Removal efficiency to be proven by sound data.


W, G, STP Limit release rate to waste water to (kg/day): Minimization of amount used through recycling of cleaning solution. RMM to be considered in wastewater permits and inspected by authorities. Only practicable if enforcement can be monitored.

22 To protect water living organisms only use in CIP-treatment when recirculation of the cleaning solution for minimizing releases to wastewater is applied.

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23 W, G, S, STP Ensure all waste water is collected and treated via a STP.

or


or


Obligatory connection of the sewer to a well-functioning municipal STP.



25 STP Prevent adverse effects on municipal sewage treatment by limiting [concentration in waste water to ….. mg/l] [load in waste water to … kg/d].

Risk based evaluation of the maximum amount allowed to be used. RMM to be derived from the risk assessment only practicable if enforcement is monitored by authorities.

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W, G, S, STP If the concentration of [add name of active substance] in the [sewer system] [inlet of the STP] exceeds the maximum allowable concentration of [indicate limit concentration] collect the disinfectant and dispose them as hazardous waste.

Risk based decision of the disposal of working solutions


27 W, G, S, STP If concentrations of [add name of active substance] in the sewer system exceed maximum allowable concentration of [indicate limit concentration] neutralize [e.g. glutaraldehyde with glycine, chlorine with sodium bisulfite].

Treatment of the working solutions. RMM to be proven by sound data, generation of disinfection by-products to be evaluated.

28 STP Avoid peak loads through continuous discharge to the wastewater. RMM for the protection of the activated sludge organisms to be proven by sound data. May be concluded in wastewater permits. Only practicable if enforcement is monitored by authorities.

29 A Limit emission to [air] by [technique] with an efficiency of not less than [efficiency rate]. The filtered/scrubbed/absorbed/precipitated substance should/can be […].


61



30 PSP Take the necessary precautions to prevent exposure of bats and other protected animals in the gassed areas / spaces / structures / buildings.



W, G, S, STP Use a sampling system for determining environmental exposure. RMM only practicable if results from monitoring triggers the use of a disinfectant. Also to be used as a control for the efficiency of an on-site treatment plant.

32 W, G, STP Dry cleaning of containers and equipment and disposal via solid waste in order to minimize releases to water.

or



33 W, G Avoid the use of halogenated oxidising biocides, except where the alternatives are not effective.

or

In order to achieve efficacy and to minimize the formation of disinfection by-products (DBP) remove total organic carbon (TOC) and other precursor

Substitution of halogenated oxidizing biocides is recommended in BREFS.

To be applied where halogenated oxidizing

62



compounds prior to adding the disinfectant. biocides are used.


35 W, G, S, STP To protect soil organisms and water living organisms, residues containing the product need to be removed to the manure deposit.

Prevention direct emission to soil and water from farms under the presumption that the risk via manure emission is acceptable.

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ENVIRONMENTAL RISK MITIGATION MEASURES FOR DRINKING WATER DISINFECTANTS (PT 5)


This Guidance document describes Risk Mitigation Measures (RMM) for drinking water disinfectants to be considered during the authorisation of biocidal products as well as the evaluation of active substances, especially if an environmental risk is identified. PT 5 disinfectants cover products used by professional user as well as by consumer within their outdoor activities. Drinking water disinfectants must comply with specific national and European quality standards set up for water intended for human consumption. The main types of disinfection processes are primary disinfection (main purpose is to kill the majority of microorganisms), residual disinfection (maintenance of an anti-microbial potential in the distribution system), and stand-by disinfection (high dosage-application to clean up a contaminated system or when taking a new system into use). Most of the disinfectants applied have an oxidizing property and are not stable. Non-oxidative biocides such as silver salts are used for smaller case applications such as mobile water tanks (Emission Scenario Document (ESD) for PT 5, European Commission 2003).

The Drinking water Directive 98/83/EC requires Member States to ensure that, where disinfection forms part of the preparation or distribution of water intended for human consumption, the efficiency of the disinfection treatment applied is verified. Thus, also before the implementation of BPR most Member States have implemented approval schemes for drinking water disinfectants. There are relatively few active substances applied, among them chlorine, chlorine dioxide, sodium hypochlorite, and hydrogen peroxide. On a small scale also silver salts, dichloroisocyanurates, potassium permanganate, and iodine are applied.

In contaminated distribution equipment also shock treatments with higher dosages of disinfectants (e.g. 10 fold of standard concentration) are required to clean the pipes. In this case any wastewater generated should be evaluated and treated, as appropriate, e.g. by inactivation of chlorine with sodium thiosulfate

The main emission route of drinking water disinfectants is to the sewer system and municipal sewage treatment plants (STP).


In a study on behalf of the German Federal Environment Agency the existing environmental RMM for disinfectants (PT 1-5) proposed by different stakeholders were compiled and combined to a set of different RMM that the authorities can choose from during the product authorisation process, depending on identified risks. The different RMM for PT 5 are compiled in the annex of this document. Considering the progress of

the review programme for existing active substances, this paper outlines a common approach for products authorisations and mutual recognitions.




Drinking water disinfectants are an important tool for maintaining the hygienic quality of water intended for human consumption. The use of disinfectants should always be integrated in a general water safety plan which includes all steps of water supply from the protection of the catchment area to the distribution system. Drinking water processing consists in physical-chemical removal processes (e.g. coagulation, sedimentation, precipitation, filtration) combined with chemical disinfection, if required.

Drinking water disinfectants generated in-situ (ozone, chlorine from electrolytic processes, ultra-violet radiation) were not covered by the former Biocidal Product Dirctive (BPD) but will be assessed under the new BPR, including possible risks from the precursor(s).

Most active substances have oxidation properties and are rapidly eliminated during application. It is common practice, to reduce the residual chlorine level to a specific concentration before the water enters the distribution system by addition of sulfur dioxide or sulfite compounds (dechlorination). During application a part of the oxidative active substances reacts to disinfection by-products (DBP) with inorganic or organic matter present in water. Many DBPs are harmful and may pose a risk to the environment and/or form persistent organic compounds and adsorbable organic halogens (AOX) which also rise environmental concern. Directive 98/83/EC on the quality of water intended for human consumption requires Member States to take all measures necessary to ensure that any contamination from disinfection by-products is kept as low as possible without compromising the disinfection. The maximum concentration of Trihalomethane DBPs in drinking water is 100 μg/l (total) and that of Bromate is 10 µg/l, but Member States are asked to strive for lower values, where possible without compromising the disinfection. A background document on the assessment of DBP is being developed by CAs where it is inter alia proposed to carry out PEC/PNEC-assessments of DBP based on monitoring data from the biocide uses subjected to authorisation. The results of these risks assessments should be taken into account when considering RMM for the respective products.

There are several proposals for efficacy testing of drinking water disinfectants17. While the inherent resistance (susceptibility) of microorganisms and specific pathogens to drinking water disinfectants has broadly been analysed, the development of acquired resistance of microorganisms through the use of drinking water disinfectants has

17 http://www.umweltbundesamt.de/wasser-e/themen/downloads/trinkwasser/drinking_water_disinfectants.pdf

65

received far less attention. Some publications suggest that the same mechanisms of resistance development occur.18 Resistance development is mainly discussed in the context of factors such as corrosion, dead-end pipes, organic matter, and biofilm development all supporting the attachment of microorganisms to surfaces and preventing their susceptibility to disinfectants.

Resistance development may be prevented or reduced by the avoidance of application faults and of sublethal concentrations of the active substances as well as by the use of alternative substances.

RMM can refer to different addresses such as the industrial formulator, the supplier and distributor, the user of disinfectants, and authorities involved in the surveillance of good practices.





Category of users

18 e.g. Shrivastava R et al. 2004. Suboptimal chlorine treatment of drinking water leads to selection of multidrug-resistant Pseudomonas aeruginosa. Ecotoxicol Environ Saf. 58(2):277-283

66

Drinking water disinfectants are mainly applied by specifically trained professional user such as drinking water operators. On a smaller scale privately owned treatment plants for outlying settlements exist next to mobile drinking water tanks from outdoor activities.

The benefits of consumer use of PT 5 disinfectants should carefully be compared with the feasibility of non-chemical treatment techniques. With respect to RMM for consumer uses of disinfectants only short and simple instructions are likely to be implemented by the user. Thus, emphasis should be on product integrated RMM under the control of the supplier (chemical composition and design). The product label should communicate all instructions on safe use, storage and disposal to consumers. These instructions are mainly attributed to general RMM which cannot be quantitatively assessed.

To exclude non-professional (consumer) uses of PT 5 disinfectants these must not be offered in open shelves or internet commerce through self service.

Area of use

Drinking water disinfectants are mainly applied in public or industrial drinking water abstraction plants but there exist also (very) small water supplies from private owners. Additionally mobile disinfection devices exist for the outdoor sector. The water source often determines the quality of the water. Groundwater sources generally are of superior quality to surface water from rivers and reservoirs and require less treatment. The area of use and the choice of the water source may also contribute to reduce the formation of DBP through the use of some oxidative disinfectants, e. g. by avoiding areas where the inorganic or organic precursors of such DBP are known and present.

The practicability of RMM concerning the area of use depends on the unambiguous description of allowed uses but some misuse may not be prevented. Because the intended uses determine the emission scenarios to be assessed, these RMM may be considered in quantitative terms.

Composition

In most cases the biocidal product is identical to the active substance or its precursor. The possible formation of DBPs should also be considered.

Formulation

PT 5 disinfectants are mainly applied by automatic dosing pumps. In certain circumstances the disinfectant is manually added to a water tank, especially within outdoor activities. Accurate dosage is one factor to prevent risk for the environment and avoid spillages. The possible formation of DBPs should also be considered when evaluating the formulation. Product integrated RMM may be quantitatively considered in the exposure assessment.


The packaging of the product also plays a role and can be used to reduce environmental exposure by avoidance of overdosage and disposal of unused product. Product designs supporting the application of disinfectants through accurate dosing e.g. via dosing pumps should be preferred. Therefore, where appropriate, the placing on the market should be restricted to certain specific product design.

67



The main emission pathway for PT 5 disinfectants is via the sewer system. The removal of precursor of DBP and disinfection concentrations exceeding the limit values by technical treatment and the removal of DBP before the water enters to the distribution system are possible options for RMM.


Labelling



The careful use of disinfectants is essential to minimise risks for human health and the environment. In many application areas for disinfectants good and best practice documents and training courses have been developed. Maintaining good water processing practices is a prerequisite for disinfectants being effective. The design of the equipment and the facility helps minimising the amount of disinfectant. Several good and best practice documents as well as technical standards cover the processing of drinking water and minimisation of the formation of DBPs. Some non-exclusive examples are:

White, G. C. 2010. White’s handbook of chlorination and alternative disinfectants. 5th Edition, Black & Veatch Corporation, John Wiley & Sons, Hoboken, New Jersey

19 This is by analogy to what has been done in the PPP area where standard phrases for special risks and safety precautions for plant-protection products have been established.

68

Niessner, R., Höll, K. 2010. Wasser Nutzung im Kreislauf: Hygiene, Analyse und Bewertung. 9th edition, De Gruyter, Berlin

Dammers, N. 2011. Towards a Guidance Document for the implementation of a Risk Assessment for small water supplies in the European Union - Overview of best practices. Study of the Watercycle Research Institute on behalf of DG ENV European Commission, November 2011

WHO 2011. Guidelines for Drinking-water Quality - 4th Edition. World Health Organisation, WA 675, Geneva, Switzerland http://whqlibdoc.who.int/publications/2011/9789241548151_eng.pdf

Le Chevallier, M. W., Au, K. K. 2004. Water Treatment and Pathogen Control: Process Efficiency in Achieving Safe Drinking Water. World Health Organization, IWA Publishing, London http://www.who.int/entity/water_sanitation_health/dwq/en/watreatpath.pdf

WHO, OECD. 2003. Assessing microbial safety of drinking water - Improving approaches and methods. IWA-publishing, London http://www.who.int/water_sanitation_health/dwq/9241546301full.pdf

Weinberg, H. S., Krasner, S. W., Richardson, S. D., Thruston, A. D., 2002. The Occurrence of Disinfection By-Products (DBPs) of Health Concern in Drinking Water: Results of a Nationwide DBP Occurrence Study. EPA/600/R-02/068 http://www.epa.gov/athens/publications/reports/EPA_600_R02_068.pdf

US EPA 1999. Alternative Disinfectants and Oxidants Guidance Manual. United States EPA Environmental Protection Agency. EPA 815-R-99-014, April 1999

Borchers, U. 2012. Die Trinkwasserverordnung 2011: Erläuterungen- Änderungen – Rechtstexte. Beuth-Verlag Berlin

The drinking water guideline of the WHO and supporting documents as well as the drinking water guideline of the European Commission are supplemented by national guidelines and lists of approved drinking water disinfectants.20 The formation of DBP could partly be managed by avoidance and/or removal of the inorganic or organic precursors. In addition to product labelling and instructions for use, several good and best practise documents should be made available to the user.


20 e.g. in Germany: http://www.gesetze-im-internet.de/bundesrecht/trinkwv_2001/gesamt.pdf http://www.umweltbundesamt.de/wasser/themen/downloads/trinkwasser/trink11.pdf or in the United Kingdom: http://dwi.defra.gov.uk/drinking-water-products/approved-products/soslistcurrent.pdf.


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http://www.umweltbundesamt.de/wasser/themen/downloads/trinkwasser/trink11.pdf

http://www.epa.gov/athens/publications/reports/EPA_600_R02_068.pdf

http://www.who.int/entity/water_sanitation_health/dwq/en/watreatpath.pdf

http://whqlibdoc.who.int/publications/2011/9789241548151_eng.pdf

Annex I


General RMM


Take care for general good hygiene and good water processing practice.



Examine whether the use of disinfectants can totally or partially be substituted by other (e.g. microfiltration) processes.



Specific RMM

Depending on the origin of the identified unacceptable risks suitable RMM can be chosen from this list of standardized RMM phrases. The following abbreviations are used: W: Water, G: Groundwater, S: Soil, A: Air, STP: Sewage Treatment plant, PSP: Primary and Secondary Poisoning. Italic words written in brackets should be adapted on the respectively application of the biocidal product. They have only replacement character and illustrate proposals.

70



1 Category of users

W, G, S, STP Only professional uses are allowed. Refers to PT 5 disinfectants designed for professional uses. To exclude private uses do not offer in open shelves or other forms of self service.



Minimisation of the overall load through accurate dosage and avoidance of accidents and disposal of the unused product.

3 W, G, S, STP, Ensure that splashes and spills are avoided by product design. RMM directed to the formulator and referring to the product design (apparatus, packaging).

4 Provide in small packages only. RMM directed to the formulator, small packages may help reducing consumption and disposal.

5 Formulation W, G, S Use automatic dosage equipment instead of manual mixing and loading. Accurate dosage helps avoiding misapplication and reducing the volume of the working solution and of the

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amount used and discharged.

6 Formulation W, G Avoid the use of halogenated oxidising biocides, except where the alternatives are not effective.

Substitution of halogenated oxidizing biocides by Ozone, UV radiation or membrane treatment where DBP exceed the limit values.

7 Treatment STP Prevent adverse effects on municipal sewage treatment by limiting [concentration in waste water to ….. mg/l, load in waste water to … kg/d].

Risk based evaluation of the maximum amount allowed to be used.


8 W, G, S, STP If the concentration of [add name of active substance] in the [sewer system, inlet of the STP] exceeds the maximum allowable concentration of [indicate limit concentration] collect the disinfectant and dispose them as hazardous waste.

Risk based decision of the disposal of working solutions.

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9 Treatment W, G, S, STP If concentrations of [add name of active substance] in the sewer system exceed maximum allowable concentration of [indicate limit concentration] neutralize [e.g. chlorine with sodium dioxide or sodium bisulfite].

Removal of oxidative disinfectants exceeding the limit values to be proven by sound data.

Generation of disinfection by-products and neutralization by-products to be evaluated.

10 A Limit emission to [air] by [technique] with an efficiency of not less than [efficiency rate]. The [filtered/scrubbed/absorbed/precipitated substance should/can be …].


11 W, G, STP A wastewater permit must be available before rinsed solutions from shock treatment of the equipment are discharged to [surface water / STPs].

RMM in case of decontamination of the

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equipment.

12 W, G, STP After shock treatments with [e.g. chlorine, potassium dichloroisocyanurate, hydrogen peroxide] collect the rinsed solutions and inactivate them with [e.g. sodium thiosulfate].

RMM in case of decontamination of the equipment.

13 W, G, S, STP Use a sampling system for determining environmental exposure. RMM only practicable if results from monitoring triggers the use of a disinfectant.

14 Treatment W In order to achieve efficacy and to minimize the formation of disinfection by-products (DBP) remove total organic carbon (TOC) and other precursor compounds prior to adding the disinfectant.

RMM for reducing the formation of DBP by pre-treatment of the water source.

15 W Monitor disinfection by-products [e.g. bromate, 1,2 dichloromethane, trihalogenmethanes, bound chlorine, monochloramine, dichloramine, chlorite] and ensure that the limit values [indicate limit values] are

Maintaining quality criteria for DBP in drinking water.

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maintained.

16 W Removing disinfection by-products prior to distribution of drinking water [e.g. by air stripping, activated carbon, UV light, advanced oxidation].

RMM proposed by WHO guidelines for drinking water quality.

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