3. User Manual - Sustainable Cleaning
Contents
1. Decomposition product e phtaloimidohexanoic acid PAC e PNEC 0 025 mg l e Removal 87 e PESR for 3 PAP 2 83 PAC use in ADW Factor 2 5 0 77 Approach use PAC parameters in ESC Tool as that is more sensitive A note is added to the ingredient description that parameters used are for PAC expressed as e phthalimidohexanoic acid 3 Chlorinated isocyanurate Ingredient 253 dissociates in water to giving cyanuric acid and hypochlorite Ing 236 which is exempt from PESR calculation on the basis of the EU Existing Chemicals Risk Assessment Decomposition product cyanuric acid e PNEC 12 1 mg l e Removal 0 not inherently biodegradable e PESR for 30 NaDCC 17 6 cyanuric acid use in ADW default tonnage 0 24 Approach use cyanuric acid parameters in ESC Tool as hypochlorite is exempt from PESR calculation A note is added that parameters used are for cyanuric acid expressed as cyanuric acid 4 9 Multi component mixtures Substances that consist of multiple chemical constituents should be split for checking in the ESC Tool calculation into their single constituents according to CAS Numbers and or ingredient numbers assigned in the Tool However in the event that an ingredient is purchased as a commercial mixture the mixture may be treated and checked in the Tool as a single ingredient provided e an aquatic PNEC for the mixture is known AND either e environmental data for one or more constituents cannot be2. Log Pow Readily biodegradable Inherently biodegradable Poorly biodegradable lt 2 0 87 0 4 0 2 4 0 9 0 5 0 25 s4 0 93 0 7 0 6 Surfactants 0 95 Ecotoxicity The ecotoxicity of a substance is derived from the available acute and chronic ecotoxicity data according to the rules for deriving the PNEC as outlined in the Guidance on Information Requirements and Chemicals Safety Assessment Ch R 10 Characterisation of dose concentration response for environment The lowest i e most toxic ecotox value should be divided by the following Assessment Factors according to whether chronic or acute tox data are available for 1 2 or all 3 trophic groups fish invertebrates and algae Data Available Assessment Factor 1 Acute 1000 2 Acute 1000 3 Acute 1000 1 Chronic 100 2 Chronic 50 3 Chronic 10 34
3. the content can be adjusted to take account of the difference in molecular weight from the original substance The Stage 2 notification should submit two forms one covering the substance and one the decomposition product When a Stage 2 notification is ratified and the ingredient added to the ESC Tool the name of the original substance will be used but if the decomposition product represents the more sensitive case the ESC parameters used will be those for the decomposition product and that shall be explained in a note alongside the ingredient description Examples 1 Peracetic acid Ingredient 254 decomposes during use and in sewers and drains following disposal to acetic acid acetate at sewage pH water and oxygen e PNEC 0 000224 mg l e Removal rate 99 95 e PESR for 0 5 in consumer solid laundry using default tonnages 0 72 Decomposition product acetic acid acetate Ingredient 160 e PNEC1mg l e Removal 87 e PESR for 0 5 PAA 0 4 acetate in consumer solid laundry using default tonnages 0 12 Approach use a conservative approach by using peracetic acid parameters in ESC Tool as that is the more sensitive case 2 e phtaloimidoperoxyhexanoic acid PAP Ingredient 92 decomposes during use and in sewers and drains following disposal to e phtaloimidohexanoic acid PAC water and oxygen e PNEC 0 00059 mg l e Removal rate 99 8 e PESR for 3 use in ADW Factor 2 5 0 53 16 Version 7 0 1 October 2014
4. S E members during the ESC implementation The substance effects assessment follows the generally accepted rules of the REACh technical guidance on information requirements and chemical safety assessment R10 In those cases where only limited data has been used to derive the effects assessment of stage 1 it may be possible to challenge the existing data by newly becoming available information for example to improve the assessment factors The new information should be validated to ensure a sufficient quality 5 Refinement of environmental exposure A refinement of the substance exposure can also be achieved by representative data on environmental monitoring Where such data is available it can be used to either refine specific removal information e g by sewage treatment monitoring or environmental background data e g by river monitoring Where monitoring data are matter of disclosure adequate information should be available on request in Charter audits 27 Version 7 0 1 October 2014 Conclusion A refinement of the environmental screening risk assessment of ESC stage 1 follows five different options for improvement within the exposure and or the effects assessment of a substance While the implementation of new test data follows the principles of acknowledged technical guidance tiered risk assessment the refinement of tonnage estimations requires a deeper insight into market situations of the products In all cases appropr
5. and by an overall flowchart document highlighting the main step of the ESC process Version 7 0 1 October 2014 2 Overview of the ESC Tool The ESC Tool is an Excel spreadsheet workbook which provides a quick and easy way for companies to check that their products pass the ESC check in respect of each ingredient at the level used in the formulation The spreadsheet contains formulae to calculate projected aquatic environmental safety ratios PESRs in a uniform way so all products are compared to the same benchmark It also contains the environmentally relevant key data required ecotoxicity removal rates from sewage flows tonnage estimates and projection factors for other uses on most of the ingredients used in the product categories currently covered by the Tool For most formulations performing the ESC check should be quick and straightforward This is termed a Stage 1 check and is done using just the first sheet of the Tool workbook by entering the formulation details into the spreadsheet There is an Ingredient search sheet to help you identify and enter ingredients However there are also facilities to enable companies both to enter additional ingredients and or where necessary refine the key data provided for existing ingredients This is termed a Stage 2 check Key data used by a company in a Stage 2 check for any new non proprietary ingredients added or any refinement of data on existing ingredients must be notified to A I S
6. from registration under REACH Some ingredients listed in the tool already have such an exemption applied but if an ingredient not listed meets the criteria set out in Annex A of this Manual you may enter those as exempted ingredients using ingredient numbers 208 inorganic or 209 organic as appropriate When you have entered all the ingredients on the ESC Check Form using a separate line for each view the results of the check in column J To pass the check the result for all ingredients should be Clear i e no result should be coloured Red If no results are red for your product formulation it has passed the ESC check and has qualified as meeting that aspect of the ASP PESR results between 0 5 and 1 are coloured Amber rather than Green only to highlight ingredients use levels that give results closer to 1 Amber results have no significance for passing the check If one or more results are red or some ingredient s are not already in the Tool you will need to conduct a Stage 2 ESC check if you wish to qualify for the ASP 4 7 Trigger sprays When performing an ESC check for a trigger spray product you will notice that a message appears on Row D of the Check Sheet saying that the Tool will always use 10g as the recommended product dosage per task for this category You do not need to enter a dosage figure Whatever figure you input in cell C6 the Tool will always base PESR calculations for trigger sprays on a standard d
7. industries tonnage of 1000 tpa may be assumed e Ifthe substance is an HPV chemical but no tonnage data are published and there are no specific data in SRI CEH report and not SRI a total all industries tonnage of 10 000 tpa may be assumed The ESC calculation default assumes conservatively that all this tonnage goes to drain via sewage treatment If necessary the tonnage can be reduced by discounting the proportion that would not go to 31 Version 7 0 1 October 2014 drain provided this can be justified A simple method of refinement could use assumptions such as the following e Uses in cleaning personal care pharmaceuticals food etc 100 to drain STW e Uses where the ingredient is incorporated into materials e g plastics rubber glass 0 to drain STW o The same may apply for e g textiles paint paper where the ingredient becomes part of the product but it could conservatively be assumed 10 goes to drain STW to account for waste leaching from disposal after use etc Refinement may also be performed by reference to published emission scenarios e g TGD REACH etc When the tonnage estimate has been defined this needs to be converted into a factor to be entered in column J of the Base Data sheet which the tool will then apply to the estimated use in cleaning products This will ensure a conservative estimate of background tonnage from other industries that does not need regular monitoring and updating Choose whichever
8. readily obtained including through the use of QSARs OR e the mixture is proprietary and the owner is unwilling to disclose the composition of the mixture In such cases e the mixture must be notified and ratified as an ingredient through a Stage 2 Check following the provisions of Section 5 of this Manual 17 Version 7 0 1 October 2014 e since removal biodegradability has meaning only for the individual components removal rate for the mixture should be assumed to be zero e since some ingredients may have extensive uses in other industries a default tonnage factor of 10 should be assumed Note that as regards the latter two provisions above if you believe sufficient information is available on the mixture and its components to support either a higher removal rate for the relevant toxicants or lower tonnages this may be proposed and discussed on a case by case basis with A I S E 18 Version 7 0 1 October 2014 5 How to do a Stage 2 ESC check 5 1 Ingredients not already in the Tool If some ingredient s in the formulation are not in the supplied list on sheet 2 of the Tool you may add your own data as follows Before doing this double check that the ingredients are not already included under a different description by using the CAS Search Facility section 4 1 i a Enter data for each additional ingredient using the empty rows towards the end of the Base Data sheet sheet 2 e Enter the ingredient name in C
9. to avoid double counting However because this substance specific tonnage for a product category is often not available the tool assumes as a default that both tonnages go down the drain the projected category tonnage and the A I S E tonnage respectively Hence in such cases the category tonnage will be double counted b No A I S E tonnage available where no substance specific use tonnages for total cleaning products are available the tool assumes as a default that the use tonnage in other A I S E categories will be the same as the projected tonnage for the category Since this projected category tonnage is calculated assuming 100 market share for the product it is rather conservative For current ASP product categories estimating the use in other A I S E categories to be similar will again be generally conservative gt The industry association for body care and detergents known as the Industrieverband K rperpflege und Waschmittel e V IKW A 1 S E is used in this document as shorthand for all cleaning products within the sectors covered by A I S E whether or not produced by an A S E member company Version 7 0 1 October 2014 3 2 2 Other industries tonnage projection The background PEC arising from emissions from use of products of other industries initially uses tonnage estimates derived as far as possible from published literature In some cases it is conservatively assumed that total use in other industries
10. Concentrations PNEC The result is expressed as a Projected Environmental Safety Ratio PEC PNEC PESR To derive environmental concentrations reflecting the potential environmental load of the product formulation in a simple yet conservative i e worse case approach and one that is independent of its actual use volume and market share the tool hypothetically projects environmental concentrations using a standard benchmark market share For the current ASP product categories this benchmark market share has been set at 10096 i e the projected environmental concentration assumes the same formulation is used for all products in the category on the market This concentration is termed the Category PEC To take account of quantities of each ingredient that may be entering the aquatic environment from other uses the Category PEC is added firstly to a PEC reflecting use tonnages in other categories of cleaning products cf 3 2 1 other A I S E tonnage projection and secondly to a PEC reflecting likely down the drain emissions from the products of other industries cf 3 2 2 Other industries tonnage projection These additional projections together represent a background environmental concentration Each of the PECs are calculated from a conservative tonnage estimation The methods used for the tonnage projections are given below Version 7 0 1 October 2014 3 1 Projected Category Tonnage The projected Catego
11. E for ratification and improvement extension of the Tool The Stage 2 check is only passed when the relevant data have been ratified by A S E as valid for use in the ESC Tool Once a company has completed the ESC check for a product the result and relevant underlying data should be archived for future reference and in case required for random verification under the provisions of Charter Update 2010 In all cases the archiving requirement is that sufficient data and the date the check was done should be retained so that in the case of the product being chosen for random verification audit the auditor can repeat the check and obtain the same result The first sheet in the workbook ESC Check Form contains blank rows into which the various ingredients used in the formulation to be checked can be entered The second sheet contains a list of ingredients that are relevant for cleaning products Only the first two columns need to be referred to the others being used for internal calculations only e Those ingredients numbered up to 204 are broadly the same substances as those included in the EU Eco label DID list and German HAD list though some have been grouped together and a few modified e Ingredients 205 to 207 are additional substances for which HERA risk assessments are available e Ingredients 208 and 209 allow the recording of certain exempt low risk ingredients see Annex A DID Detergent Ingredient Database EU Commis
12. Form sheet 1 fill in the pale yellow boxes C1 to C4 Note Box C3 has a pull down menu for you to select which of the product categories the product belongs to The date is These are ingredients classified under DSD as R50 R50 53 or R51 53 or under CLP as Acute cat 1 H400 Chronic cat 1 H410 or Chronic cat 2 H411 Version 7 0 1 October 2014 automatically entered for you in Box C5 In Box C6 enter the recommended dosage per task for the formulation medium hardness normal soiling where applicable in grams NB The maximum doses which allow a product to qualify for an ASP as regards the LCA parameters are e solid laundry detergents 75 g or 115 ml e liquid laundry detergents 75 ml e fabric conditioners 35 ml automatic dishwash detergents e powders unit doses including rinse function 25g e powders unit doses NOT including rinse function 20g e liquids 35ml dilutable all purpose cleaners 12 g L Trigger sprays Pass the ESC check based on a product dosage of 10ml as upper limit for wetting a surface of 1m You do not need to enter a dosage figure Whatever figure you input in cell C6 the Tool will always base PESR calculations for trigger sprays on a standard dosage of 10g task Manual dishwash detergents 5mL 5L of wash water Toilet cleaners 55 ml Professional building care products 10 g L corresponding to a dilution rate of 1 100 It is most important the correct category and dosage are selected because al
13. HERAOK pT ESC Check Form Base Data Details 24 Version 7 0 1 October 2014 Annex C Worked example of how the spreadsheet does the calculation ESC stage 1 Worked example of how the spreadsheet does the calculation Data entered by manufacturer Key data applied from ESC database Dosage of product gms wash PNEC Predicted No Effect Concentration 0 1 mg l 85 Ingredient Number Removal Rate in sewage treatment 95 49 Content Ingredient 49 Tonnage used in A I S E uses 11 400 tpa 8 Factor Total A S E similar non A I S E use volume 2 5 Projected background tonnage including other industries 11 400 2 5 28 500tpa 1 Company Product Name T Product Category drop down list 4 Fotmukation Date Tari COSE al Go AUNG AG a Recommended product dosage gluse ESC Pl pa Tiede PESK PESR PESR Total t ahont wiw in Formutation Status SC Result tae PNEC GEC Category Total AISE All Inds yt Calegor a8 2 18 or C12 15 AYI polygiycoside Pung NY e oraa azsa azes Damo EE aaa AA SSS Product Category OtherUses Looe SFIS ES ROE of Ingredient 49 per wash 85 x 8 6 8 gms wash Po Ingredient usage cap year e Solid laundry detergents are used on average 51 x 6 8 for 51 washes cap yr IKW figures 346 8 gms cap yr SEG iain T e Other uses 28 500 tpa 370 Million EU 77 gms cap yr populations Amount entering sewage treatment per d
14. SC Check Form exactly as they appear If the Spreadsheet is operating correctly it should automatically fill in the results seen in the example If the results are not as displayed in the example please download a fresh copy and re try or contact Sophie Mathieu at A 1 S E sophie mathieu aise eu for help before proceeding further Once the spreadsheet is validated you can begin to use the tool 2 Full compliance with all ESC requirements is needed to comply with the ASP Advanced Sustainability Profile for current ASP product categories In all cases the archiving requirement is that sufficient data should be retained so that in the case of the product being chosen for random verification external audit the auditor could repeat the check even though it is not required to be shared with A 1 S E 4 1 Main ingredients All ingredients intentionally included in the formulation at levels of 0 1 and above must be checked in the ESC tool For ingredients used at lower inclusion levels i e lt 0 1 the following principles apply e Ingredients with an acute aquatic toxicity below 100 mg l L E C50 lt 100 mg l should be checked in the ESC tool when used at levels above 0 01 e Additionally ingredients that have to be labeled with the dead tree dead fish pictogram under DSD or under CLP should always be checked in the ESC tool regardless of their inclusion level For each product that you wish to check e On the ESC Check
15. The Chemical Economics Handbook CEH published by SRI Consulting Inc This is major source of chemical market research data available on subscription Whether or not a substance is covered in a CEH report or other parallel SRI programmes can be checked on the SRI website at http www sriconsulting com cgi bin search pl A substance for which careful searching reveals no information in the CEH reports can be assumed to have a use tonnage below 10 000 tpa e Suppliers may be asked to supply or confirm estimates Companies may also search for data using other market research internet or library sources In some cases official production consumption statistics may be useful though in most cases they will reflect broad groups of products but such data may still be helpful as a very conservative estimate Tonnage data should be estimates relevant for the EU 15 European countries Tonnage data should ideally be European figures e g EU 15 or EU 27 with a population of 370 or 500 million However data may be extrapolated either from comparable regions e g USA or from particular countries as long as care is taken to ensure the estimate remains conservative When new tonnage data has been gathered and if there are several values from different sources a tonnage should be estimated reflecting the balance of data Where there are no firm data the following assumptions may be used e Ifthe substance is not listed as an HPV chemical a total all
16. a _gnaboility ay Version 7 0 1 October 2014 Charter Update 2010 Environmental Safety Check ESC MANUAL FOR USE OF THE SPREADSHEET TOOL for ASP Product Categories Solid and Liquid Laundry Detergents Fabric Conditioners Automatic dishwash Detergents Dilutable All Purpose Cleaners Trigger sprays Manual dishwash Detergents Toilet cleaners Professional building care products Version 7 0 1 October 2014 Version 7 0 1 October 2014 1 Introduction To qualify their products as achieving Advanced Sustainability Profile ASP status for the relevant category Charter Update 2010 member companies must in addition to meeting all the other ASP criteria be able to confirm environmental safety of their product in terms of each ingredient using the formal agreed ESC scheme A product is considered to meet this requirement of ASP status if all ingredients can be shown by using the ESC spreadsheet Tool Stage 1 to give projected environmental concentrations which are below the predicted no effect concentration for aquatic toxicity This concept is well established for performing environmental risk assessment The ESC Tool contains relevant data on most of the ingredients used in the ASP product categories covered solid and liquid laundry detergents fabric conditioners automatic dishwash detergents dilutable all purpose cleaners including floor cleaners trigger sprays glass window bathroom kitchen and hard surface all purpose
17. any should provide you with the ESC number they have obtained from A I S E following notification and ratification of that ingredient and the key parameters to be entered in the Tool to perform the ESC check for that ingredient 5 2 Refinement of key data on ingredients already in the tool If the existing key data is likely to be too conservative and leading to a red result for an ingredient key data already in the tool may be refined This refinement follows the concept of a tiered risk assessment The circumstances in which this may be done are set out in Annex D Before embarking on refinement of existing data check carefully that all ingredients have been correctly entered In particular check that ingredient use levels have been entered in terms of active ingredient e g for preservatives and dyes Refined key data on exposure and or effects assessment should be derived following the procedures set out in Annex E and or Annex F The procedures for adjusting data in the tool when one or more parameter is to be refined are as follows To avoid possible corruption of the tool all data on existing ingredients are protected The existing entries in columns B to J of the Base Data Sheet should therefore be copied into a new entry in a blank row using a new ingredient number The relevant refined data can then be entered to replace previous values as follows e PNEC enter refined value in mg l in the Base data Sheet Column D e Removal
18. ay 346 8 365 77 365 0 94 gms person day 0 21 gms person day Amount of ingredient leaving sewage treatment 0 94 x 1 95 0 21 x 1 95 0 047 gms person day 0 011 gms person day This will be contained in 200 litres of sewage 0 047 x 1000 200 x 10 0 011 x 1000 200 x 10 effluent which is further diluted 10 times into the receiving water Thus 0 0235 mg litre see Col 0 0053 mgllitre Projected Environmental Concentration G above Total Projected Environmental Concentration 0 0235 0 0053 0 0288 mg l Product Other Uses Projected Environmental Safety Ratio 0 0288 PNEC 0 1 0 288 PESR see Column J above PESR 0 288 is lt 1 so ESC Check is clear for this ingredient in this product at this level 25 Version 7 0 1 October 2014 Annex D Higher Tiered Risk assessment in the ESC Scheme Scope This paper describes the refinement options of the product based environmental safety check ESC of the A I S E Charter Update 2010 Background The ESC allows assessing the environmental risk potential of a substance due to its use in washing and cleaning products simplified product based environmental risk assessment Because of the use pattern of these products the ESC focuses on the aquatic compartment only The ESC tool implements stage 1 of this risk assessment The stage 1 assessment reflects an environmental screening risk assessment because for example e it assu
19. cleaners manual dishwash detergents toilet cleaners and professional building care products This has been reviewed and refined where necessary for these product categories by the A I S E ESC Expert Panel but there are provisions for companies both to refine this data where necessary and to add other ingredients not already included in the Tool To pass the check no result should be coloured Red after evaluation in the ESC Tool If no results are red for your product formulation it has passed the ESC check and has qualified as meeting that requirement of ASP status If one or more results are red or some ingredient s are not already in the Tool you will need to conduct a Stage 2 ESC check if you wish to qualify for the ASP This Manual comprises the following chapters and relevant Annexes 2 Overview of the ESC Tool cc ccessssssscsscsssessessessesesscsscssceseeseesessssscsscsseessesseseases Page 3 3 Calculations performed by the ESC Toll sesssssssssscsscsscecsessecessesscesseseessees Page 5 4 How to use the ESC Tool Stage1 cssscsscssssccescesssecseseesscsesseesacsessossessessaesees Page 9 5 How to do a Stage 2 ESC Check ee anuano nanana nnaana nna nna wa nawnaasaasaa sna nsansasanaaa Page 19 o Ingredients not already in the Tool o Refinement of key data on ingredients already in the tool 4 SAVIMOXOS NAIA BALAK Page 22 This Manual is accompanied by the ESC Tool excel calculation sheet itself
20. clude actual use in the Category thus effectively double counting the usage If it is necessary to eliminate this double counting an estimate must be made of the percentage of A I S E tonnage of the specific ingredient that is used in the Category This should be based on firm data from internal or market research sources If the default estimate gives a value which you believe to be likely to be much too conservative you may forward the relevant information to A 1 S E and request A 1 S E to consider whether a refined estimate can be made Note that if A I S E tonnage is reduced the Factor which translates A I S E tonnage into tonnage for all down the drain uses see below must be re considered in case this needs to be increased to maintain a correct estimate of total background tonnage 2 Tonnage used in industries other than cleaning products Annual tonnage used in other industries must first be estimated as a figure relevant for the EU 15 countries If no breakdown of total use into cleaning and other uses is available the total tonnage including cleaning products may be used as a conservative figure Tonnage estimates can be approached on a tiered basis i e rough estimates and extrapolations or older data can be adequate provided they are clearly conservative and or the calculated PESR is sufficiently low e g lt 0 1 as not to be sensitive to several fold variations in the tonnage The following important sources of to
21. d approach of the ESC scheme the possibility of a risk from the decomposition product also needs to be checked For substances where decomposition is slow the standard risk based approach in ESC is adequately based on the parent ingredient alone To take account of the possibility that the products of rapid and near quantitative decomposition could present a more severe risk than the parent the parameters used in the ESC Tool for the ingredient should reflect the more sensitive of the two cases i e those which give the highest most adverse PESR ratio The examples below illustrate the decision process Some reactive ingredients entered in updated versions of the ESC Tool may therefore have parameters for a decomposition product instead of the original substance The ingredient name will still be that of the substance as used but the use of parameters for the decomposition product will be noted alongside the ingredient to avoid confusion e g Chlorinated isocyanurates expressed as cyanuric acid 15 Version 7 0 1 October 2014 Conducting a Stage 2 check for a reactive ingredient which is rapidly decomposed If you need to conduct a Stage 2 check for such a reactive ingredient you should check both the original substance and the decomposition product using appropriate ecotox removal and tonnage parameters for each to establish which is the more sensitive i e gives the highest most adverse PESR When checking the decomposition product
22. er sprays is set at 10g task a task effectively being defined as cleaning 1 m Base Data sheet cell C4 and the recommended product dosage is fixed at the same value as explained above so no adjustment based on dosage takes place This approach will produce an appropriate assessment for trigger sprays of similar concentration and application rates Should novel products be developed in future which are more concentrated and which need and are designed to deliver much lower application rates it would be necessary to make an appropriate adjustment in the PESR calculation If you need to perform ESC checks for such a product you should in the first instance notify sophie mathieu aise eu at A I S E to discuss the requirement 4 8 Reactive substances which are rapidly decomposed A number of reactive ingredients used in cleaning products e g oxidising agents exhibit substantial ecotoxicity often associated with their reactivity but also decompose during use and or upon disposal into drains and sewers such that the source of the toxicity disappears In some cases e g hydrogen peroxide the decomposition products are not ecotoxic In others e g sodium dichloroisocyanurate the dominant decomposition product s may also have significant eco toxicity In a case where immediate decomposition approaches 100 the ESC calculation might correctly show no risk from the original reactive ingredient but in line with the precautionary and risk base
23. heets unless the substance is also classified R53 s For Example see 147 No XX Survey of azo colorants in Denmark Consumption use health and environmental Aspects Section 6 3 4 By Henriette llgaard Lydia Frost Johan Galster and Ole Christian Hansen Danish Technological Institute Environment November 1998 Ministry of Environment and Energy Denmark Danish Environmental Protection Agency http www miljoindflydelse dk udgiv publications 1999 87 7909 548 8 pdf 87 7909 546 1 pdf 12 Version 7 0 1 October 2014 Cell B7 in the dye box returns the ESC Ingredient number to be entered in Column A of the ESC Check Form sheet 3 In case your colourant is not listed go to the dye matrix F I 1 17 on the Ingredient Search Sheet With the environmental classification of the colourant pick the relevant ESC ingredient number Take the removal rate 096 as default in the absence of further information Note that if the formulation you are checking contains two or more colourants that have similar ecotox and removal parameters such that they have the same ingredient number in the first instance add the contents together and enter the total against the ingredient number If this produces a Red result and provided that the colourants concerned are chemically different such that they would not be expected to share the same mode of ecotoxic action you may apply a more precise approach and check the colourants individually The check sho
24. her Tiered Risk assessment in the ESC SCheMe ccseseceecescsectecseeeseeeeeeseaees Page 26 Annex E Procedures for estimating ingredient tonnages for the use in the ESC Spreadsheet Tool renec anai nea e Page 29 Annex F Guidance on inclusion of aquatic toxicity and removal rate data for use in the ESCSpreadsheet T001 ana AARAL ALAN MA Dala hh Page 33 22 Version 7 0 1 October 2014 Annex A Ingredients exempt from the ESC Check A range of non hazardous substances are considered exempt from the ESC check as their properties are such that use in detergents clearly poses no risk to the aquatic environment when disposed of via sewage treatment These include both simple inorganics such as sodium chloride and some organics from natural sources such as starch Some simple acids and bases which may be hazardous in concentrated form e g hydrochloric acid and sodium hydroxide are exempt on the basis that they are routinely diluted and neutralised during sewage treatment Where these substances already appear in the DID list an exemption is applied directly by the ESC Tool e g ingredients 121 134 and 144 Apart from this companies may assign other non hazardous inorganic and organic substances not on the list to ingredient numbers 208 and 209 respectively and thus be exempted from PESR calculation if they meet the following criteria e Ingredient 208 Any soluble salts composed only of the following ions Na K Ca Mg NH or H
25. iate data reviews and documentations should be ensured to maintain the high data quality in the ESC scheme of the A S E Charter Further to that information non proprietary substances should be reported to A I S E to stimulate a continuous improvement of ESC 28 Version 7 0 1 October 2014 Annex E Procedures for estimating ingredient tonnages for the use in the ESC Spreadsheet Tool For ingredients already listed in the ESC Tool tonnage data factors and or default assumptions are included see Manual Section 3 2 as a basis for estimating the background environmental concentrations from both other uses in cleaning products i e A I S E industries related product uses outside the category of the product being evaluated and uses in other industries products background tonnage If a company wishes to include new or refine existing data in the tool referring to use tonnages and or substance use pattern they do so in stage 2 of the ESC process All such changes are subject to notification to A I S E and the data must be ratified by A I S E before the ingredient passes the ESC Check Companies may wish to add new tonnage estimates or factors into the tool in the following circumstances a For core ingredients already listed in the tool i To replace default values in respect of A I S E use ii To refine conservative Factors estimating down the drain tonnage from use in other industries iii To eliminate double count
26. iered simulation studies the values may be adjusted accordingly Removal efficiencies of substances with low or no biodegradability were determined according the procedures outlined by the HAD see Annex F The calculations use standard EU TGD assumptions for dilution rates into sewage influent and of sewage effluent into receiving waters The quantities of ingredient entering sewage works are reduced by a removal rate derived following the approach set out in the HAD scheme as explained in Annex F 3 4 PNEC Derivation The Predicted No Effect Concentration for each ingredient is based on available acute and chronic aquatic ecotoxicity and is derived following procedures defined in Annex F similar to those set out in the EU TGD The EU TGD has been recently incorporated in the REACH EC No 1907 2006 technical guidance on information requirements and chemical safety assessment R10 Version 7 0 1 October 2014 3 5 Safety Evaluation Finally the safety of the ingredient as used in the product being evaluated is benchmarked as a Projected Environmental Safety Ratio PESR calculated by dividing the total PEC projected category plus background by the PNEC In the concept of this risk based safety evaluation a PESR lt 1 is seen as demonstrating that the substance as used in the product is safe for the environment Because the PESR calculation projects conservative tonnage estimations as the basis for the PEC the PESR estimation is conser
27. ietary ingredients added under 5 1 above and of refinement of existing ingredients 5 2 above must be notified to A I S E using the Notification Form provided and archived This form will guide you in terms of what data must be notified depending on whether the ingredient is already in the ESC Tool or not and or what data for existing ingredients you are refining If results for all ingredients in your product formulation are Clear i e no results are red it will pass the ESC check and qualify as meeting that aspect of the ASP as soon as A I S E has ratified the data you have notified as valid for use in the ESC Tool It should be noted that when an ingredient shows red results because the approach is conservative it does not necessarily mean the substance use causes a risk to the environment see 3 5 Red results do however prevent a formulation from passing the ESC check All key data used in Stage 2 assessments for existing or newly added ingredients must be archived along with the ESC Check Form for the product 21 Version 7 0 1 October 2014 ESC MANUAL LIST OF ANNEXES gt STAGE 1 RELATED ANNEXES Annex A Ingredients exempt from the ESC Check ou ccecscsscsecsesesscssceeesceeceecseceecaeeeseeseeeaes Page 23 Annex B Spreadsheet Validation Check fictional example ceeseeceseseseceeesseeecsscseeseeees Page 24 Annex C Worked example anan nananana Page 25 gt STAGE 2 RELATED ANNEXES Annex D Hig
28. in the ESC Tool up to a maximum use level of the preparation which the supplier will declare to you again based on solid laundry products maximum dosage as a worst case assumption If the supplier confirms Unqualified Clearance your product passes the ESC check in respect of enzyme ancillary ingredients If the supplier confirms Qualified Clearance your product passes the ESC check in respect of enzyme ancillary ingredients provided that the level of use of the enzyme preparation in your formulation is no higher than the maximum level advised by the supplier In case you are using the enzyme preparation in a product category other than solid laundry you may adjust the maximum level pro rata to category 13 Version 7 0 1 October 2014 volume using the figures in Column D of the Category Data sheet normally hidden unhide with right click on the tab at the bottom of any worksheet e f the maximum use level advised by the supplier in respect of Qualified Clearance is below your use level including pro rata correction for the category you and or the supplier may discuss with A I S E whether refinement is possible e g through Stage 2 procedures 4 6 Exempt ingredients A range of substances are considered exempt from the ESC check as their properties are such that use in detergents clearly poses no risk to the aquatic environment when disposed of via sewage treatment These are generally either simple inorganics or organics exempt
29. ing of tonnage actually used in the Category b For additional ingredients not already listed in the tool Where such new estimates are needed they should be made according to the following procedure In all cases companies must satisfy themselves the estimate is appropriate or conservative for the EU 15 countries as the Tool calculations are based on the EU 15 population 370 million i e is not an under estimate Where necessary data may be extrapolated from e g EU 27 figures 500 million population or from comparable regions e g USA or from particular countries as long as care is taken to ensure the estimate remains conservative 1 A I S E industries tonnage used in cleaning products For high volume ingredients with a substantial use in cleaning products tonnage information on use in cleaning products will sometimes be available in publically available sources Because these are mostly related to overall tonnages they are listed under section 2 below 29 Version 7 0 1 October 2014 Where no data is available from public sources the Tool will assume as a default that A I S E tonnage used in categories outside the one being evaluated is the same as the projected tonnage for the category In such cases the total A I S E tonnages will be equal to twice the projected category tonnage Note that the default calculation in the Tool is to add the projected Category PEC to an estimated A 1 S E PEC which will also in
30. is disposed of down the drain but in others specific estimates are made of likely down the drain tonnages where it can be justified that not all quantities used are released down the drain For each ingredient these tonnages are then approximated in a conservative way by selection of a Factor between 1 25 and 10 that reflects the extent of likely down the drain use in other industries in relation to its use in cleaning products The estimated tonnage used in cleaning products 3 2 1 is then multiplied by this Factor and added to give a total estimate of background tonnage that is conservative and that does not need regular monitoring and updating The maximum Factor of 10 applied to use in cleaning products reflects that fact that if cleaning product use is only a few percent of total down the drain use safety is dominantly determined by uses beyond the control or influence of A I S E The derivation of tonnages and Factors is given in Annex F 3 3 PEC calculations The general assumption used for PEC calculations is that all ingredients in cleaning products are 100 discharged to sewer All down the drain emissions are considered to be subject to secondary sewage treatment For readily degradable substances a removal rate of 87 is assigned as a default to represent the minimum overall removal percentage as outlined in the EU Technical Guidance Document TGD For substances where the removal has been shown to be higher e g by higher t
31. l calculations and results depend on these two items Work from your complete product composition which lists the content of each ingredient as a percentage of the finished products For each ingredient in your formulation First identify the relevant Ingredient Number for the ingredient You can do this in one of three ways e Using the CAS Number search facility in the top RH corner of the ESC Check Form enter the CAS Number in the pale yellow box H2 The ingredient number appears in J1 and a confirmatory description in the lines below You can also access this facility on the Ingredient Search sheet e Browse the list in Column B on the Base Data sheet sheet 2 The Ingredient Number is in Column A N B The ingredients follow the order of the DID and HAD lists though some are grouped together e Use the Ingredient Search Sheet sheet 4 to browse an ingredient list filtered by the main function of the ingredient Click on the arrow in Box D16 to display a list of 11 ingredient functions Check one or more functions to display ingredients with those functions Having identified the ingredient number enter it in Column A on the ESC Check Form The spreadsheet will automatically fill in the description 10 Version 7 0 1 October 2014 e NB Do not copy paste ingredient numbers into Column A There is a check to avoid duplicate entries which copy paste can corrupt Note also that the CAS Search boxes on Sheet 1 are an inde
32. logical information of the ESC data base is tiered and derives from the following sources Scientific Literature and databases company internal data HAD data cf http www gdch de strukturen fg wasch had ableitungsregeln pdf DID data base with TGD assessment factors New data entry in ESC data base Any new substance not included in the ESC data base can be entered in a Stage 2 check For this purpose the data on acute and chronic ecotoxicity and on the fate of the substance is assessed first T he data assessinent scheme PNEC from Risk Assessment ma ves lt 1 available gt _ gt eg EU RA OECD SIDS no 2 ye Internal validated PNE ma lt gt ain available 2 UE Mm no o g ate ecotoxicity l 7 8 a Use values Assemble om accorde to avaslabbe data j HAD niles see and apply TGD o below AF s see Q below J PNE v aj 33 Version 7 0 1 October 2014 Fate The fate of a substance is assessed following the scheme of the HAD List http www gdch de strukturen fg wasch had ableitungsregeln pdf In contrast to the degradation factors DF of the DID II list which take account of biodegradation only the HAD LF values include other relevant elimination processes The specific derivation scheme of LF values expressed here as removal rates 1 LF for use in the ESC Tool is depicted in the following table Removal Rate
33. mes 100 market share of the assessed product in a broad product category instead of actual use tonnages e it considers three cumulative tonnages by product specific A I S E and EU tonnages with conservative default assumptions e it assumes 100 exposure down the drain to sewage water from A I S E use e the effects assessment is frequently based on readily available ecotoxicity data which may lead to the use of high assessment factors The ESC results are reported as ingredient specific projected environmental safety ratios PESR which follows the accepted environmental risk concept of exposure vs effects ratios PEC PNEC of the REACH Regulation EC No 1907 2006 Where the PESR for a single substance is lt 1 in stage 1 the safety margin of the use of this substance in the respective product category is considered sufficient However because of the above mentioned screening character of the ESC in stage 1 the environmental risk assessment may be refined stage 2 An indication to enter a refined higher tier risk assessment may be given by a PESR gt 1 result Higher Tier Risk Assessment stage 2 A refinement of stage 1 is generally based on additional higher tiered information on the exposure and or effects assessment of a substance Alternatively a refinement can be achieved by re assessing the product use pattern In all cases of stage 2 assessments appropriate justification should be made available on request In order to all
34. n uses These tonnages are generally considered as additional background leading to environmental exposure to surface water due to contributions from other uses than the one being assessed The tonnages of substances listed in the ESC tool have been assessed according to A I S E literature reviews For these substances background tonnages may not be refined However if a substance use can be confirmed to be more limited than proposed by A I S E e g to a specific part of an industry etc or the exposure pathways are confirmed not to lead to surface water exposure a refinement can be achieved Appropriate justification should be recorded and made available to A I S E 3 Refinement of substance fate data If new validated information on the environmental fate characteristics of a substance becomes available this information may be used to refine the environmental elimination degradation assessment of the ESC tool Such information may comprise of new results on biotic and or abiotic degradation in the environment and can replace already existing test results of the same quality Alternatively validated higher tiered test results e g from simulation tests can be used to overwrite screening information on the environmental fate of a substance 4 Refinement of substance effect data The stage 1 effects assessment of the ESC is based on ecotoxicity information made available either by public sources or by internal data provided from A I
35. nnage data should be checked as a minimum e The OECD Existing Chemicals Database http webnet oecd org hpv ui Search aspx The search facility on this web page allows to check o Whether the substance is listed as a High Production Volume chemical If an ingredient is present on this list its total use tonnage in EU15 is likely to be 1000 tpa or greater Conversely a maximum EU15 use tonnage of 1000 tpa may be assumed for any chemical not on this list A list of HPV chemicals is also available at http www oecd org dataoecd 32 9 43947965 pdf o Whether a SIDS Screening Information Data Set has been or is being assembled for the ingredient Approaching 1400 chemicals are going through the SIDS process and final reports are available for almost 800 Some broad scale tonnage estimates at least should be available in such SIDS dossiers 30 Version 7 0 1 October 2014 Substances on this list often have a link to the OECD Chem Portal http www2 oecd org eChemPortal This provides links to reports o that may exist in a variety of international chemical safety assessment programmes including the EU Existing Chemicals Database http ecb jrc ec europa eu esis index php PGM ora Reports on this database will invariably have tonnage estimates for EU use The WHO International Programme on Chemical safety IPCS database http www inchem org Broad scale tonnage estimates are often available for substances covered here e
36. of the following factors will produce according to your estimate the most likely estimate of total all industries tonnage in column L using the following rules e f other uses are likely to be more than 5 times larger in volume than the projected category tonnage in column K you should use the factor 10 in column J e f other uses are likely to be up to 5 times larger in volume than the projected category tonnage in column K use 5 in column J e f other uses are likely to be similar in volume to the projected category tonnage in column K use 2 5 in column J e f other uses are likely to be small compared to the projected category tonnage in column K use 1 25 in column J This factor may also be used where the minimum search for data specified above has yielded no information on tonnage Where no data are available and instead of conducting the minimum search the factor 10 may be used in column J as a default value 32 Version 7 0 1 October 2014 Annex F Guidance on inclusion of aquatic toxicity and removal rate data for use in the ESC Spreadsheet Tool Background The ESC data base is based on the EU Detergent Ingredient Database DID nomenclature It provides substance information on the fate and ecotoxicity per substance The substance specific information is subsequently used in a screening risk assessment to review safe use of the substance in A I S E related products Data Sources The substance specific eco
37. olumn B e Enter an aquatic PNEC in mg l for the ingredient in Column D Consult the Annex F guidance on obtaining ecotox data if necessary e Enter a removal rate as a percentage in Column E Consult the Annex F guidance on obtaining ecotox data if necessary Procedures for deriving PNECs and removal rates are described in Annex F When this data has been entered the Tool will have calculated a default PESR for the ingredient and displayed it on the front ESC Check Form This estimates the use in other A I S E categories to be the same as the projected category tonnage at 100 market share for your formulation and b estimates total use in all industries to be 10 times this If this gives a Clear not red result for this ingredient the check in respect of this ingredient is clear and you need not work further on this ingredient However this will often be a highly conservative projection and if it gives a Red result for your ingredient Column J of the ESC Check Form you can provide a more refined tonnage projection if you have relevant information you can alter either or both of the values in Cols F and J on the Base Data Sheet following the procedures outlined in Annex E Procedures for estimating ingredient tonnages for use in the ESC Spreadsheet Tool The identity of any additional non proprietary ingredients added to the Tool to qualify a product and the relevant key data used must be notified to A I S E for ratificati
38. on and for improvement extension of the Tool For an additional ingredient which is proprietary to your company only the ingredient identity and a justification of its proprietary nature need to be notified See General procedures for operation of the ESC Check http www sustainablecleaning com content_attachments documents ESC_overall_ Procedure s ver1 010ct2010 pdf When you notify a new non proprietary ingredient and the data used to A I S E and this is ratified by A I S E for use in the Tool A I S E will assign a permanent number that you should 19 Version 7 0 1 October 2014 use in future for this ingredient A I S E will enter the new ingredient number into the Tool at the first subsequent updating and will also enter the name and relevant data provided clearance is received from the owner of the data e g the supplier Similarly A I S E will issue an ingredient number for each proprietary ingredient you notify and these numbers will be added into the main numerical series by A I S E when the Tool is updated For proprietary ingredients and for new non proprietary ingredients where the data has not yet been cleared for use by all you should enter the data yourself on the Base Data sheet following any specific instructions supplied by A I S E in terms of the data to be used For an ingredient which is proprietary to another A I S E company from whom you hold a license to use the ingredient the licensor comp
39. osage of 10g task The reasons for this are twofold firstly in contrast to other categories such as laundry or automatic dishwash products where dosages per task are precisely defined and dosed in a single discrete step for the task the applied dose from a trigger spray is delivered intermittently over the period of use and depends on the area to be cleaned and the approach and habits of the user Secondly trigger spray products currently on the market in this category which comprises glass window bathroom kitchen and all purpose cleaners are ready to use products having broadly similar concentrations of active ingredients 14 Version 7 0 1 October 2014 In most other categories it is important that PESR calculations are adjusted according to the dosage used per task This is because concentrated products have higher concentrations of ingredients than dilute products but are used at correspondingly lower dosages For trigger sprays which have broadly similar concentrations and application rates such adjustment is not important In any case defining the amount currently used per task in practice is difficult because it varies according to the area being cleaned and use habits A usage rate of around 10g m has been established through studies as a typical maximum application rate for trigger sprays when cleaning small areas rates being lower when larger areas are being cleaned Consequently the current average dose for trigg
40. ow a continuous improvement of the ESC non proprietary information shall be reported to A I S E for further review separately documented In total there are five options offering potential for refinement of the ESC stage 1 PEC Predicted Environmental Concentration PNEC Predicted No Effect Concentration 26 Version 7 0 1 October 2014 1 Refinement of category tonnage on account of specialised use or function Where an ingredient has a special activity and is used to provide the product with a particular specialised function or niche use that is not a feature of most products in the category the generic assumptions of broad product categories are not representative They would substantially over predict real consumption and hence exposure pattern In such cases the projected category tonnage may be refined by considering a lower per capita usage which reflects only that proportion of the total category market that comprises products with the specialised use or function The lower per capita usage assumption should cover the entire market for such products i e assuming the formulation commands 10096 market share and be backed up by market data and or tonnage information e g from market surveys 2 Refinement of background tonnage Beyond the product category tonnage projections stage 1 also considers the use of a substance both in additional A LS E product categories and outside the A I S E industries in down the drai
41. pendent search facility and not linked to ingredient entries e On the same line on the ESC Check Form in column C enter the percentage content of the ingredient The spreadsheet will then fill in additional data depending on whether the ingredient is exempt from PESR calculation or not e NB For non HERA ingredients it is important for a valid ESC Check that the percentage content of ingredients is entered as the content of the active anhydrous substance excluding any water or inactive components of a preparation e In the cases specified below the content must be expressed in the correct chemical form e g as salts or acid This is because the aquatic toxicity data on which the PESR calculation depends is expressed in such a specific way e Express NTA as trisodium salt and EDTA as the acid Note that if your formulation contains two similar ingredients which both have the same Ingredient Number you must enter the Ingredient Number just once and add the contents together If you do enter the same ingredient number twice it will be highlighted in red to alert you so you can correct the double entry 4 2 Ingredients with allocated Numbers but no data displayed in the Tool In certain circumstances you may have been supplied with ingredient numbers for ingredients you have notified but the ingredient name and other data on the Base Data sheet are blank This can arise either a When the ingredient is proprietary to your own or anothe
42. quent than monthly It is important always to use the latest version of the ESC Tool appearing on the website when conducting a Check Version 7 0 1 October 2014 3 Calculations performed by the ESC Tool The ESC Tool provides a simple mechanism with which companies can demonstrate safety of individual cleaning products that they wish to qualify as meeting the ASP for Charter Update 2010 For ingredients for which published scientific risk assessments e g EU Existing Chemicals programme and HERA conducted to standards similar to those set out in the EU Technical Guidance Document REACH are available and reach a conclusion of no concern for the aquatic environment that would be valid for its use in the product being checked environmental safety of the ingredient is already demonstrated and the ESC Tool directly assigns a clear result RA OK Similarly for certain ingredients unlikely to pose any risk to the aquatic environment e g those listed in Annexes IV and V of REACH covering exemptions from registration and some simple salts of inorganic ions that are ubiquitous in sewage flows see Annex A the ingredient is exempt from further checking For all other ingredients the tool performs calculations based on the core concept of aquatic risk assessment it conservatively projects Predicted Environmental Concentrations PEC that could conceptually arise in the aquatic environment and compares these to relevant Predicted No Effect
43. r company in which case only the owning company and any licensees will have the details b When the data for a non proprietary ingredient has been ratified by A I S E but clearance has not yet been received from the owner of the data e g the supplier to include the data in the Tool for use by all To use the Tool for such ingredients you will need to enter the data yourself on the Base Data sheet as follows The relevant cells will be left unprotected to allow you to do this a Fora proprietary ingredient which you own or use under license enter your own data or that supplied to you by the licensor b For a non proprietary ingredient ratified by A I S E but not yet included in the public Tool add the data as ratified by A I S E following any specific instructions supplied 11 Version 7 0 1 October 2014 4 3 Perfumes To pass the ESC Check in respect of fragrance compounds included in the formulation you must obtain confirmation from your supplier that a the supplier complies in all respects concerning the manufacture handling and supply of the fragrance with the IFRA Code of Practice http www ifraorg org en us code of practice 1 and b that the fragrance compound complies with all IFRA standards relating to potential environmental risks in respect of all its constituents http www ifraorg org en us standards 1 Perfumes for which you have such confirmation from your supplier s may be entered as Ingredient 142 Perf
44. rate entered refined value as 96 in the Base data Sheet Column E e Background tonnage o Refined A I S E tonnage enter in the Base data Sheet Column F 20 Version 7 0 1 October 2014 o Category A I S E enter in the Base data Sheet in the relevant column G I for the category o Refined Total A I S E factor enter in the Base data Sheet Column J e Category tonnage o When the category tonnage projection is to be modified for one or more ingredients in accordance with Option 1 in Annex D because the product has a specialised function or niche use it is not possible to amend per capita usage directly Instead the check will be done by reducing the content of the ingredient s pro rata according to the fraction of the whole category market that the specialised use represents Thus complete and archive an ESC check for the formulations as normal Some ingredients will have red results clear the ESC Check Sheet and enter again using the reduced content just the ingredients showing red results Archive these check sheet results to override the red results in the previous check NB You should continue to treat the ingredient in this way until the Tool is updated to include the revised data This process can also be applied to additional ingredients added to the tool where data initially used needs to be further refined 5 3 Notification and Ratification Relevant key data in respect of additional non propr
45. ry PEC is derived from an estimate of the total market per capita for products of that type For current ASP product categories this is derived from statistics published by the IKW for Germany which is considered a mature and stable market in terms of per capita consumption Data from Germany should provide a conservative model for the EU in general Consumption is expressed in tasks per capita per year e g number of washes per capita per year based on an average product dose so that more efficient concentrated products which perform each task using lower dosages and thus a lower ingredient load are properly credited with that load reduction The tool calculates a conservative per capita release for each ingredient per day based on the formulation and dosage using conservative market share assumptions 3 2 Background Tonnage 3 2 1 A 1 S E tonnage projection There are two alternative conservative approaches to estimating substance release from other cleaning product categories a A I S E tonnage available the background PEC arising from use in other types of cleaning products is derived from use tonnage estimates taken from published literature or A I S E internal sources where available This tonnage is taken to be the background down the drain emission of A I S E uses In cases where the contribution of a specific category to the total A I S E tonnage is known there is a facility to assign this value in order
46. sion HAD Hauptausschuss Detergenzien a body of the German society of Chemists GdCh Version 7 0 1 October 2014 e Ingredients 210 to 225 are generic headings for colourants depending on their environmental classification and removal in sewage treatment e There then follow a number of additional ingredients which companies have notified as being used in the current ASP product categories In some cases there will be no details against the ingredient number either permanently because they are proprietary or temporarily while awaiting supplier clearance to publish the data e Below these under the heading Additional or refined ingredients are empty rows for individual companies to use in Stage 2 checks prior to ratification to add ingredients used but not yet on the list or to make refined entries for already listed ingredients Note that all sheets are protected so that only unlocked cells can be selected or altered This is to avoid inadvertent alteration and corruption of results Thus where data for a listed ingredient are refined the full set of data for the ingredient should be re entered as a new ingredient in one of the empty rows Updating of the ESC Tool is carried out by an Expert Panel of A I S E on a continual basis Updates will be uploaded periodically to the ESC Tool to amend data for listed ingredients when necessary and to add new ingredients to the list Such updates will not be more fre
47. uld be documented in a way that shows for auditing purposes that the colourants are chemically different and that both have been considered for example by archiving separate checks using the level of each colourant in turn or by checking only the colourant with the highest level and noting separately the presence of the other A table correlating Colour Index Numbers to chemical type is available at http en wikipedia org wiki Colour Index International 4 5 Enzymes The active ingredients enzyme proteins of enzyme preparations used in detergents automatically pass the ESC check on the basis of the HERA risk assessments for these substances However enzyme preparations include various other ancillary ingredients such as carriers stabilizers encapsulants etc Known enzyme suppliers have been contacted and they have agreed to assist the ESC checking of enzyme preparations using the approach set out in Annex G Accordingly to pass the ESC Check in respect of enzyme preparations included in the formulation you must obtain confirmation from your supplier that EITHER a the enzyme supplier confirms Unqualified Clearance of all ingredients in the preparation following a check of each ingredient in the ESC Tool at maximum notified use levels using solid laundry products at maximum use dosage as a worst case assumption OR b the enzyme supplier confirms Qualified Clearance of all ingredients in the preparation following a check of each ingredient
48. ume IFRA Standards Compliant This is exempt from calculation 4 4 Colourants The ESC Tool contains 16 generic ingredient numbers for colourants Nos 210 225 covering the matrix of 4 possible levels of acute aquatic toxicity denoted R50 R51 R52 and NC Not Classified and 4 removal rates O 25 60 80 Removal rates were derived from calculated lg Kow values and or estimated at 80 for pigment dyes You can select the appropriate ESC ingredient number for a colourant as follows 1 Enter the CAS Number of your colourant in the Ingredient Search sheet A6 In case of a match the C I name of the colourant appears A10 and you are asked A8 to move to the right hand colourants box for further input 2 In cell B6 select from the drop down list the appropriate environmental classification as regards acute aquatic toxicity R50 R51 R52 or NC of the colourants This information should be readily available from the material safety data sheet Cell B13 in the dye box gives the removal rate based either on a log Kow that was calculated by EPIWIN default 0 or estimated at 80 for pigment dyes 7 R50 R51 R52 and NC are used here as shorthand to indicate substances with an aquatic L E C50 of lt 1mg l 1 lt gt 10mg I 10 lt gt 100mg I and gt 100mg I respectively though R51 and R52 are not indicated as standalone classifications on safety on data s
49. vative often highly so Therefore a PESR gt 1 does not necessarily mean there is a risk for the environment For ease of reference PESR values on the ESC Check Sheet are colour coded e Ingredients coloured Green have a PESR below 0 5 Clear result e Ingredients coloured Amber have a PESR between 0 5 and 1 Clear result e Ingredients coloured Red have a PESR 51 PESR calculations based on the projected category PEC and on the total use in cleaning products A 1 S E PEC are also provided on the ESC Check Sheet for information only Stage 1 use of the ESC Tool is effectively a conservative screening check This can be refined where necessary in a Stage 2 check following the procedures of higher tiered risk assessment set out in Annex D 3 6 Worked example A worked example of how the spreadsheet does the calculation is provided in Annex C of this Manual Version 7 0 1 October 2014 4 How to use the ESC Tool Stage1 NOTES 1 Since complex Excel spreadsheets can occasionally become corrupted e g during electronic transmission or behave slightly differently on different computers according to the software etc please carry out the following quick Validation Check You can repeat this validation check at any time if you suspect the Tool has become corrupted or is otherwise malfunctioning Enter the numbers in the first and 3 columns of the fictitious Validation example Annex B into Columns A and C of the E
50. with Cl SO OH CO SiO HCO3 NO SO Relevant examples include Magnesium chloride hydrochloric acid e Ingredient 209 Any organic substance exempted from REACH registration through listing on Annexes IV and V of REACH Commission Regulation EC No 987 2008 http eur lex europa eu LexUriServ LexUriServ do uri OJ L 2008 268 0014 0019 EN PDF Relevant examples include Coconut oil 23 Version 7 0 1 October 2014 Annex B Spreadsheet Validation Check fictional example Kan Company Product Name Product Category drop down list Formulation Date Recommended product dosage g use enter CAS and cell J2 will return Ing where available PESR PESR FEES Ingredient wiw in Formulation Total ESC Result All Inds Jainytsupnates as TT HRW OK Jc 14 76 ara Olefin sulphonate w0 gaga aaa 0 2482 censa zoaeo f s ago onajon onen c Bre or c12 14 Ayi polygycosaes s f ozsa 02563 0 2e0 0 2880 oo HERA OK Category Total AISE Polycarboxylates HERA OK E0DS 0 0060 0 0067 0 0079 0 0079 Polyasparaginic acid Na salt_ 10TH 01982 0 2077 0 2011 Carboxymethylcellulose CMC 2 03528 Polyethylene glycol MW gt 4000_ T0853 oosss 03352 0 3352 starch a a paaa d f Exempt Zn Ftalocyanin sulphonate 1 0290 ws TI gt tt 1 a Dipropylene glycol CT 5 ooz 0 0238 0 0265 0 0265 0 1180 Enzymes Protease Amylase Cellulase Lipas 7 ll
Download Pdf Manuals
Related Search