Nordic Ecolabelling of Dishwasher detergents for professional use

Transcription

1 rdic Ecoabeing of Dishwasher detergents for professiona use Version June March 2020

2 Content What is a rdic Swan Ecoabeed dishwasher detergent? 3 Why choose the rdic Swan Ecoabe? 3 What can carry the rdic Swan Ecoabe? 4 What are the requirements for the rdic Swan Ecoabe? 5 1 Environmenta requirements Genera requirements (appies to a products and a components of muti-component systems) Tota content of chemicas Dosage and packaging Mandatory information and decaration of ingredients Performance and user test Customer visits and visit reports 14 2 Quaity and reguatory requirements 15 3 Take back system 16 Reguations for the rdic Ecoabeing of products 16 Saes in other rdic countries 16 Foow-up inspections 17 How ong is a icence vaid? 17 New criteria 18 Appendix 1 - Removed appendix Appendix 2 Decaration from the manufacturer of dishwasher detergent for professiona use Appendix 3 Decaration from the ingredient manufacturer Appendix 4 Test methods and equations Appendix 5 User test Appendix 6 Information on cassifications (R3) 080 Dishwasher detergents for professiona use, version 2.8, 7 February 2018 This document is a transation of an origina in Swedish. In case of dispute, the origina document shoud be taken as authoritative. Addresses In 1989, the rdic Counci of Ministers decided to introduce a vountary officia ecoabe, the rdic Swan Ecoabe. These organisations/companies operate the rdic Ecoabeing system on behaf of their own country s government. For more information, see the websites. Denmark Ecoabeing Denmark Danish Standards Foundation Göteborg Pads 1 DK-2150 rdhavn Phone E-mai: info@ecoabe.dk Sweden Ecoabeing Sweden Box SE Stockhom Phone E-mai: info@svanen.se rway Ecoabeing rway Henrik Ibsens gate 20 NO-0255 Oso Phone E-mai: info@svanemerket.no Finand Ecoabeing Finand Uhro Kekkosen katu 4-6 E FI Hesinki Phone E-mai: joutsen@ecoabe.fi Iceand Ecoabeing Iceand Umhverfisstofnun Suðurandsbraut 24 IS-108 Reykjavik Phone E-mai: ust@ust.is This document may ony be copied in its entirety and without any kind of ateration. It may be quoted from provided that rdic Ecoabeing is stated as the source.

3 What is a rdic Swan Ecoabeed dishwasher detergent? A rdic Swan Ecoabeed dishwasher detergent for professiona use, or muti-component system, is one of the east environmentay harmfu options avaiabe in its product group. The dishwasher detergent fufis stringent requirements on the heath and environmenta characteristics of its ingre dients as we as performance and efficiency. rdic Swan Ecoabeed dishwasher detergents for professiona use: Contain imited amounts of environmentay hazardous and harmfu substances. Contain readiy biodegradabe substances. Perform equay or better than equivaent products designed for the same function. Have an optima dosage, which is checked during customer visits Dirty dishwater is treated and reeased into nature. It is therefore vita that a constituent substances are readiy biodegradabe. The dishwasher detergent must not contain bioaccumuating or toxic substances that can upset the ecosystem. Many fragrances are aergenic and ecotoxic. Some preservatives bioaccumuate whie others are more environmentay suitabe. Accordingy, rdic Ecoabeing prohibits the use of fragrances and imits the use of preservatives. An important rdic Ecoabeing requirement is that dishwasher detergents for professiona use sha perform on a par or better than estabished products. In comparative testing, the resuts at the recommended dosage must be satisfactory. This is aso checked through reguar inspection visits. Why choose the rdic Swan Ecoabe? The producer may use the Swan trademark for marketing purposes. The rdic Swan Ecoabe is a very we-known and we-reputed trademark in the rdic region. The rdic Swan Ecoabe is a cost-effective and simpe way of communicating environmenta work and commitment to customers and suppiers. Reducing environmenta impact often creates scope for owering costs, such as by cutting the consumption of energy and reducing amounts of packaging and waste. Environmenta issues are compex. It can take a ong time and extensive resources to gain an understanding of a specific area. The rdic Swan Ecoabe can be seen as an aid in this work. The rdic Swan Ecoabe not ony covers environmenta issues but aso quaity requirements, since the environment and quaity often go hand in hand. This means that a Swan icence can aso be seen as a mark of quaity. rdic Ecoabeing of Dishwasher detergents for professiona use (18)

4 What can carry the rdic Swan Ecoabe? These criteria appy to singe and muti-component dishwasher detergents, rinse aids and presoaks for professiona use within institutions and catering centres. The criteria aso covers products that are used in washer-disinfectors destined for instrument maintenance in heath care. Products that are designed for a wash cyce of ess than 20 minutes are considered professiona products, ie aso incuding products for hybride/semi-professiona machines. The maxima ength of the wash cyce within heath care is 30 minutes. The maxima time does not concern presoaks. Dishwasher detergents for specia machines used in food production, dairies, etc., are not incuded. The criteria aso incude routines for customer visits. How to appy Each requirement is marked with the etter R (requirement) and a number. A requirements must be fufied for the award of a icence. Icons in the text The text describes how the appicant sha demonstrate fufiment of each requirement. There are aso icons in the text to make this cearer. These icons are: ( Encose Requirement checked on site Appication The appication sha be sent to rdic Ecoabeing in the country in which the dishwasher detergent, rinse aid or presoak is sod/the appicant carries on activities. See page 2 for addresses. The documents required for appication are an appication form and documentation demonstrating fufiment of the requirements (specified under each requirement). Further information and assistance may be avaiabe. Visit the Web site of the nationa ecoabeing body for more information. On-site inspection During the appication process, rdic Ecoabeing performs an on-site inspection to ensure adherence to the requirements. For this inspection, data used for cacuations, origina copies of submitted certificates, test records, purchase statistics, and simiar documents that support the appication must be avaiabe for examination. Costs An appication fee is charged to companies appying for a icence. There is an additiona annua fee based on the turnover of the rdic Swan Ecoabeed product. Enquiries Pease contact rdic Ecoabeing if you have any queries or require further information. See page 2 for addresses. rdic Ecoabeing of Dishwasher detergents for professiona use (18)

5 What are the requirements for the rdic Swan Ecoabe? To be awarded a rdic Swan Ecoabe icence, a requirements must be fufied. Regarding muti-component systems, cacuations sha be based on the entire system. The requirements in Section 1.1 mean that each individua component must aso fufi the requirement. A muti-component system must at a minimum comprise the components required to pass the performance tests. 1 Environmenta requirements The environmenta criteria are divided into two sections: Section 1.1 contains genera requirements that appy to a products and a components in a muticomponent system. Section 1.2 specifies requirements that appy to a singe component detergent or an entire muti-component system. The requirements in Section 1 appy to a ingoing substances uness specified otherwise. The requirements in the criteria document and accompanying appendices appy to a ingoing substances in the rdic Swan Ecoabeed product. Impurities are not regarded as ingoing substances and are exempt from the requirements. Ingoing substances and impurities are defined beow, uness stated otherwise in the requirements Ingoing substances: a substances in the rdic Swan Ecoabeed product, incuding additives (e.g. preservatives and stabiisers) in the raw materias. Substances known to be reeased from ingoing substances (e.g. formadehyde, aryamine, in situ-generated preservatives) are aso regarded as ingoing substances. Impurities: residuas, poutants, contaminants etc. from production, inc. production of raw materias that remain in the raw materia/ingredient and/or in the in the rdic Swan Ecoabeed product in concentrations ess than 100 ppm (0,0100 w-%, 100 mg/kg) in the rdic Swan Ecoabeed product. Impurities in the raw materias exceeding concentrations of ppm ( 0,1000 w-%, mg/kg) are aways regarded as ingoing substances, regardess of the concentration in the rdic Swan Ecoabeed product. Exampes of impurities are residues of the foowing: residues or reagents inc. residues of monomers, cataysts, by-products, scavengers, and detergents for production equipment and carry-over from other or previous production ines. The requirements in Section 1.1 and 1.2 are based on the highest recommended dosage in grams of product per itre water. rdic Ecoabeing of Dishwasher detergents for professiona use (18)

6 1.1 Genera requirements (appies to a products incuding a components of muti-component systems) Are the requirements met? R1 Description of the product The appicant must provide a detaied description of the dishwasher detergent, rinse aid or presoak for which the rdic Swan Ecoabe is sought. The description sha contain: Descriptions of the products forming part of a muti-component system. Documents supporting that the product is a professiona product, with reference to What can carry the rdic Swan Ecoabe? above. ( Specification compying with the above. R2 Recipe The Compete recipe for the product/products of the dishwasher detergent, rinse aid or presoak sha be submitted as we as the highest recommended dosage. If the appication is for a muti-component system, detais must be provided of a the components. The recipe sha ceary state a constituent substances with name and possibe CAS number, as we as their function and their proportion as a percentage. In cases where an ingredient comprises severa substances, what the particuar ingredient contains sha be decared. A of the foowing parameters must be evident from the submitted information: Producer Trade name Function of each ingredient Chemica name CAS no. DID no. (for substances that can be paced on the ist) Quantity of each ingredient and constituent substances (incuding and excuding water) Cassification according to Counci Directive 67/548/EEC and Counci Directive 1999/45/EC with amendments. The DID number is the number assigned to the ingredient on the DID ist, which is used for the evauation of chemica requirements. The DID ist is avaiabe from rdic Ecoabeing. See page 2 for addresses. DID ist: Detergent Ingredient Database ist. See Appendix 4 for further information. ( Compete recipe for the product/products as specified above. ( Materia safety data sheet/product data sheet compying with appicabe egisation in the country of appication such as Annex II of REACH (Counci Reguation 1907/2006/EEC) and ater additions and changes thereto for each ingredient. R3 Cassification of the product Products must not be cassified as specified in Tabe 1 according to CLP Reguation 1272/2008 with amendments. rdic Ecoabeing of Dishwasher detergents for professiona use (18)

7 Tabe 1 Product cassification CLP Reguation 1272/2008 Cassification Hazardous to the aquatic environmentt Carcinogenicity* Germ ce mutagenicity* Reproductive toxicity* Hazard Cass and Category Code Aquatic Acute 1 Aquatic Chronic 1 Aquatic Chronic 2 Aquatic Chronic 3 Aquatic Chronic 4 Carc. 1A or 1B Carc. 2 Muta. 1A or 1B Muta. 2 Repr. 1A or 1B Repr. 2 - Acute toxicity** Acute Tox 1 or 2 Acute Tox 1 or 2 Acute Tox 1 or 2 Acute Tox 3 Acute Tox 3 Acute Tox 3 Acute Tox 4 Acute Tox 4 Acute Tox 4 Specific target organ toxicity, singe or repeated exposure Skin corrosion/ irritation*** Aspiration hazard Respiratory or skin STOT SE 1 STOT SE 2 STOT RE 1 STOT RE 2 Skin Corr. 1A, 1B or 1C Asp. Tox. 1 Resp. Sens. 1, 1A or 1B Skin Sens. 1, 1A or 1B Hazard statement H400 H410 H411 H412 H413 H350 H351 H340 H341 H360 H361 H362 H300 H310 H330 H301 H311 H331 H302 H312 H332 H370 H371 H372 H373 H314 H304 H334 H317 * The cassifications concern a cassification variants. For exampe, H350 aso covers cassification H350i. ** Cassifications Acute toxicity category 4 H662, H312 and/or H302 are permitted if the packaging is so designed that the user does not come into contact with the product ***Exemption for automaticay dosed product and manuay dosed presoaks where the in-use-soution is not cassified as corrosive at the highest recommended dosage. Corrosive manuay dosed presoaks have to be sod with a pump for dosing or be connected to via product hose to a water source mixing the product to an in-use-soution. The pump needs to be designed to provide correct dosage at the same time as it is minimizing the risk of exposure. Products in containers smaer than 1 itre do not need to be sod together with a pump if the packaging has a chidproof cosure in accordance with ISO 9327:2004 Further information on risk phrases can be found in Appendix 6. Pease note that the manufacturer is responsibe for the correct cassification. ( Materia safety data sheet for the product compying with appicabe egisation in the country of appication such as Annex II of REACH (Counci Reguation 1907/2006/EEC) and ater additions and changes thereto. rdic Ecoabeing of Dishwasher detergents for professiona use (18)

8 R4 Cassification of constituent substances Substances in the product or in the iraw materias must not be cassified in accordance with tabe 2 beow according to CLP Reguation 1272/2008 with amendments. Tabe 2 Cassification of constituent substances CLP Reguation 1272/2008 Cassification Carcinogenicity* Germ ce mutagenicity* Reproductive toxicity* Respiratory or skin Hazard Cass and Category Code Carc. 1A or 1B Carc. 2 Muta. 1A or 1B Muta. 2 Repr. 1A or 1B Repr. 2 - Resp. Sens. 1, 1A or 1B Skin Sens. 1, 1A or 1B Hazard statement H350 H351 H340 H341 H360 H361 H362 H334 H317 * The cassifications concern a cassification variants. For exampe, H350 aso covers cassification H350i. ** Enzymes and preservatives are exempted from this See separate requirements R6 and R8 on enzymes and preservatives. ( Materia safety data sheet compying with appicabe egisation in the country of appication such as Annex II of REACH (Counci Reguation 1907/2006/EEC) for each ingredient. ( Appendix 2 and 3 duy competed and signed, or equivaent signed decarations. R5 Surfactants A surfactants (irrespective of function) must dispay ready biodegradabiity under aerobic conditions in accordance with OECD Guideines for the Testing of Chemicas, test no. 301 A F, or other equivaent scientificay proven test method. This is aso a ega requirement for this category of products. A surfactants must dispay biodegradabiity under anaerobic conditions according to ISO 11734, ECETOC no. 28 or equivaent test method. Documentation sha primariy refer to the DID ist of 2007 or ater. For surfactants not covered by the DID ist, other documentation such as test reports and iterature references may be submitted. The DID ist (Detergents Ingredients Database) is avaiabe on the rdic Ecoabeing webpages (addresses page 2). The ist can aso be found on: ( The documentation of the surfactants sha primariy refer to the DID ist dated January 2007 or ater. For surfactants not found on the DID ist, other documentation such as test reports and iterature references may be submitted (see Appendix 4). rdic Ecoabeing of Dishwasher detergents for professiona use (18)

9 R6 Enzymes Enzymes must be in iquid form or dust-free granuate. Enzymes must be free from micro-organism remnants from manufacture. Products in spray bottes or designed for use in spray bottes or equivaent must not contain enzymes. The producer of the dishwasher detergent, rinse aid or presoak must take precautionary measures to ensure that users are not exposed to enzymes. Specia protective equipment sha protect against high eves of exposure. ( Specification from the enzyme producer or detais on the MSDS/product data sheet in accordance with the requirement. ( Description of measures and methods to protect users. R7 Prohibited substances The foowing constituent substances are prohibited from use in the product and ingredients: Fragrances Reactive chorine compounds Borates and perborates APEO (Aky pheno ethoxyates) APD (Akypheno derivatives) NTA (MGDA and GLDA compexing agents may however contain NTA contaminants in concentrations < 1.0%, as ong as the concentration in the fina product is < 0.10%) EDTA and associated sats Substances with potentia for endocrine disruption of Category 1 or 2 in accordance with officia EU ists. The EU report on endocrine disrupters can be read in fu at fina_report_2007.pdf Nanomaterias/partices (size <100 nm) based on meta, carbon and/or fuorine compounds Substances that have been evauated in the EU to be PBT or vpvb (see LAS (Linear akybenzene suphonates) DADMAC (Diay dimethy ammonium choride) ( Compete recipe for the product/products, as in requirement 2. ( Appendix 2 and 3 duy competed and signed, or equivaent signed decaration. R8 Preservatives The product may contain preservatives provide that the preservatives are not bioaccumuating. A preservative is not considered bioaccumuating if BCF < 500 or ogk ow < 4.0. If both BCF and ogk ow vaues are avaiabe, the highest measured BCF vaue sha be used. The concentration of every singe substance cassified as sensitizing, sha be < 0,10 %. ( Documentation of BCF or ogk ow. ( Compete recipe for the product/products- see K2. R9 Coouring agents Coouring agents must not be considered bioaccumuating. A coouring agent is not considered bioaccumuating if BCF < 500 or ogk ow < 4.0. If both BCF and ogk ow vaues are avaiabe, the highest measured BCF vaue sha be used. Coouring agents approved for use in foodstuffs can be approved. ( Documentation of BCF or ogk ow or specification of E-number for the coouring agent. rdic Ecoabeing of Dishwasher detergents for professiona use (18)

10 1.2 Tota content of chemicas The foowing section appies to a singe component system of dishwasher detergent, rinse aid and presoak for professiona use or the tota quantity in the components of a muti-component system. A components of a muti-component system for which the rdic Swan Ecoabe is sought must be incuded in the cacuations. The cacuations sha be based on the highest recommended dosage if the instructions specify different intervas. The imits in the criteria are set in (m)g / itre water, referring to (m)g / itre inuse-soution and (m)g / itre water in the dishwasher. A imit vaues excude water. Are the requirements met? R10 Environmentay hazardous substances Substances that are cassified as environmentay hazardous are permitted in imited quantities in singe component dishwasher detergents and in muticomponent dishwasher detergent systems. The incusion of substances that are cassified as Hazardous to the aquatic environment Category Chronic 1 H410, Category Chronic 2 H411 or Category Chronic 3 H412 is imited as specified beow. 100 *A H * A H411 + A H412 0,40mg/ itre water At the highest recommended dose: A H410 is the quantity of substances assigned R50/53 or H410 cassification in miigrams per itre water. A H411 is the quantity of substances assigned R51/53 or H411 cassification in miigrams per itre water. A H412 is the quantity of substances assigned R52/53 or H412 cassification in miigrams per itre water. Proteas/subtiisin cassified as Aquatic Chronic 2 (H411) is exempted from the requirement, see further handing of enzymes i requirement O6. te that the product aso must fufi the requirement O3 regarding cassification of the product. Surfactants cassified with H412 are exempted from the requirement, provided that they are readiy degradabe* and anaerobicay degradabe**. * In accordance to the DID-ist or test method. 301 A-F or. 310 in OECD guideines for testing of chemicas or other equivaent test methods. ** In accordance to the DID-ist or ISO 11734, ECETOC. 28 (June 1988) or other equivaent test methods, where a minimum of 60% degradabiity under anaerobic conditions is achieved. If no detais of a substance s environmenta properties are avaiabe it is considered environmentay hazardous with cassification H410. ( Decaration of surfactants that are exempted from the requirement (quantity, cassification, degradabiity). ( Summary of the content of substances and preparations cassified as H410, H411 or H412 in the products in miigrams per itre water. ( Cacuations demonstrating the fufiment of the requirement. ( Materia safety data sheet for each ingredient in accordance with current reguations in the country of appication, such as Annex II of REACH (Counci Reguation 1907/2006/EEC) and ater additions and changes thereto with an account of the substance s environmenta hazard (acute aquatic toxicity, degradabiity and/or bioaccumuating properties). rdic Ecoabeing of Dishwasher detergents for professiona use (18)

11 R11 Critica Diution Voume (CDV) The critica diution voume of a singe or muti-component system must not exceed the imit vaues (at the highest recommended dose) in tabe 3. Acute vaues (CDV acute ) or for chronic (CDV chronic ) vaues may be used. Tabe 3 CDV at the highest recommended dosage Parameter Critica Diution Voume Symbo (unit) Dishwasher detergents and presoaks Rinse aids CDV acute (itre/itre water) CDV chronic (itre/itre water) Documentation sha primariy refer to the DID ist of 2007 or ater. For substances not covered by this ist, other documentation such as test reports and iterature references may be submitted. The DID ist can be found on the rdic Ecoabeing webpages (addresses page 2). The ist can aso be found on: ecoabe/ecoabeed_products/categories/did_ist_en.htm A worksheet for this cacuation is avaiabe from rdic Ecoabeing and can be downoaded from the Swedish and Danish Web sites: aerke=svanen&produktgruppe=80 The cacuation formua for CDV can be found in Appendix 4. The parameter and cacuation formua are found in Section B of the guideines to the DID ist. ( Cacuation of CDV for the singe or muti-component system demonstrating compiance with the requirement. Specify whether the vaues are for CDVacute or CDVchronic. Documentation of each substance sha be refered to the DIDist of 2007 or ater. For substances that are not present on the ist part B of the DID-ist sha be used. R12 Aerobic n-biodegradabe Organics (anbo) and Anaerobic n-biodegradabe Organics (annbo) The tota quantity of organic substances that are aerobic non-biodegradabe or anaerobic non-biodegradabe in the singe or muti-component system for professiona use (at the highest recommended dosage) must not exceed the imit vaues specified in the foowing tabe. te that specia requirements appy for surfactants (see R5). Tabe 4 Limit vaues for aerobic and anaerobic biodegradabiity at the highest recommended dosage Parameter Aerobic non- biodegradabe organics Anaerobic non- biodegradabe organics Symbo (unit) anbo (g/ water) annbo (g/ water) Dishwasher detergents and presoaks * 0.04* Rinse aids *Iminodisuccinate (IDS) and cumene suphonate are exempted from the requirements on anaerobic biodegradabiity. ( Cacuation of anbo and annbo. The parameters and formuas required to document this requirement can be found in Appendix 4. A worksheet is avaiabe from rdic Ecoabeing. rdic Ecoabeing of Dishwasher detergents for professiona use (18)

12 R13 Phosphorous The tota quantity of phosphates and other phosphorous compounds must not exceed the imit vaues specified in tabe 5, cacuated in grams of phosphorous per itre water. The highest recommended dosage sha be used for the phosphorous cacuations. Tabe 5 Limit vaues for eementary phosphorous Parameter Quantity of phosphorous Symbo (unit) Dishwasher detergents and presoaks Rinse aids P (g /itre water) ( Cacuation of the tota quantity of eementary phosphorous in g/ dishwater. R14 Phosphonates/phosphonic acids The content of phosphonates/phosphonic acids must not exceed the imits specified in Tabe 6, cacuated in grams per itre of dishwater. Dishwater refers to the in-use soution in the dishwasher. The highest recommended dosage sha be used for the cacuations. Tabe 6 Limit vaues for the content of phosphonates/phosphonic acids Parameter Phosphonates/ phosphonic acids Symbo (unit) Phosphonates/ phosphonic acids (g/itre water) Dishwasher detergents and presoaks Rinse aids ( Cacuation of the tota quantity of phosphonates/phosphonic acids in g/ water. 1.3 Dosage and packaging Are the requirements met? R15 Dosage The product must be easiy dispensed using an automatic dosage system. If the product is dispensed manuay, cear dosage instructions sha be provided. ( Description of how dosage is normay performed. A dosing instruction for manuay dosed products is required. R16 Pastic packaging and marking of packaging PVC and other haogenated pastics must not be used for packaging and abes. Pastic materias sha be marked in accordance with DIN 6120 part 2 or equivaent. Sma parts (< 5g) are exempted from requirement about marking of packaging. ( Product sheet or description demonstrating what types of pastic the packaging and abe contain. ( Documentation of primary packaging demonstrating that marking compies with DIN 6120 or equivaent marking reguations. rdic Ecoabeing of Dishwasher detergents for professiona use (18)

13 1.4 Mandatory information and decaration of ingredients Are the requirements met? R17 Decaration of ingredients The decaration of ingredients sha compy with EU detergent reguation 648/2004/EC. ( Materia safety data sheet, technica product data sheet or copy of the abe dispaying the decaration of ingredients. R18 Mandatory information Instructions for use stating the recommended dosage (g/ water) for appropriate water hardness vaues must be specified on the packaging or a product data sheet. ( Technica product data sheet or copy of the product abe. R19 User instructions and environmenta advice User instructions with the foowing or equivaent text must found on the product data sheet or product abe: Attempt to wash fu machines whenever possibe Avoid under or over dosing the detergent Wash at the owest temperature possibe resuting in hygienic dishes Information on disposa of empty packaging A printabe version of user instructions sha be avaiabe (for exampe on the web). Pease contact the rdic Ecoabeing body in the appropriate country for the texts appicabe in the oca anguage ( Copy of the product abe or product data sheet demonstrating compiance with the requirement. ( Copy of the user instruction or ink to the webpage where the information can be downoaded demonstrating compiance with the requirement. 1.5 Performance and user test The performance of the singe or muti-component system must be satisfactory at the recommended dosage with soft water. Are the requirements met? R20 Performance and user test The performance and efficiency of the product must be satisfactory. The product must satisfy the requirements for the user test in accordance with Appendix 5. The resuts from tests from at east 8 test ocations sha be submitted aong with a report summarising these resuts and specifying the number and position of respondents. Dosing must agree with the producer s recommendations. The test period must ast for at east four weeks. At east 80% of test ocations must assess the product as offering satisfactory or exceent performance on a accounts (see Appendix 5). Respondents must aso be satisfied or very satisfied with the customer visit agreement. rdic Ecoabeing of Dishwasher detergents for professiona use (18)

14 If products that are destined for use in instrumenta maintenance within heath care (as defined in the product group definition) are tested according to the standard ISO no user tests are required. In case a test report from a certified aboratory (see appendix 4, point 1) showing that the tests have been carried out according to the standard with satisfying resuts sha be incuded as documentation. ( A compete, signed and submitted test reports. Use Appendix 5 or equivaent. ( A report summarising the test resuts and specifying the number and position of respondents. 1.6 Customer visits and visit reports Are the requirements met? R21 Customer visits and visit reports Customer visits sha be made during the icence period in accordance with the suppier s procedures and agreement with each customer. The manufacturer/ suppier must have a standard procedure for customer visits. In exceptiona cases, a customer visit may be waived for occasiona customers if the distance and method of deivery makes the visit impractica and difficut. The customer visit may be performed by a third party, such as a test institute or consutancy firm. The visit report sha be the suppier s standard visit report and contain the foowing items: Check that users have access to care instructions for the dishwasher. Measurement of water hardness or certificate from the water suppier (does not have to be measured every time, but water hardness needs to be documented at a customers). Dosage recommendation at the particuar water hardness. Current dosage. Offer to provide an environmenta advice poster* free of charge. * At east the foowing environmenta advice must be incuded: Attempt to wash fu machines whenever Wash at the owest temperature possibe, resuting in hygienic dishes Pease contact the rdic Ecoabeing body in the appropriate country for the texts appicabe in the oca anguage. rdic Ecoabeing sha on request, in connection to a random inspection, have access to signed and competed visit reports. A visit reports sha be saved during the whoe time that the icense is vaid. ( Copies of dated, signed and competed visit reports, containing the items isted above, from the at east eight customer visits that have been made to fufi the performance requirements under Section 1.5. ( Written report specifying the genera procedures for customer visits and information on who conducts the visits, how often visits are made and which customers are visited. If some customers are not visited a description of them and the reasoning for not visiting them is required. ( Routine for storing visit reports throughout the vaidity of the icense. rdic Ecoabeing of Dishwasher detergents for professiona use (18)

15 2 Quaity and reguatory requirements Are the requirements met? To ensure that rdic Ecoabeing requirements are fufied, the foowing procedures must be impemented. If the company s environmenta management system is certified to ISO , EMAS or equivaent, where the foowing procedures are appied, it is sufficient if the accredited auditor reports that the requirements are impemented. R22 Laws and reguations The icensee must guarantee adherence to safety reguations, working environment egisation, environmenta egisation and conditions/concessions specific to the operations at a sites where the rdic Swan Ecoabeed dishwasher detergent is manufactured. ( Signed appication form. R23 Licence administrators The company sha appoint a contact person responsibe for ensuring the fufiment of rdic Ecoabeing requirements. ( A chart of the company s organizationa structure detaiing the responsibe contacts. R24 Documentation The icensee must be abe to present a copy of the appication and factua and cacuation data supporting the documents submitted on appication (incuding test reports, documents from suppiers and suchike). Checked on site. R25 Quaity of the dishwasher detergent The icensee must guarantee that the production quaity of the rdic Swan Ecoabeed dishwasher detergent (singe or muti-component system), rinse aid or presoak is maintained throughout the vaidity period of the icence. ( Procedures for coating and, where necessary, deaing with caims and compaints regarding the quaity of the rdic Swan Ecoabeed rinse aid, presoak or dishwasher detergent for professiona use. R26 Changes and nonconformities Written notice must be given to rdic Ecoabeing of panned changes and unforeseen nonconformities that have a bearing on rdic Ecoabeing requirements. ( Procedures detaiing how changes and nonconformities are handed. R27 Traceabiity The icensee must have a traceabiity system for the production of the rdic Swan Ecoabeed product. ( Description of/procedures for the fufiment of the requirement. rdic Ecoabeing of Dishwasher detergents for professiona use (18)

16 3 Take back system R28 Take-back system The rdic Ecoabeing s Criteria Group decided on the 9 October 2017 to remove this requirement. R29 Marketing The requirement is removed as decided by the Board of Directors 17 vember Reguations for the rdic Ecoabeing of products When the rdic Swan Ecoabe is used on products the icence number sha be incuded. More information on graphica guideines, reguations and fees can be found at or at Saes in other rdic countries Registering a icence in another rdic country aows the rdic Swan Ecoabe to be used on a arger market. The foowing must be submitted to rdic Ecoabeing: Appication form for registration or origina rdic Swan Ecoabe appication*. Copy of icence. Copy of the product abe and materia safety data sheet. Documentation demonstrating the fufiment of nationa reguations concerning the phosphorus concentration in the product takes precedence in the country of registration. Product turnover in the country of registration. Any marketing materia for the country of registration. Description of procedures for customer visits in the country of registration. The suppier/distributor in the country of registration if other than the icensee. * If the appicant specifies in the origina appication that the product shoud be registered in a further rdic country, this is sufficient. rdic Ecoabeing then coates and forwards the documentation to the country or countries in question. Registration is free of charge but an annua fee sha be paid in accordance with the nationa reguations. rdic Ecoabeing of Dishwasher detergents for professiona use (18)

17 Foow-up inspections rdic Ecoabeing may decide to check whether the rinse aid, presoak or dishwasher detergent for professiona use fufis rdic Ecoabeing requirements during the icence period. This may invove a site visit, random samping or simiar test. The icence may be revoked if it is evident that the rinse aid, presoak or dishwasher detergent for professiona use does not meet the requirements. Random sampes may aso be taken from trade sources and anaysed by an independent aboratory. If the requirements are not met, rdic Ecoabeing may charge the anaysis costs to the icensee. How ong is a icence vaid? rdic Ecoabeing adopted version 2 of the criteria for dishwasher detergents for professiona use on 21 June The criteria are vaid unti 30 June The Secretariat Managers Meeting decided on 16 February 2011 to change R13 Phosphorus and to make an adjustment in the chapter Saes in other rdic countries. The new version is caed 2.1. The Secretariat Managers Meeting decided on 15 December 2011 to adjust the product group definition in order to carify that aso products destined for use in washer-disinfectors in instrument maintenance within heath-care are covered by this criteria. Annexes 2 and 3 were adjusted and a coupe of other minor corrections were made. The new version is caed 2.2. On 12 December 2012 the rdic Ecoabeing Board adopted a change in R10. The new version is caed 2.3. The Secretariat Managers Meeting decided on 15 May 2013 to proong the vaidity of the criteria document with 21 months. The new version is caed 2.4 and it is vaid unti 31 March On 22 October 2014 the Board of Directors adopted a change in R10 Environmentay hazardous substances, where enzyme/subtiisin cassified H411 is exempted from the requirement. The new version is caed 2.5. The rdic Ecoabeing s Criteria Group decided on 17 March 2015 to proong the vaidity of the criteria document with two years. 17 vember 2014 the Board of Directors decided to remove requirement R29 Marketing. The new version is caed 2.6 and it is vaid unti 31 March rdic Ecoabeing s Criteria Group decided on 7 February 2017 to proong the vaidity of the criteria with 24 months to the 31 March The new version is caed 2.7. The rdic Ecoabeing s Criteria Group decided on the 9 October 2017 to remove requirement K28 on take back system. The rdic Ecoabeing s Criteria Group decided on 7 February 2018 to adjust the requirements K3, K4 and K10: references to expired egisation rdic Ecoabeing of Dishwasher detergents for professiona use (18)

18 have been deeted. The definition of ingoing substances was aso adjusted. The new version is caed 2.8. An ecoabe icence is vaid providing the criteria are fufied and unti the criteria expire. The vaidity period of the criteria may be extended or adjusted, in which case the icence is automaticay extended and the icensee informed. Revised criteria sha be pubished at east one year prior to the expiry of the present criteria. The icensee is then offered the opportunity to renew their icence. New criteria The criteria for phosphorous wi be reviewed and the possibiity to forbid phosphate or phosphonates wi be evauated. The possibiity to impose energy requirements wi be investigated. The possibiity to omit the exemption for IDS regarding anaerobic biodegradabiity wi be re-evauated. Evauate if CDV vaues for ony chronic CDV can be used. Evauate the possibiity to give credit (by scoring points or simiar) to ow water fow in the fina rinse to ower the consumption of water. Evauate the possibiity to incude requirements on other factors concerning for exampe probems with the machine. rdic Ecoabeing of Dishwasher detergents for professiona use (18)

19 Appendix 1 Marketing of rdic Swan Ecoabeed dishwasher detergents, rinse aids and presoaks Appendix 1 Marketing is removed as decided by the Board of Directors 17 vember rdic Ecoabeing of Dishwasher detergents for professiona use 2

20 Appendix 2 Decaration from the manufacturer of dishwasher detergent for professiona use Use this appendix when appying for a rdic Swan Ecoabe icence for dishwasher detergent for professiona use. Constituent substances incude a substances in the product, incuding additives in the ingredients (such as preservatives and stabiisers) but do not incude impurities from primary production. Impurity refers to residues from primary production which may be found in the product at concentrations beow 0.01% (100 ppm) provided the impurity has not been activey added for a particuar purpose. Even known substances reeased (such as formadehyde and aryamines) from constituent ingredients are considered as constituent ingredients. Product name: Type of product: Does the product contain fragrances? Does the product contain reactive chorine compounds? Does the product contain borates or perborates? Does the product contain APEO? Does the product contain APD? Does the product contain NTA? If yes, indicate amount in product: If yes, is NTA present as an impurity from MGDA or GLDA? Does the product contain EDTA? Does the product contain substances with potentia for endocrine disruption of Category 1 or 2 in accordance with officia EU ists? (See Does the product contain nanopartices (< 100 nm) based on meta, coa and/or fuoride compounds? Does the product contain substances that are evauated by the EU as PBT or vpvb? (See Does the product contain LAS? Does the product contain DADMAC? Does the product contain coouring agent(s)? If yes, specify the E-number, BCF or ogkow vaue: rdic Ecoabeing of Dishwasher detergents for professiona use 2

21 Are there any substances cassified with the foowing risk phrases in the product? Xn with R42 or Xi med R43 / Resp. sens 1 with H334 or Skin sens 1 with H317 T with R45 and/or R49 (Carc 1 or Carc 2) or Xn med R40(Carc 3) /Carc 1A/1B/2 with H359, H350i and/or H351 T with R46 (Mut 1 or Mut 2) or Xn with R68 (Mut 3) / Mut 1B/2 with H340 and/or H341 T with R60, R61, R64 and/or R33 (Repr 1 or Repr 2) or Xn with R62, R63, R64 and/or R33 (Repr3) / Repr 1A/1B/2 with H360, H361 and/or H362 If yes to any of the above question, pease expain: In case new information gives reason to change the decaration, a new decaration sha be sent to rdic Ecoabeing. Date: Company name: Signature (person responsibe): Name in bock capitas: E-mai/Phone: rdic Ecoabeing of Dishwasher detergents for professiona use 2

22 Appendix 3 Decaration from the ingredient manufacturer Use this appendix when appying for a rdic Swan Ecoabe icence for dishwasher detergent for professiona use. Constituent substances incude a substances in the product, incuding additives in the ingredients (such as preservatives and stabiisers) but do not incude impurities from primary production. Impurity refers to residues from primary production which may be found in the product at concentrations beow 0.01% (100 ppm) provided the impurity has not been activey added for a particuar purpose. Even known substances reeased (such as formadehyde and aryamines) from constituent ingredients are considered as constituent ingredients. Ingredient name: Function of ingredient: Does the ingredient contain fragrances? Does the ingredient contain reactive chorine compounds? Does the ingredient contain borates or perborates? Does the ingredient contain APEO? Does the ingredient contain APD? Does the ingredient NTA? Does the ingredient contain EDTA? Does the ingredient contain substances with potentia for endocrine disruption of Category 1 or 2 in accordance with officia EU ists? (See environment/chemicas/endocrine/pdf/fina_report_2007.pdf) Does the ingredient nanopartices (< 100 nm) based on meta, coa and/or fuoride compounds? Does the ingredient contain substances that are evauated by the EU as PBT or vpvb? (See Does the ingredient contain LAS? Does the ingredient contain DADMAC? Does the ingredient contain coouring agent(s)? If yes, specify the E-number, BCF or ogkow vaue: rdic Ecoabeing of Dishwasher detergents for professiona use 2

23 Are there any substances cassified with the foowing risk phrases in the ingredient? Xn with R42 or Xi med R43 / Resp. sens 1 with H334 or Skin sens 1 with H317* T with R45 and/or R49 (Carc 1 or Carc 2) or Xn med R40(Carc 3) /Carc 1A/1B/2 with H359, H350i and/or H351 T with R46 (Mut 1 or Mut 2) or Xn with R68 (Mut 3) / Mut 1B/2 with H340 and/or H341 T with R60, R61, R64 and/or R33 (Repr 1 or Repr 2) or Xn with R62, R63, R64 and/or R33 (Repr3) / Repr 1A/1B/2 with H360, H361 and/or H362 If yes to any of the above, pease expain: * Enzymes and preservatives are excepted from the requirements for the sensitizing cassifications (see requirement R4). Any addition of enzyme and preservatives sha be reported in this decaration despite the exemption. In case new information gives reason to change the decaration, a new decaration sha be sent to rdic Ecoabeing. Date: Company name: Signature (person responsibe): Name in bock capitas: E-mai/Phone: rdic Ecoabeing of Dishwasher detergents for professiona use 2

24 Appendix 4 Test methods and equations 1 Requirements on the anaysis aboratory The anaysis aboratory used sha fufi the genera requirements of standard EN ISO or have officia GLP status. The appicant s own anaysis aboratory/test procedure may be approved for anaysis and testing if: the anayses and tests are monitored by the authorities, or if the manufacturer has a quaity management system encompassing samping and anaysis and has been certified to ISO 9001 or ISO 9002, or the manufacturer can demonstrate that it is consistent with the initia anaysis/ testing performed as a parae anaysis/test by an accredited aboratory and the manufacturer s own aboratory and that the manufacturer takes sampes in accordance with a predetermined samping programme. 2 Ecotoxicoogica test methods Internationa test methods (OECD Guideines for Testing of Chemicas, ISBN ) or simiar methods must be used. If equivaent methods are used, these must be evauated by an independent body to ensure that the test resuts are equivaent. The test methods to be used are specified beow. 3 Acute aquatic toxicity Use test methods 201, 202 and 203 in the OECD Guideines for the Testing of Chemicas (ISBN ), or equivaent method to test aquatic acute toxicity. 4 Bioaccumuation A substance is considered bioaccumuating if tested for bioaccumuation on fish according to method OECD 305 A E and its bioconcentration factor (BCF) is >500. If no BCF vaue has been determined, a substance is considered bioaccumuating if its ogk ow vaue 4.0 according to method 107, 117 or 123 in the OECD Guideines for the Testing of Chemicas (ISBN ) or equivaent method, uness proven otherwise. If highest measured BCF 500, the substance is not considered bioaccumuating even if ogk ow 4.0. OECDs test method 107 cannot be used for surface-active substances, which are both fat and water soube. Based on current knowedge, for such substances it must be shown to a high degree of certainty that the substance itsef and its decomposition products do not pose a ong-term hazard to aquatic organisms. Computer modes (such as BIOWIN) are permitted but if the resuts of an approximation are cose to the set imit vaues or if rdic Ecoabeing hods contradictory information, more reiabe information is required. rdic Ecoabeing of Dishwasher detergents for professiona use 2

25 5 Aerobic biodegradabiity Test methods 301 (A to F) or 310 in the OECD Guideines for the Testing of Chemicas (ISBN ) shoud be used to test aerobic biodegradabiity. Other scientificay accepted test methods may aso be used. The test resuts of such equivaent methods must be evauated by an independent body. 6 Anaerobic degradabiity Use ISO 11734, ECOTOC no. 28 (June 1988) or equivaent test method to determine anaerobic biodegradabiity. For a substance to be considered to biodegrade anaerobicay, a mineraisation of >60% within 60 days is required (equivaent to >60% ThOD/ThCO 2 or >70% DOC reduction). Substances, other than surfactants, that are not found on the DID ist may be exempted from the requirement on anaerobic biodegradabiity if the substance dispays: Ready aerobic biodegradabiity and ow adsorption (A < 25%), or Ready aerobic biodegradabiity and high desorption (D < 25%), or Ready aerobic biodegradabiity and no potentia to bioaccumuate. Test method 106 in the OECD Guideines or ISO CD Water quaity Adsorption of substances on activated sudge is used to estabish adsorption/ desorption vaues. 7 DID ist The DID ist is common to the European ecoabe and rdic Ecoabeing. The ist has been estabished in coaboration with stakehoders from industry and consumer and environmenta organisations. The ist contains information on the toxicity and biodegradabiity of substances that may be used in chemica/ technica products. The DID ist does not show which substances can be used in ecoabeed products. The DID ist cannot be used to document the toxicity of individua substances for cassification purposes. For this purpose, MSDS, pertinent iterature and information from the ingredient suppier sha be used. The DID ist is avaiabe from the ecoabeing body or via the nationa ecoabe website (see page 2 for addresses). Vaid to these criteria is the DID ist dated January 2007 or ater. 8 CDV cacuation Critica diution voume, CDV acute and CDV chronic, is cacuated as foows: CDV acute = CDV(i) = 1000 dosage(i) x DF(i)/TF acute (i), or CDV chronic = CDV(i) = 1000 dosage(i) x DF(i)/TF chronic (i) rdic Ecoabeing of Dishwasher detergents for professiona use 2

26 Dosage(i) = Dosage of ingredient (i), expressed in g/ DF(i) = Degradation factor of ingredient (i), as specified on DID ist. TF acute (i) = Acute toxicity factor of ingredient (i), as specified on DID ist. TF chronic (i) = Chronic toxicity factor of ingredient (i), as specified on DID ist. DF and TF sha where possibe be taken from the DID ist dated January 2007 or ater. The DID-ist can be found on the rdic Ecoabeing webpages (addresses page 2). The ist can aso be found on: part_b_en.pdf If an ingredient is not found on the DID ist, the factors sha be set as foows: DF (see aso Part B of the DID ist): 0.05 for organic substances that are readiy biodegradabe according to Appendix for organic substances that are readiy biodegradabe according to Appendix 2 but for which the 10-day window is not met (excuding surfactants). 0.5 for organic substances that are inherenty biodegradabe according to Appendix for persistent organic substances. TF (see aso Part B of the DID ist): TF = toxicity/sf, where the toxicity is the owest found acute LC50/EC50/IC50 vaue, and SF is determined according to the foowing. SFacute (see aso Part B of the DID ist): Substances with acute toxicity data for each of three trophic eves Substances with acute toxicity data for two trophic eves Substances with acute toxicity data for ony one trophic eve. SFchronic (see aso Part B of the DID ist): 10 Substance with thee ong-term NOEC from at east three species representing three trophic eves. 50 Substance with two ong-term NOEC from at east two species representing two trophic eves. 100 Substances with one ong-term NOEC (fish or crustaceans). rdic Ecoabeing of Dishwasher detergents for professiona use 2