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User Manual - European Commission

1. METHYL ESTER ESTERS SULPHONATES IPP IPM EGDS etc MES ALKANOLAMIDES CMEA CDEA FATTY ISETHIONATES SCI ALCOHOL ALCOHOL SULPHATES ETHOXYLATES SLS AEO NI BETAINES CAPB QUATERNARY ETHER SURFACTANTS SULPHATES ETAC SLES ALES Palm Oil and Palm Kernel Oil Derivatives are those that contain a majority of C8 C18 C Chains Products with other dominant C Chains gt C18 are out of scope as they will not be derived from palm and palm kernel oil The scope has been limited to the major primary and secondary Oleochemicals and their derivatives to minimize complexity Fatty Acid Methyl esters Fatty Alcohols If the C Chain distribution is gt 65 in the range C8 C14 the derivative shall be considered to be produced from palm kernel oil If the C Chain distribution is gt 95 in the range C16 C18 the derivative shall be considered to be produced from palm oil Other C Chain length distributions shall be considered as derived from a blend of palm and palm kernel oil their raw material reference shall be palm oil Fatty Amines Tertiary Amines shall be considered to be derived from palm kernel oil reflecting their primary production from Fatty Alcohol C1214 Primary Amines shall be considered in line with Fatty Acids and Methyl esters Version 1 0 Page 72 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics
2. 3 Readily degradable and non bioaccumulating Please complete the table below to show actual aNBO and anNBO values for the product Product aNBO anNBO please specify e g shampoo mg g AC mg g AC Except where the substance is on the DID list please attach additional information to support the claims made against each organic ingoing substance Guidance for this is provided in Appendix Testing for adsorption desorption may be conducted in accordance with OECD guidelines 106 Version 1 0 Page 42 of 77 ie uve EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Ecolabel Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Declaration Criteria 3 a Specified excluded ingoing substances and mixtures Applicant For the following product formulation ceccssssssussssssssssscscssscsssssssesmenssesesssisssssseussescsssesmssssssessssesssensussescsesssiesesssesees the undersigned hereby declare that the following ingoing substances and mixtures have not been included in the product neither as part of the formulation nor as part of any mixture included in the formulation i Alkyl phenol ethoxylates APEOs and other alkyl phenol derivatives ii Nitrilo tri acetate NTA iii Boric acid borates and perborates iv Nitromusks and polycyclic musks v Octamethylcyclotetrasiloxane D4 vi Butylated Hydroxi Toluene BHT vii Ethylenediaminetetraacetate EDTA and it
3. EU Ecolabel rinse off cosmetic products European Commission EU Ecolabel rinse off cosmetic products te VE EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Ecolabe www ecolabel eu USING this MANUAL 3 Part A General INFOMMATI ON 5 1 INtrOCUEtion ili ii 5 11 Is my product eligible for the EU EcolabeP ssumsmsessssstttitititiatittisisitutiitisstitissssisssssnss 5 12 Aims of the critena iecdsccctacsne enone eterna cara nbn thas i lero cet teins 5 13 Who can apply for the EU Ecolabel wc ssesasssssssssstsnsstatestntstintstsntntsneststntistnsstsneetsteniststenisteeunteneessensee 6 14 Where do Tappy Pee ere ver a rA POV ROR oO Pe 6 15 What does an application CONtract COVER 6 16 How do extend or make changes to My EU Ecolabel ICON CE ememsmemmenenemmeneenentnienntneninietse 6 17 Continuous control the responsibility Of the appliCant ue ie 7 18 19 2 Theapplicaton Proce S S ses cs cccscicsssnedncnsesetr E A R 8 Step ECAT registration alal eil iena 9 Step 2 Information testing and verification reQUIFEMENKS ecemsmsmesenesmuttttittiitiatisieiisisiitinisinininunsinus 9 Step 3 Compile and submit dossier and application form 9 Step 4 ASSeSSMEN Ensaios ni iii 9 Step Well sh Li CR CO ranita er e aa 10 Revision orEentena acri 10 Checklist How t0 ApplVi dille 11 Definitions
4. 2014 893 EU Appendix IV Guidelines for fitness for use testing The product s capacity to fulfil its primary function e g cleaning conditioning and any secondary functions claimed e g anti dandruff colour protection shall be demonstrated either through laboratory test s ora consumer test Both consumer and laboratory tests shall be conducted following the Guidelines for the Evaluation of the Efficacy of Cosmetic Products available for download here https www cosmeticseurope eu publications cosmetics europe association quidelines html view item amp id 23 1 If a consumer test is employed the following guidelines must be followed A consumer test shall be done in anonymous conditions i e the name of the market leading product which will be used as reference products shall not be disclosed For auto evaluation tests blind use tests shall be used as described in the Guidelines for the Evaluation of the Efficacy of Cosmetic Products Chapter 1 1 A consumer test must include as minimum of 15 people The consumers must be asked about the product s efficiency compared to a market leading product The questions to the consumers must cover at least the following aspects 1 How well does the product perform in comparison with the market leading product 2 How easy is it to apply the desired dosage of the product in comparison with the market leading product 3 How easy is it to apply and rinse off the product to
5. Ecolabel for rinse off cosmetics 2014 893 EU Declaration 3 f Colorants Applicant For the following product formulation iiii the undersigned hereby declare that colorants are are not added please delete as appropriate Where they are added they are listed below and declare that they are not bioaccumulating Note A colorantis considered not bioaccumulating if BCF lt 100 orlogKow lt 3 0 If both BCF and logK y values are available the highest measured BCF value shall be used In the case of colouring agents approved for use in food it is not necessary to submit documentation of bioaccumulation potential Where applicable please attach documentation demonstrating that the colorants are approved for use in food Version 1 0 Page 55 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Declaration 4 a Primary packaging Applicant For the following product formulation iii the undersigned hereby declare that primary packaging is in direct contact with product contents I also confirm that no additional packaging for the product e g carton over a bottle is used with the exception of secondary packaging which groups two or more products together e g the product and refill Version 1 0 Page 56 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Deci
6. IFRA website http Awww ifraorg org The recommendations of the IFRA Standards concerning prohibition restricted use and specified purity criteria for materials shall be followed by the manufacturer Version 1 0 Page 24 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU www ecolabel euw Required documentation for Assessment and verification Fragrances ini The applicant shall provide a signed declaration of compliance supported by a declaration of the fragrance manufacturer as appropriate ini Declaration Fragrances ini Supplier Declaration Fragrances Interpretation of criteria The IFRA code of practice can be found at http admin ifra alligence com Files Documents 1 en us GD 22156 GD 2006 12 15 IFRA Code of Practice Body amp 8 Appendices Dec 2006 pdf Specific information on how fragrances should be manufactured and handled can be found under appendix 6 IFRA Recommendations for Good Operating Practice A list of prohibited and restricted substances can be found here http www ifraorg org en standards 3 e Preservatives i Preservatives in the product shall not release or degrade to substances that are classified in accordance with the requirements of criterion 3 b ii The product may contain preservatives provided that they are not bioaccumulating A preservative i
7. Page 50 of 77 ves uve EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Ecolabel Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Declaration 3 c Ingoing substances listed in accordance with Article 59 1 of Regulation EC No 1907 2006 Supplier the undersigned as a supplier of the following ingoing substances raw materials hereby declare that these ingoing substances are not identified as substances of very high concern and included in the list provided for in Article 591 of Regulation EC No 1907 2006 Signature of person bearing legal responsibility Company Stamp Version 1 0 Page 51 of 77 ves uve EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Ecolabel Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Declaration 3 d Fragrances Applicant For the following product formulation iii the undersigned hereby declare that i Products marketed as designed and intended for children do not contain fragrances ii Ingoing substance or mixture added to the product as a fragrance are manufactured and handled following the code of practice of the International Fragrance Association IFRA Company Stamp Version 1 0 Page 52 of 77 ie uve EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Ecolabel Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Dec
8. RSPO in the RSPO Rules for Home and Personal Care Derivatives available at http www greenpalm org upload files 45 RSPO Guiding Rules for HPC derivativesV9 pdf Version 1 0 Page 32 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Criterion 6 Fitness for use The product s capacity to fulfil its primary function e g cleaning conditioning and any secondary functions claimed e g anti dandruff colour protection etc shall be demonstrated either through laboratory test s or a consumer test The tests shall be conducted following the Guidelines for the Evaluation of the Efficacy of Cosmetic Products Required documentation for Assessmentand verification Fitness for use B The applicant shall document the test protocol that has been followed in order to test the product s efficacy Applicants shall present results from this protocol that demonstrate that the product fulfils the primary function and secondary functions claimed on the product label or packaging B Declaration Fitness for use Interpretation of criteria v The Guidelines for the Evaluation of the Efficacy of Cosmetic Products is available to download here https www cosmeticseurope eu publications cosmetics europe association quidelines html view item amp id 23 See Appendix IV for additional guidance for fitness for use testing Version 1
9. calculated as follows F VxR Vrefill Where V volume capacity of the parent pack ml Vrefill volume capacity of the refill pack ml R the refillable quantity This is the number of times that the parent pack can be refilled Where F is not a whole number it should be rounded up to the next whole number In case no refill is offered PIR shall be calculated as follows PIR W N D The manufacturer shall provide the number of foreseen refilling or use the default values of R 5 for plastics and R 2 for cardboard Interpretation of criteria The Packaging Impact Ration PIR should be calculated as gram of packaging per gram of product The applicant shall provide evidence on the expected number of refills of their packaging where appropriate and not use the default values Required documentation for Assessment and verification Packaging Impact Ratio The applicant shall provide the calculation of the PIR of the product A spreadsheet for this calculation is available on the EU Ecolabel website If the product is sold in different packaging i e with different volumes the calculation shall be submitted for each packaging size for which the EU Ecolabel shall be awarded The applicant shall provide a signed declaration for the content of post consumer recycled material or material from renewable origin in the packaging and a description of the refill system offered if applicable kinds of refil
10. deriving the data for the calculations of the Critical Dilution Volume CDV and for the assessment of the biodegradability of the ingoing substances For substances not present on the DID list guidance is given on how to calculate or extrapolate the relevant data The latest version of the DID list is available from the EU Ecolabel website or via the websites of the individual competent bodies http ec europa eu environment ecolabel documents did_list didlist_part_a_en pdfhttp ec europa eu en vironment ecolabel documents did_list didlist_part_b_en pdf Version 1 0 Page 13 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU www ecolabel euw b Measurement thresholds Compliance with the ecological criteria is required for all ingoing substances with the exception of compliance with criterion 3 b and 3 c for preservatives colorants and fragrances which is requested when their concentration equals or exceeds 0 010 by weight in the final formulation The following information shall be provided to the Competent Body i The full formulation of the product indicating trade name chemical name CAS number and INCI designations DID number the ingoing quantity including and excluding water the function and the form of all ingredients regardless of concentration ii Safety data sheets for each ingoing substance or mixture i
11. for each surfactant As the supplier of the following surfactant of a rinse off cosmetic product s I the undersigned declare that The product contains palm oil and or palm kernel oil YES NO please delete as appropriate The amount of palm palmkernel oil carbon content of the total carbon is in The palm oil and or palm kernel oil is Identity Preserved Segregated Mass balance not certified please delete as appropriate The certification scheme is RSPO OTHER please delete as appropriate If Other the certification scheme is Version 1 0 Page 65 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU Declaration Criterion 6 Fitness for use Applicant I the undersigned hereby declare that the rinse off cosmetic is fit for use i e that the product fulfils the primary and secondary functions claimed on the product label or packaging The products fitness for use is demonstrated by please tick all applicable LU Laboratory test performed by the producer U Laboratory test performed by test institute U Consumer test The information below provides details and results of the test protocol used to verify this fitness for use Please see Appendix IV of this User Manual for details of fitness for use testing oe Any test reports results should be attached to this declaration Version 1 0 Page 66
12. for rinse off cosmetics 2014 893 EU Part B Product assessment and verification 1 Product group criteria Criteria for awarding the EU Ecolabel to rinse off cosmetic products are Toxicity to aquatic organisms Critical Dilution Volume CDV Biodegradability Excluded or limited substances and mixtures Packaging Sustainable sourcing of palm oil palm kernel oil and their derivatives Fitness for use NOWRA WNE Information appearing on the EU Ecolabel 2 Assessment and verification a Requirements The specific assessment and verification requirements are indicated for each criterion Where the applicant is required to provide declarations documentation analyses test reports or other evidence to show compliance with the criteria these may originate from the applicant or his supplier s or both Where possible the testing shall be performed by laboratories that meet the general requirements of European Standard EN ISO 17025 or equivalent Where appropriate test methods other than those indicated for each criterion may be used if the competent body assessing the application accepts their equivalence Where appropriate competent bodies may require supporting documentation and may carry out independent verifications The Appendix makes reference to the Detergent Ingredient Database list DID list which contains the most widely used ingredients used in detergents and cosmetics formulations It shall be used for
13. of 77 ie uve EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Ecolabel Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Declaration Criterion 7 Information appearing on the EU Ecolabel Applicant the undersigned hereby declare that am am not delete as appropriate using the optional label box If used declare I am using it in accordance with the EU Ecolabel logo guidelines and the following texts e Reduced impact on aquatic ecosystems e Fulfils strict biodegradability requirements e Limits packaging waste Please provide the artwork or samples of the packaging svn eee Company Stamp Version 1 0 Page 67 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Appendix l DID list The DID list Part A is a list containing information of the aquatic toxicity and biodegradability of ingredients typically used in detergent formulations The list includes information on the toxicity and biodegradability of a range of substances used in washing and cleaning products The list is not comprehensive but guidance is given in Part B of the DID list conceming the determination of the relevant calculation parameters for substances not present on the DID list e g the Toxicity Factor TF and degradation factor DF which are used for calculation of the critical dilution volume The li
14. the product residue divided by mass of product in the container 2 Measurements Measurements aim at determining precisely the mass of product and packaging Measurements are adapted to each product based on the characteristics of the packaging and are defined in dedicated specifications The following masses are measured K Primary packaging and product m1 g K Primary packaging and product residue in normal conditions of use see below m2 g X Primary packaging emptied and cleaned m3 g 3 Results From previous measurements we have The mass of product in the container Mprodut M1 m3 X The mass of product residue in normal conditions of use Version 1 0 Page 70 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Mresidues M2 m3 We deduce R m2 m3 m1 m3 x 100 Normal conditions of use X Tube Applying for three minutes successive pressures on the body of the primary packaging in direct contact with the cap in downward position The test is considered complete when no amount of liquid will flow after five successive pressures on the body of the primary packaging in direct contact Neither the cap is dismantled nor water is introduced inside the packaging K Spray Applying successive pressures on the tip of the spray by pressing the spring down entirely Wait until the spring has returned to its initial position prio
15. 0 Page 33 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Criterion 7 Information appearing on the EU Ecolabel The optional label with text box shall contain the following text Reduced impact on aquatic ecosystems Fulfils strict biodegradability requirements Limits packaging waste The guidelines for the use of the optional label with text box can be found in the Guidelines for use of the Ecolabel logo on the website http ec europa eu environment ecolabel documents logo_quidelines pdf Required documentation for Assessment and verification Information appearing on the EU Ecolabel M The applicant shall provide a sample of the product label or an artwork of the packaging where the EU Ecolabel is placed together with a signed declaration of compliance ME Declaration Information appearing on the EU Ecolabel Version 1 0 Page 34 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU Part C Application Form A Please contact your Competent Body to learn how your completed application form and supporting documentation should be submitted See section 1 4 in Part A Where do apply for further details of where to send your application once completed AN Applicants should also provide a tec
16. 14 893 EU Regulation EC No 66 2010 following application of Article 6 7 of the same Regulation Table 4 Derogated substances Substances Hazard statements Risk phrases Surfactants in total concentrations lt 20 in the final product H413 May cause long term adverse effects to aquatic life R53 H412 Harmful to aquatic life with long lasting effects R52 53 H412 Harmful to aquatic life with long lasting effects Fragrances H413 May cause long term adverse effects to aquatic life Preservatives H411 Toxic to aquatic life with long lasting effects H412 Harmful to aquatic life with long lasting effects H413 May cause long term adverse effects to aquatic life Zinc pyrithione ZPT used in anti dandruff H400 Very toxic to aquatic life shampoos Derogation is only for criterion 3 b Fragrances shall comply with crite rion 3 d Derogation is only for crite rion 3 b Preservatives shall comply with crite rion 3 e Required documentation for Assessment and verification Hazardous substances and mixtures ini The applicant shall demonstrate compliance with criterion 3 b for any ingoing substance or mixture present at concentrations greater than 0 010 in the final product ini A declaration of compliance shall be provided by the applicant supported where appropriate by the declarations from producer s of the raw materials that none of these ingoing substances and or mixtures mee
17. L Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU wwwr ecolabel eu Declaration 4 d Design for recycling of plastic packaging Applicant For the following product fornulation ss sirsrersimienien enana a ara ea AE ANE ERAN E i I the undersigned hereby declare that the plastic packaging is designed to facilitate effective recycling It avoids potential contaminants or incompatible materials that are known to impede separation or reprocessing or to reduce the quality of recyclates The label or sleeve closure and where applicable barrier coatings do not comprise the materials or components listed in Table 5 of the criteria document Pumps and aerosol containers are exempted from this requirement Please provide details of the packaging including a sample Component Material and additional details Note the following must notbe part of the labelorsleeve elements PS label or sleeve incombination material used with a PET PP or HDPE bottle PVC labelorsleeve incombination witha PET PP or HDPE bottle PETG label orsleeve in combination witha PET bottle Sleeves made of different polymer than the bottle Labels orsleeves that are metallised or are welded to a packaging body in mould labelling Note the following must not be part of the closure elements PS closure in combination a with a PET PP or HDPE bottle PVC closure incombination witha PET PP or HDPE bottle PETG closu
18. Li Regulation EC No 1907 2006 of the European Parliament and of the Council of 18 December 2006 conceming the Registration Evaluation Authorisation and Restriction of Chemicals REACH establishing a Europe an Chemicals Agency amending Directive 1999 45 EC and repealing Council Regulation EEC No 793 93 and Commission Regulation EC No 1488 94 as well as Council Directive 76 769 EEC and Commission Directives 91 155 EEC 93 67 EEC 93 105 EC and 2000 21 EC OJ L 396 30 12 2006 p 1 Version 1 0 Page 45 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU www ecolabel euw Declaration Criteria 3 b Hazardous substances and mixtures Part B Applicant For the following product formulation iii the undersigned hereby declare that unless specifically derogated all ingoing substances are compliant with criterion 3 b in that they are not classified with one or more of hazard statements or risk phrases listed in Table 3 in the form s and physical state s they are present in the product I declare that have collected all necessary information from my suppliers and calculated respective concentrations of the classified substances in the final product NOTE The following technical information related to the form s and physical state s of the ingoing substances and or mixtures as presentinthe product shallbe providedto
19. Part B Product ASSESSMENT and Verification 13 1 PIOAUCtGIOUP Criterna crioi oi i 13 2 ASSESSMENT and Verification 13 a Reguiremenis ac ici 13 b Measurement threshold iii 14 Version 1 0 Page 1 of 77 ce VE EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Ecolabe Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU www ecolabel eu Criterion 1 Toxicity to aquatic organisms Critical Dilution VOLUME CDV u nsssustisssuttintitisisiesseen 15 Criterion 2 Biode grad ability i 17 2 a Biodegradability of Surfactants iii 17 2 b Biodegradability of organic INGOING SUDSTANCES ecmnemennenemenenemmeememeeuineeeeineenitt 17 Criterion 3 Excluded or limited substances ANd MIXtUIES emcee 19 3 a Specified excluded ingoing substances and MIXtULES emmmmcnemneneeneemmeeeeenenanenienieeniinttitse 19 3 b Hazardous substances and MIXtUPES nemesis 19 3 c Ingoing substances listed in accordance with Article 59 1 of Regulation EC No 1907 2006 23 3 0 Fragrance Soar a E a E A O EEO 24 S 2 PIESETVALIVES c lille 25 SifGoloranis ai 26 Criterion 4 Packaging areali 27 4 a Primary packaging 4 b Packaging Impact Ratio PIR 27 4 c DESIGN of primary packaging 29 4 d Design for recycling of plastic PACKAGING eect 30 Criterion 5 Sustainable sourcing of palm oil palm kernel oil and their derivatives 32 Criterion 6 Fitness for USE aa ii 33 Criterion 7 Inf
20. Service ECAS system If you have any problems using the system contact your Competent Body or the Ecolabel Helpdesk Step 2 Information testing and verification requirements Use the criteria document and the information and checklists in this User Manual to assemble a dossier containing all the information and test results needed to show how the product has met each criterion Each criterion will include a section setting out the Assessment and verification requirements which may include product tests declarations of compliance or independent verification It is essential that data is accurate and substantiated further checks may be carried out by the Competent Body if deemed appropriate A All test and independent verification costs must be met by the applicant You should factor in these costs before you decide to apply Step 3 Compile and submit dossier and application form Please note that a dossier comprising an application form with all the above supporting documentation including the filled in calculation spreadsheet http ec europa eu environment ecolabel documents Calculation 20Sheet 20cosmetics xlsx will need to be submitted to the relevant Competent Body If your application is successful you will be expected to retain a copy of the dossier and keep it up to date for the duration of your licence A Send all of the documents required typically a completed and signed copy or copies of the application form the fil
21. Version 1 0 Page 76 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Description of test protocol and relevant test results Declaration Fitness for use Li Criterion 7 Information appearing on the EU Ecolabel Documents to be submitted to the Competent Body apply Sample of the product label or packaging artwork Declaration Information appearing on the EU Ecolabel a Version 1 0 Page 77 of 77
22. a PET PP or HDPE bottle PVC label or sleeve in combination with aPET PP or HDPE bottle PETG label or sleeve in combination with a PET bottle Sleeves made of different polymer to the bottle Labels or sleeves that are metallised or are welded to a packaging body in mould labelling PS closure in combination with aPET PP or HDPE bottle PVC closure in combination with a PET PP or HDPE bottle PETG closures and or closure material with density of above 1 g cm in combination with a PET bottle Closures made of metal glass EVA Closures made of silicone Exempted are silicone closures with a density lt 1g cm in combination with a PET bottle and silicone closures with a density gt 1g cm in combination with PP or HDPE bottle Metallic foils or seals which remain fixed to the bottle or closure after the product has been opened Polyamide EVOH functional polyolefins metallised and light blocking barriers A Pumps and aerosol containers are exempted from this requirement Label or sleeve Closure Interpretation of criteria Barrier coatings are thin films that provide a specific property to a container For example very thin aluminium can be used to block light or reduce gas permeability of plastic 1 EVA Ethylene Vinyl Acetate EVOH Ethylene vinyl alcohol HDPE High density polyethylene PET Polyethylene terephtalate PETG Polyethylene terephtalate glycol modified PP Polypropylene PS Polystyrene PVC Pol
23. able managed plantations Certifications accepted shall include RSPO by identity preserved segregated or mass balance or any equivalent scheme based on multi stakeholder sustainable management criteria For chemical derivatives of palm oil and palm kernel oil it is acceptable to demonstrate sustainability for these through book and claim systems such as GreenPalm or equivalent ME Declaration Sustainable sourcing of palm oil palm kernel oil and their derivatives ini Supplier Declaration Sustainable sourcing of palm oil palm kernel oil and their derivatives Interpretation of criteria Palm oil is pressed from the flesh of the fruits of the oil palm tree Palm kernel oil is produced from the kernel or stone of the fruit of the oil palm tree Derivatives Further processing of the palm oil and palm kernel oil can produce a range of derivatives and fractions See definition and scope at Appendix III The Roundtable of Sustainable Palm Oil RSPO A not for profit organisation that was set up to promote the production and use of sustainable palm oil It has members from producers retailers manufactures and NGOs Green Palm is a system by which manufacturers that use palm oil can purchase certificates from RSPO certified plantations and thus support the production of sustainable palm oil It removes the need to source specific plantations and control the sustainable palm oil supply chain la As defined by the
24. al criteria for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU A copy of the criteria can be found at v Oo http ec europa eu environment ecolabel products groups and criteria html A Please read the criteria document carefully before filling in the application form 1 1 Is my product eligible for the EU Ecolabel The product group rinse off cosmetic products is diverse with different products distinguishable according to their function content user and effects It comprises any rinse off substance or mixture falling under the scope of Regulation EC No 1223 2009 of the European Parliament and of the Council on cosmetic products intended to be placed in contact with the epidermis and or the hair system with a view exclusively or mainly to cleaning them toilet soaps shower preparations shampoos to improve the condition of the hair hair conditioning products or to protect the epidermis and lubricate the hair before shaving shaving products The product group Rinse off cosmetic products includes products for both private and professional use 1 2 Aims of the criteria The EU Ecolabel seeks to minimise the various environmental impacts at each stage of a product s life The criteria are set at levels that promote products which have a lower overall environmental impact In particular the criteria aim to e Promote the sustainable sourcing of materials e Limit the use of hazardous substances e M
25. ate the ultimate anaerobic degradability of structurally related surfactants Where anaerobic biodegradability has been confirmed for a surfactant or a group of homologues according to the DID list it can be assumed that a similar type of surfactant is also anaerobically biodegradable e g C12 18 Alkyl ether 1 3 EO sulphate DID No 2009 is anaerobically biodegradable and a similar anaerobic biodegradability may also be assumed for C12 15 A 6 EO sulphate Where anaerobic biodegradability has been confirmed for a surfactant by use of an appropriate test method it can be assumed that a similar type of surfactant is also anaerobically biodegradable e g literature data confirming the anaerobic biodegradability of surfactants belonging to the group alkyl ester ammonium salts may be used as documentation for a similar anaerobic biodegradability of other quaternary ammonium salts containing ester linkages in the alkyl chain s 2 Perform screening test for anaerobic deqradability If new testing is necessary perform a screening test by use of EN ISO 11734 ECETOC No 28 June 1988 OECD 311 or an equivalent method 3 Perform low dosage degradability test If new testing is necessary and in the case of experimental problems in the screening test e g inhibition due to toxicity of test substance repeat testing by using a low dosage of surfactant and monitor degradation by 14C measurements or chemical analyses Testing at low dosages may be per
26. ation of the mixture classification shall be provided according to the rules under Regulation EC No 1272 2008 together with information relevant to the mixtures hazard classification according to Annex II to Regulation EC No 1907 2006 For substances listed in Annexes IV and V to Regulation EC No 1907 2006 which are exempted from registration obligations under point a and b of Article 2 7 of that Regulation a declaration to this effect by the applicant shall suffice to comply with criterion 3 b A declaration on the presence of ingoing substances that fulfil the derogation conditions shall be provided by the applicant supported where appropriate by declarations from the producer s of the raw materials Where required for the derogation the applicant shall confirm the concentrations of these ingoing substances in the final product lt Declaration Hazardous substances and mixtures PartA ED 7 Declaration Hazardous substances and mixtures PartB ED Supplier Declaration Hazardous substances and mixtures ED Exemption Hazardous substances and mixtures ED F A Applicant Declaration Derogation Hazardous substances and mixtures Interpretation of criteria There are two parts to the declaration 1 A list of all the ingoing substances Part A 2 A declaration relating to the derogation list Part B to be provided if applicable 3 c Ingoi
27. be submitted to the Competent Body aa Completed spreadsheet for calculation of CDV value of the product Declaration Toxicity to aquatic organisms CDV Criterion 2 Biodegradability 2 a Biodegradability of surfactants 2 b Biodegradability of organic ingoing substances Documents to be submitted to the Competent Body Completed spreadsheet for calculation of biodegradability of surfactants amp organic substances Test results showing aerobic and anaerobic biodegradability where required Declaration Biodegradability Criterion 3 Excluded or limited substances and mixtures 3 a Specified excluded ingoing substances and mixtures Declaration Specified excluded ingoing substances and mixtures Documents to be submitted to the Competent Body x A Safety Data Sheets Supplier Declaration Specified excluded ingoing substances and mixtures Ld 3 b Hazardous substances and mixtures Documents to be submitted to the Competent Body apply B Supporting information as listed in criterion Pi Version 1 0 Page 74 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Safety Data Sheets Declaration Hazardous substances and mixtures PartA Declaration Hazardous substances and mixtures Part B Supplier Declaration Hazardous substances and mixtures Exemption Hazar
28. by the Competent Body a contract is issued which sets out the range of products covered including any trade names This contract sets out the terms of use of the EU Ecolabel following the standard contract in Annex IV of the Regulation EC no 66 20 10 of 25 November 2009 Once the contract is signed by the applicant a certificate can be requested This certificate will detail e the licence number that can be used with the EU Ecolabel logo e the legal name of the applicant e the range of products awarded the EU Ecolabel e all relevant trade names under which the product is sold Upon receipt of the signed contract the licence holder can use the EU Ecolabel logo and licence number on the relevant products in accordance with the EU Ecolabel Logo guidelines which can be found at V lec europa eu environment ecolabel documents logo_quidelines pdf Revision of criteria A The criteria for each product group are revised every three four years and existing EU Ecolabel holders have to re apply when these new revised criteria come into force Therefore it is advisable to consider the timing of your application to avoid consecutive application and then re application under new criteria A transition period for adjusting the product s formulation and applying for re assessment is usually allowed for and is set out in the new criteria document For more information about the application process visit the EU Ecolabel website at ht
29. dous substances and mixtures Declaration Derogation Hazardous substances and mixtures 3 c Ingoing substances listed in accordance with Article 59 1 of Regulation EC No 1907 2006 iveluded Does not Documents to be submitted to the Competent Body ean apply Supporting information as listed in criterion cui Safety Data Sheets Applicant Declaration Declaration 3 c Ingoing substances listed in accordance with Article 59 1 of Regulation EC No 1907 2006 Supplier Declaration Ingoing substances listed in accordance with Article 59 1 of Regulation EC No 1907 2006 3 d Fragrances Documents to be submitted to the Competent Body a na Declaration Fragrances Supplier Declaration Fragrances a a 3 e Preservatives Documents to be submitted to the Competent Body apply Safety Data Sheets of added preservatives including information on BCF and or log Kow values Declaration Preservatives 3 f Colorants Documents to be submitted to the Competent Body apply ES Safety Data Sheets of added colorants including information on BCF and or log Koy values or other required documentation Declaration Colorants Version 1 0 Page 75 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Criterion 4 Packaging 4 a Primary packaging Documents to be
30. e less than 0 28 gram of packaging per gram of product for each of the packaging in which the product is sold AN Pre shaving products packed in metal aerosol containers are exempted from this requirement Interpretation of criteria Pre shaving products are products used to protect the epidermis and lubricate the hair before shaving they can be in from of gel foam or cream PIR shall be calculated separately for each of the packaging as follows PIR W Wrefill x F N Nrefill x F D Drefill x F Where W weight of packaging primary proportion of secondary including labels 9 Wrefill weight of refill packaging primary proportion of secondary including labels g N weight of non renewable non recycled packaging primary proportion of secondary including labels g Nrefill weight of non renewable and non recycled refill packaging primary proportion of secondary including labels g 13 Proportional weight of the grouping packaging e g 50 of the total grouping packaging weight if two products are sold together EET Version 1 0 Page 27 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU D weight of product contained in the parent pack g Drefill weight of product delivered by the refill g F number of refills required to meet the total refillable quantity
31. ections Further information can be found at W http ec europa eu environment ecolabel documents eu ecolabel_fees pdf According to the Commission Regulation EU No 782 2013 of 14 August 2013 amending Annex IlI to the Regulation EC No 66 2010 of the European Parliament and of the Council on the EU Ecolabel 25 November 2009 Version 1 0 Page 7 of 77 ret N EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Ecolabe Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU www ecolabel eu 2 The application process The first step in starting the application process is to contact your Competent Body as they can help you in compiling your application See section above Who can apply to find out which Competent Body ies you should apply to The contact details of all the EU Ecolabel Competent Bodies are available at v http ec europa eu environment ecolabel competent bodies html Figure 1 outlines the stages involved in applying for the EU Ecolabel Further detail is given in the explanations that follow Figure 1 EU Ecolabel application stages Application stages Decision on eligibility If the EU Ecolabel is awarded a standard contract will be issued wW See Step 5 Award of licence W Assessment Application Information T and testing ECAT registration Contact your Competent Body CB Contacting your CB prior to Registration on ECAT Ensure requested Subm
32. ersion 1 0 Page 36 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU In case the product is made outside the European insert name of country where application is received Economic Area market European Union plus Iceland Lichtenstein and Norway please confirm the country where it has been or will be placed on the market Please state EU countries in which this product is sold in the same form if sold under different names please state names to be registered Information on the application Is this the first application for the EU Ecolabel for the product s specified above If no please state when and where the first application was made and with what outcome Is this an application to add a new product i e with a technical formulation not covered by an existing La Details Ecolabel that you hold to a licence fora product range already covered by an Ecolabel if so please give details of the existing Ecolabel Please indicate if an application for the same product has been successful under other environment label schemes e g the Nordic Ecolabel or Blue Angel Does the laboratory where the tests were conducted meet the general requirements expressed in standard EN ISO 17025 Application fees A An invoice will be sent when the app
33. formed by use of OECD 308 August 2000 or an equivalent method Version 1 0 Page 69 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Appendix Il test procedure for measuring the residual quantity 1 Definition of the indicator One function of the packing is to facilitate the use of the product The restitution rate shows the percentage of product actually consumable The coefficient of restitution shall be verified in accordance with the normal use of each product 1 If a pressure on a container is usually requested for the use of a product this same pressure must be applied to determine the coefficient of restitution The emptying is considered to be completed once no product comes out while respecting the usual conditions of use 2 For certain products when it s possible consideration should be given to a practice already used by many users At the end of use it is possible for the user by pulsing in a water supply to introduce a bit of water in the container to make less thick the content so as to finish the remaining product inside When this operation is feasible the coefficient of restitution should take into account a little bonus Residual amount R amount of product remaining in the container after the consumer has emptied the container The rate is expressed as a weight percentage and defined as follows R mass of
34. from the hair and or skin in comparison with the market leading product At least 80 of the consumers must be at least as satisfied with the product as with the market leading product 2 If a laboratory test is employed the producer s own test method can be accepted The applicant must however demonstrate that the test gives a measure of the product s performance Both consumer or laboratory tests shall fulfil the general requirements for all tests as described in Chapter Il and of the Guidelines for the Evaluation of the Efficacy of Cosmetic Products and test protocols and reports shall contain information indicated in Chapter Ill and Chapter IV of this document for respective testing methods 18 This guidance has been taken from Appendix of the EU Ecolabel for soaps shampoos and hair conditioners available here http ec europa eu environment ecolabel products qroups and criteria html E Version 1 0 Page 73 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU Part E Checklist Applicant s Checklist This checklist summarises the documentation to be provided for each criterion This checklist must be completed by the applicant Mark when done Documents to be submitted to the Competent Body apply B Part C Application form Criterion 1 Toxicity to aquatic organisms Critical Dilution Volume CDV Documents to
35. hnical dossier of laboratory test reports and send this in duplicate to the Competent Body and keep an up to date file on their premises showing continuing compliance with the criteria Equivalent test methods others than the ones indicated by the formal Commission Decision may be used provided the test methods have been approved by the awarding Competent Body Version 1 0 Page 35 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU Applicant information Applicant s full company name and address Contact person Position Phone Fax Email Website VAT number or equivalent if relevant If relevant existing licence number XX YYY In what capacity are you applying for the EU Manufacturer Ecolabel tick as appropriate Importer Service provider Wholesaler Retailer Product Information What product group are you applying for Shampoo shower preparations and liquid soaps Solid soaps Hair conditioners Shaving foams shaving gels shaving creams Shaving solid soaps Please give general specification of the product s including registered name s i e Trade name trademarks product type general description Name and address of manufacturing site s if different from above V
36. hree alternatives is fulfilled 1 Readily degradable and has low adsorption A lt 25 2 Readily degradable and has high desorption D gt 75 Version 1 0 Page 17 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU G Readily degradable and non bioaccumulating ME Testing for adsorption desorption may be conducted in accordance with OECD guidelines 106 ME Declaration Biodegradability Interpretation of criteria Surfactant means any organic substance and or mixture used in detergents which has surface active properties and which consists of one or more hydrophilic and one or more hydrophobic groups of such a nature and size that it is capable of reducing the surface tension of water and of forming spreading or adsorption monolayers at the water air interface and of forming emulsions and or microemulsions and or micelles and of adsorption at water solid interfaces Regulation EC No 648 2004 A spreadsheet is provided to complete this calculation http ec europa eu environment ecolabel documents Calculation 20Sheet 20cosmetics xlsx The total aNBO and anNBO can be determined by summing the concentration of each organic ingoing substance which is classified aNBO or anNBO aNBO 5 aNBO 1 aNBO 2 aNBO 3 and anNBO J anNBO 1 anNBO 2 anNBO 3 Where aNBO is the total co
37. ii the undersigned hereby declare that product refills are available for purchase on the market Please describe the type of refill system offered such as kinds of refills volume etc in the box below Please also attach evidence that refills are available for purchase such as a photograph of the refill etc Version 1 0 Page 58 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU Declaration 4 c Design of primary packaging Applicant For the following product formulation cecescusssssussesessssesssessssssssessssscscssscssssssesesussssssssesissesessssscscssatsmeseasecssssesessacseees the undersigned hereby declare that the residual amount of product left in the packaging R has been calculated using the following equation please complete the table below to show this R m2 ms mi ms x 100 Where mi Primary packaging and product g m2 Primary packaging and product residue in normal conditions of use g ms Primary packaging emptied and cleaned g and amounts Package size Please provide a description of the dosage device below A test report with results of measuring the residual quantity of a rinse off cosmetic product in the packaging according Appendix Il of this user manual is enclosed to the application Version 1 0 Page 59 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUA
38. ilable they can either be estimated or calculated using testing procedures described in Appendix I Version 1 0 Page 15 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Required documentation for Assessment and verification Toxicity to aquatic organisms Critical Dilution Volume CDV ini The applicant shall provide the calculation of the CDV of the product A spreadsheet for calculation of the CDV value is available on the EU Ecolabel website ini The values of DF and TF chronic shall be as given in the DID list part A If the ingoing substance is not included in the DID list part A the applicant shall determine the values using the guidelines described in the DID list part B and attaching the associated documentation for more information see Appendix B Declaration Toxicity to aquatic organisms CDV Interpretation of criteria The spreadsheet for calculation of the CDV of the product can be found here http ec europa eu environment ecolabel documents Calculation 20Sheet 20cosmetics xlsx A calculation of all recipes formulation shall be made A recipe can cover several products trade names If a recipe covers more than one trade name this shall be clearly indicated Version 1 0 Page 16 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel f
39. inimise the production of waste and e Support high quality and high performance products which are fit for use The criteria are valid until 9 December 2018 This User Manualis for guidance only it does not have any legal standing and does not in any way replace the Commission Decision or any relevant legislation In case of doubt on specific points in the Manual please refer directly to the national Competent Body Version 1 0 Page 5 of 77 uNa EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Ecolabel Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU 1 3 Who can apply for the EU Ecolabel Manufacturers importers and service providers may submit applications for the award of the EU Ecolabel Traders and retailers may also apply but may only submit applications for products marketed under their own brand names 1 4 Where do apply EU Ecolabel applications are made via a single application that covers all of the European Economic Area EEA Each EEA member state has nominated a Competent Body which assesses applications for the award of the EU Ecolabel The choice of which competent body you should apply to is determined by the following rules e If the product originates in one of the EEA Member States then an application should be made to the EU Ecolabel Competent Body of that Member State e If your product originates from outside the EEA you should apply to the EU Ecolabel Competent B
40. iodegradable phosphonates viii The following preservatives triclosan parabens formaldehyde and formaldehyde releasers ix The following fragrances and ingredients of fragrance mixtures Hydroxyisohexyl 3 cyclohexene carboxaldehyde HICC Atranol and Chloroatranol x Micro plastics xi Nanosilver Signature of person bearing legal responsibility Company Stamp Version 1 0 Page 44 of 77 E NE EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Ecolabel Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Declaration Criteria 3 b Hazardous substances and mixtures Part A Product formulation Applicant For the following product formulation uss cecsssssssussesssssesssssssssecscssssssescscssssssessesssenesssssssecsnsssessscsesusssassesssesetenesess the undersigned hereby confirm that the Excel document attached to the application http ec europa eu environment ecolabel documents Calculation 20Sheet 20cosmetics xlsx provides a full formulation of the product indicating trade name chemical name CAS no and INCI designations risk or hazard phrases DID no the ingoing quantity including and excluding water the function and the form of all ingredients greater than 0 010 Safety data sheets for each ingoing substance or mixture in accordance with Regulation EC No 1907 2006 of the European Parliament and of the Council shall be provided to the competent body
41. it all documents required The CB may carry out a application can help solveany Ecolabel catalogue is documentation is compiled for application including the site visit to the applicant potential issues that may required for registering in a dossier and any tests application form and application or its suppliers decided hinder the application process your application carried out in the correct dossiers the number of copies on case by case basis or prevent the licence from See Step l ECAT format and format of these may vary by See Step 4 Assessment being awarded registration See Step 2 Information Member State See Part A section 2 The testing and verification See Step 3 Compile and application process submit dossier and application form Version 1 0 Page 8 of 77 uNa EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Ecolabel Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU www ecolabel eu Step 1 ECAT registration The online tool ECAT the EU Ecolabel E Catalogue must be used to initially register your application for an EU Ecolabel licence V Follow the instructions on the E Catalogue User Manual which you can download from http ec europa eu environment ecolabel ecolabelled_products pdf user_manual Ecat_admin 20user 20man ual 20for 20Applicants pdf This user manual outlines the process for registration which will include registering under the European Commission Authentication
42. laration 3 d Fragrances Supplier duplicate for each As the supplier of the following fragrance s fora rinse off cosmetic product s the undersigned hereby declare that the recommendations of the IFRA Standards concerning prohibition restricted use and specified purity criteria for materials are followed during manufacture I Version 1 0 Page 53 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Declaration 3 e Preservatives Applicant For the following product formulation cececcusssssussesessssesssessssssssesssscscssscssssssesesmesssssesssissesesssssscssstsmssescscasesessnseesees the undersigned hereby declare that i The following preservatives are used in the rinse off cosmetic product s and ii These preservatives do not release or degrade to substances that are classified in accordance with the requirements of criterion 3 b and iii The preservatives used in the product are not bioaccumulating Note A preservative is considered not bioaccumulating if BCF lt 100 orlogKoy lt 3 0 If both BCF and logK w values are available the highest measured BCF value shall be used Signature of person bearing legal responsibility Position held Company Stamp Version 1 0 Page 54 of 77 os NE EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Ecolabel Commission Decision of for the award of the EU
43. le phosphonates viii The following preservatives triclosan parabens formaldehyde and formaldehyde releasers ix The following fragrances and ingredients of fragrance mixtures Hydroxyisohexyl 3 cyclohexene carboxaldehyde HICC Atranol and Chloroatranol x Micro plastics xi Nanosilver Required documentation for Assessment and verification Specified excluded ingoing substances and mixtures B The applicant shall provide a signed declaration of compliance supported by declarations from manufacturers of mixtures as appropriate confirming that the listed substances and or mixtures have not been included in the product above defined concentrations ME Declaration Specified excluded ingoing substances and mixtures ma Supplier Declaration Specified excluded ingoing substances and mixtures 3 b Hazardous substances and mixtures According to Article 6 6 of Regulation EC No 66 2010 the EU Ecolabel may not be awarded to any product that contains substances meeting criteria for classification with the hazard statements or risk phrases 8 Also called micro beads Version 1 0 Page 19 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU specified in Table 3 in accordance with Regulation EC No 1272 2008 of the European Parliament and of the Council or Council Directive 67 548 EC or substances referred
44. least equivalent to those of the RSPO and have been developed by a multi stakeholder organisation who have a broad based membership including NGOs industry and government Please attach the necessary supporting documentation and evidence including third party certification of amounts purchased produced and claimed for the most recent annual trading period Tr c r r r TETE ETii iccillo o Version 1 0 Page 63 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU Declaration Criterion 5 Sustainable sourcing of palm oil palm kernel oil and their derivatives Applicant Section 3 Palm Oil and or Palm Kernel Oil Derivatives I the undersigned declare that please delete those of the three following statements which do NOT apply 1 We are a member of the RSPO Roundtable on Sustainable Palm oil __ _______ please insert membership number and the total quantity of derivatives claimed as certified or supporting the production of sustainable palm oil both product s to be EU Ecolabelled and products making other sustainable palm oil claims such as RSPO trademark produced during the most recent annual trading period is within the ACOP declared certificated amounts of redeemed GreenPalm Mass balance MB Identity Preserved IP Segregated SEG The link s to the appropriate certificates and or the ACOP
45. led in calculation spreadsheet and the application dossier the number of copies and format of these may vary by Member State to the relevant Member State Competent Body For further information please contact your Competent Body Step 4 Assessment After receiving an application the Competent Body examines the documentation including any material sent directly by suppliers The Competent Body can ask for further information if necessary within two months of receipt of an application The Competent Body may make a list of any additional documentation required in order to comply with the EU Ecolabel product group criteria This list will be forwarded to the applicant who must ensure that the relevant documentation is provided It should also be noted that a Competent Body can reject an application if all the relevant documentation is not received within 6 months of the initial application Version 1 0 Page 9 of 77 ie uNa EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Ecolabel Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU www ecolabel eu After all the documentation has been approved the Competent Body may carry out an on site visit to the applicant and or its suppliers The Competent Body makes this judgement on a case by case basis and may charge for it Again please contact your Competent Body for details Step 5 Award of licence When the application has been assessed and is approved
46. lication and the attached declarations are received Before the application can be processed the applicant must pay the application fee relevant for the company Please refer to your Competent Body for fees Version 1 0 Page 37 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU This declaration is to be used so that the Competent Body can set the appropriate application and eventually annual licence fees for the EU Ecolabel cf Regulation EC No 66 2010 of The European Parliament and of The Council of 25 November 2009 on the EU Ecolabel appendix III All questions below have to be answered before handling of the application can begin Declaration Type of Company Is the company a micro sized company as defined in the Commission s Recommendation 2003 36 1 EC i e under 10 employees and an annual turnover or total annual balance not exceeding 2 mill Euro Is the company a small or medium sized company as defined in the Commission s Recommendation 2003 36 1 EC i e under 250 employees and an annual turnover not exceeding 50 mill Euro or total annual balance not exceeding 43 mill Euro Is the company situated in a developing country as defined in the OECD s Development Assistance Committee s list of countries receiving development aid Is the company registered under EMAS and or ce
47. ls volume For approval of refill packaging the applicant or retailer shall document that the refills shall be available for purchase on the market Declaration Packaging Impact Ratio B Declaration Packaging Impact Ratio to be completed only where refills are available Version 1 0 Page 28 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Interpretation of criteria For products for which refills are available the applicant needs to provide evidence that they produce and sell refills This evidence may be for example product packaging or marketing materials v The spreadsheet for the calculation of PIR can be found here http ec europa eu environment ecolabel documents Calculation 20Sheet 20cosmeticsxlsx 4 c Design of primary packaging The primary packaging shall be designed to make correct dosage easy e g by ensuring that the opening at the top is not too wide and to ensure that at least 90 of the product can be removed easily from the container The residual amount of the product in the container R which must be below 10 shall be calculated as follows R m2 m3 m1 m3 x 100 Where mi Primary packaging and product g m2 Primary packaging and product residue in normal conditions of use g m3 Primary packaging emptied and cleaned g Interpretation
48. mpleting these declarations An example declaration is shown below Declaration 3 d Fragrances Declaration including Applicant sections to be completed by As the manufacturer importer retailer of rinse off cosmetics that comply with the EU Ecolabel the the applicant and or undersigned hereby declare that supplier s i Products marketed as designed and intended for children do not contain fragrances i Ingoing substance or mixture added to the product as a fragrance are manufactured and handled following the code of practice of the International Fragrance Association IFRA Information to be completed by the person Signature of person bearing legal responsible for this responsibility deciaration Position held Company Stamp A Please read this manual all the way through before completing and submitting the application form or any other documentation Version 1 0 Page 4 of 77 eV EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Ecolabel Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU www ecolabel eu Part A General Information 1 Introduction This User Manual is for guidance only and is designed to help you apply for the EU Ecolabel for rinse off cosmetic products It includes an outline of all data tests and documentation that are required to demonstrate compliance The basis for the manual is the Commission Decision of 9 December 2014 establishing the ecologic
49. n accordance with Regulation EC No 1907 2006 of the European Parliament and of the Council Interpretation of criteria The information requested above is also requested as part of criterion 3 b The information does not need to be sent more than once Safety data sheets provide comprehensive information about a substance or mixture for use in workplace chemical control regulatory frameworks Both employers and workers use it as a source of information about hazards including environmental hazards and to obtain advice on safety precautions CAS numbers are unique numerical identifiers assigned by the Chemical Abstracts Service to every chemical substance described in the open scientific literature INCI International Nomenclature of Cosmetic Ingredients are standardised scientific names for all cosmetic ingredients These allow ready identification of ingredients rather than the used of trade or common names Measure ment thresholds for compliance verification are given for each criterion in below table no no no no reservatives x n Re 20 010 20 010 x ee xX no no no no colorants ua X Cnr sir 20 010 20 010 x x oy X limit limit limit limit no no no no no limit means regardless of the concentration all substances intentionally added by products and impurities from raw materials analytical limit of detection 2 DID no is thenumberofthe ingoing substance onthe DID list G OJ L 396 30 12 2006 p 1 4 Euro
50. n may not need to be sent to the Competent Body unless there is a specific requirement to do so which will be set out in the relevant criterion but must be available at any time if requested If at any time during the validity period of the licence the product falls out of compliance with the criteria this must be reported to the Competent Body immediately together with a statement of the reasons for non compliance The Competent Body will decide the consequences of the non compliance e g a demand for additional measurements suspension of the licence etc 1 8 Assessment of compliance with the criteria The Competent Body may undertake any necessary investigations to monitor the licence holder s ongoing compliance with the EU Ecolabel Criteria and the terms of use and provisions of the contract To this end the Competent Body may request and the licence holder shall provide any relevant documentation to prove such compliance 1 9 Costs The applicant is responsible for compiling the application and obtaining all the necessary supporting evidence which may include tests etc In addition the applicant must pay an application fee and an annual licence fee where this is asked for by the Competent Body In some cases applicants may be charged for an on site verification which may include travel and accommodation costs Subsequent to the award of the licence Competent Bodies may also charge for extension modification fees and on site insp
51. ncentration of aNBO in mg g AC anNBO is the total concentration of anNBO in mg g AC aNBO x is the concentration of ingoing substance x which is classified as aNBO in mg g AC anNBO x is the concentration of ingoing substance x which is classified as anNBO in mg g AC Low adsorption means that the substance will not enter into or attach to the surface of solid material whereas high desorption means that a substance will readily remove itself from the surface of a solid material and enter into water Rubbing abrasive agents are not included in the calculation of the active content and should not be considered in the aNBO and anNBO calculation Version 1 0 Page 18 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Criterion 3 Excluded or limited substances and mixtures 3 a Specified excluded ingoing substances and mixtures The following ingoing substances and mixtures shall not be included in the product neither as part of the formulation nor as part of any mixture included in the formulation i Alkyl phenol ethoxylates APEOs and other alkyl phenol derivatives ii Nitrilo tri acetate NTA iii Boric acid borates and perborates iv Nitromusks and polycyclic musks v Octamethylcyclotetrasiloxane D4 vi Butylated Hydroxi Toluene BHT vii Ethylenediaminetetraacetate EDTA and its salts and non readily biodegradab
52. nel oil YES NO please delete as appropriate b The product contains derivatives of palm oil and or palm kernel oil YES NO please delete as appropriate If you indicated YES to a please go to Section 2 If YES to b please go to Section 3 Version 1 0 Page 62 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU Declaration Criterion 5 Sustainable sourcing of palm oil palm kernel oil and their derivatives Applicant Section 2 Palm Oil and or Pam Kernel Oil the undersigned declare that please delete the statement below which does NOT apply I We are a member of the RSPO Roundtable on Sustainable Palm oil __ please insert membership number and the total quantity of product claimed as certified both product s to be EU Ecolabelled and products making other sustainable palm oil claims such as RSPO trademark produced during the most recent annual trading period is within the ACOP declared and or certificated amounts of Mass balance MB Identity Preserved IP Segregated SEG The link s to the appropriate certificates and or the ACOP on the RSPO website are _______ 2 i _________ please insert the website links OR 2 We can demonstrate that the palm oil and or palm kernel oil has been sourced from plantations that meet criteria for sustainable management i e that adhere to a set of principles and criteria that are at
53. new technical characteristics which affect compliance with the criteria for example new materials These must be approved by the Competent Body before use A request for extension must be sent to the Competent Body together with all the necessary supporting documentation as Version 1 0 Page 6 of 77 uNa EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Ecolabel Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU www ecolabel eu required in the Assessment and verification section s of the relevant affected criterion criteria e Addition or substitution of new suppliers The Competent Body should be provided with appropriate documentation proving the suppliers compliance with the criteria In addition an updated list of suppliers must be provided e All other changes should be notified to the Competent Body in any case so that they can determine whether or not they may affect ongoing compliance 1 7 Continuous control the responsibility of the applicant The applicant is responsible for ensuring that the product s once awarded the EU Ecolabel always remains in compliance with the EU Ecolabel Criteria After an EU Ecolabel licence has been granted the licence holder must keep the application dossier up to date In cases where continued tests or measurements are required the licence holder is responsible for keeping a record of the test results and other relevant documentation This documentatio
54. ng substances listed in accordance with Article 59 1 of Regulation EC No 1907 2006 No derogation from the exclusion in Article 6 6 of Regulation EC No 66 2010 shall be given concerning ingoing substances identified as substances of very high concern and included in the list provided in Article 59 1 of Regulation EC No 1907 2006 present in the product in concentrations higher than 0 010 weight by weight ul Available at http echa europa eu chem_data authorisation_process candidate list table_en asp SSS o_o e ao o e ye _ye_ _ee _e_ e__e_ mm c i Version 1 0 Page 23 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU Interpretation of criteria Substances of Very High Concern are substances that may have serious and often irreversible effects on human health and the environment Where identified they are included in a list of substances that are under tight control for which special permission must be sought before their use The European Chemicals Agency ECHA maintain a list of these substances which is available at http www echa europa eu addressing chemicals of concern restrictions list of restrictions list of restrictions table Required documentation for Assessment and verification Ingoing substances listed in accordance with Article 59 1 of Regulation EC No 1907 2006 B The applicant shall pro
55. ody of the EEA Member State in which the product is or is about to be placed on sale All EEA Member States assess applications against the same criteria but individual States have slightly different procedures and fee levels for handling applications For contact details for each Member State s Competent Body please visit v http ec europa eu environment ecolabel competent bodies html 1 5 What does an application contract cover An application for an EU Ecolabel covers a product or product range regardless of how many different names or brands are used for that product Therefore the applicant must report all the trade names or reference numbers of the product s in question during the process of application The formulation including all chemical substances and mixtures used in the product must be submitted as part of the application 1 6 How do I extend or make changes to my EU Ecolabel licence Once the EU Ecolabel has been awarded if the licence holder wants to extend the range of products covered by the licence or make any other changes the following conditions apply e Extension with new commercial identification reference names which do not affect compliance with the criteria In this case the relevant information should be sent to the Competent Body After scrutiny and if accepted the Competent Body will issue a revised licence with the new additional commercial references trade names added e Extension with
56. of criteria Examples of ensuring that the correct dosage is being delivered could also include a correct size pump dispenser Required documentation for Assessment and verification Design of primary packaging B The applicant shall submit a description of the dosage device and test report with results of measuring the residual quantity of a rinse off cosmetic product in the packaging The test can be done externally or internally The test procedure for measuring the residual quantity is described in Appendix Il of this Manual B Declaration Design of primary packaging Interpretation of criteria This calculation should be performed separately for each size packaging Version 1 0 Page 29 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU www ecolabel euw 4 d Design for recycling of plastic packaging Plastic packaging shall be designed to facilitate effective recycling by avoiding potential contaminants and incompatible materials that are known to impede separation or reprocessing or to reduce the quality of recyclate The label or sleeve closure and where applicable barrier coatings shall not comprise the materials or components listed in Table 5 Table 5 Materials and components excluded from packaging elements Packaging Excluded materials and components element PS label or sleeve in combination with
57. on the RSPO website are please insert the web site link s 2 We are a member of GreenPalm ______ please insert membership number and the total quantity of product claimed as supporting the production of sustainable palm oil both product s to be EU Ecolabelled and other products produced during the most recent annual trading period is equal to the amount of GreenPalm certificates purchased during the same trading period attach a copy of the annual return to GreenPalm or if this is not yet available within three months of the end of the next annual trading period 3 We can demonstrate that the palm oil derivatives and or palm kernel oil derivatives have been sourced from plantations that meet criteria for sustainable management i e that adhere to a set of principles and criteria that are at least equivalent to those of the RSPO and have been developed by a multi stakeholder organisation who have a broad based membership including NGOs industry and government Please attach the necessary supporting documentation and evidence including third party certification of amounts purchased produced and claimed for the most recent annual trading period Version 1 0 Page 64 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU Declaration Criterion 5 Sustainable sourcing of palm oil palm kernel oil and their derivatives Supplier duplicate
58. or rinse off cosmetics 2014 893 EU Criterion 2 Biodegradability 2 a Biodegradability of surfactants All surfactants shall be readily biodegradable under aerobic conditions and biodegradable under anaerobic conditions 2 b Biodegradability of organic ingoing substances The content of all organic ingoing substances in the product that are aerobically non biodegradable not readily biodegradable aNBO and anaerobically non biodegradable anNBO shall not exceed the limits in Table 2 Table 2 aNBO and anNBO limits Product aNBO mg g AC anNBO mg g AC Required documentation for Assessmentand verification Biodegradability B The applicant shall provide documentation for the degradability of surfactants as well as the calculation of aNBO and anNBO for the product A spreadsheet for calculation of aNBO and anNBO values is available on the EU Ecolabel website For both surfactants and aNBO and anNBO values reference shall be made to the DID list For ingoing substances which are not included in the DID list the relevant information from literature or other sources or appropriate test results showing that they are aerobically and anaerobically biodegradable shall be provided as described in Appendix I In the absence of documentation in accordance with the above requirements an ingoing substance other than a surfactant may be exempted from the requirement for anaerobic degradability if one of the following t
59. ormation appearing ON the EU Ecolabel 34 P rt Application FOT lilla 35 PartD Declarations Lrccada alati 40 Appendix DID list Appendix Il test procedure for Measuring the residual QUANTITY Lie 70 Appendix Ill Palm Derivatives csssssssssssssssatinstsetstenstetestntenistsnesistenistsnustienesintetistintesintesinstieintieinnese 72 Appendix IV Guidelines for fitness for USE testing 73 Parte Checklist 74 Version 1 0 Page 2 of 77 le eu NE Ecolabe www ecolabel eu EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Using this manual This manual guides you through the process of applying for an EU Ecolabel in accordance with the criteria requirements The following symbols are used throughout Notable or important information Clarification of a key point Required documentation to verify compliance with criteria including links to declarations where needed The manual is structured as follows Part A General Information Provides information about the EU Ecolabel including a summary of the criteria details of the application process and answers to frequently asked questions about applying Part B Product Assessment and Verification Outlines the criteria for rinse off cosmetics set out in the Commission Decision 2014 312 EU An example from this section is shown below Prod
60. ous substances and mixtures Part B Supplier the undersigned as a supplier of the following ingoing substances raw materials hereby declare that have provided all the necessary information which is needed by the applicant to prove the compliance with the requirements of the criterion 3 b NOTE The following technical information related to the form s and physical state s of the ingoing substances and or mixtures as present inthe product shall be provided to support the declaration of non clas sification i For substances that have not been registered under the REACH Regulation or which do not yet have a harmonised CLP classification Information meeting the requirements listed in Annex VII to the REACH Regulation ii For substances that have been registered under the REACH Regulation and which do not meet the requirements for CLP classification Information based on the REACH registration dossier confirming the non classified status of the substance iii For substances that have a harmonized classification or are self classified safety data sheets where available If these are not available or the substance is self classified then information shall be provided relevant to the substances hazard classification according to Annex Il to the REACH Regulation iv In the case of mixtures Safety data sheets where available If these are not available then calculation of the mixture classification shall be provided according to the r
61. pean Chemical Agency Guidance on the compilation of safety data sheets February 2014 Version 1 0 Page 14 of 77 ie uve EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Ecolabel Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Criterion 1 Toxicity to aquatic organisms Critical Dilution Volume CDV The total CDV toxicity of the product shall not exceed the limits in Table 1 Table 1 CDV limits Product CDV I g AC The CDV is calculated using the following equation CDV Y CDV ingoing substance i gt weight i x DF i x 1000 TFchronic i Where weight i is the weight of the ingoing substance in grams per 1 gram of AC i e normalised weight contribution of the ingoing substance to the AC DF i is the degradation factor of the ingoing substance TF chronic i is the toxicity factor of the ingoing substance in milligrams litre Interpretation of criteria CDV expresses the amount of water needed for the hypothetical dilution of a product at which the product can be considered to have no environmental impact The unit is expressed in litres per functional unit DF degradation factor is based on how readily biodegradable the substance is It is calculated based on test results on the substance using methods described in Annex 1 and using the DID list Part B table 1 DF and TF Chronic are usually within the DID list part A Where they are not ava
62. r to applying a new pressure Repeat until no amount of product flows from the spray after five successive pressures Neither the cap is dismantled nor water is introduced inside the packaging X Pot The product is removed using the index and middle fingers by rubbing the edges and the bottom of the pot carefully but relentlessly Neither the cap is dismantled nor water is introduced inside the packaging K Vial flask Returns the vial upside down with the cap in downward position After the trickle is not continuous the bottle is left in the same position for another two minutes Neither the cap is dismantled nor water is introduced inside the packaging The packaging must be designed to make correct dosage easy e g by ensuring that the opening at the top is not too wide and to ensure that at least a 90 of the product can be removed easily from the container The residual amount of the product in the container R which must be below 10 shall be calculated as follows R m2 m3 m1 m3 x 100 Where m1 Primary packaging and product g m2 Primary packaging and product residue in normal conditions of use g m3 Primary packaging emptied and cleaned g Version 1 0 Page 71 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU GLY CERINE SURLAGTANTE GLYCEROL ESTERS Fabric Conditioners GMO GMS etc
63. rds could include ISO7827 Version 1 0 Page 68 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU The 10 days window principle shall not apply for surfactants The pass levels shall be 70 for the tests referred to in Annex V C4 A and C4 B to Directive 67 548 EEC and their equivalent OECD 301 A and E tests and ISO equivalents and shall be 60 for tests C4 C D E and F and their equivalent OECD 301 B C D and F tests and ISO equivalents or The test methods provided for in Regulation EC No 1272 2008 2 After 1 December 2015 The test methods provided for in Regulation EC No 1272 2008 Documentation of anaerobic biodegradability The reference test for anaerobic degradability shall be EN ISO 11734 ECETOC No 28 June 1988 OECD 311 or an equivalent test method with the requirement of 60 ultimate degradability under anaerobic conditions Test methods simulating the conditions in a relevant anaerobic environment may also be used to document that 60 ultimate degradability has been attained under anaerobic conditions Extrapolation for substances not listed in the DID list Where the ingoing substances are not listed in the DID list the following approach may be used to provide the necessary documentation of anaerobic biodegradability 1 Apply reasonable extrapolation Use test results obtained with one raw material to extrapol
64. res and or closure material with density of above 1 g cm3 in combination with a PET bottle Closures made of metal glass EVA Closures made of silicone Exempted are silicone closures witha density lt 1 g cm3 in combination witha PET bottle and silicone closures withadensity gt 1g cm3 in combination with PP or HDPE bottle Metallic foils or seals which remain fixed to the bottle orits closure after the product has beenopened Version 1 0 Page 60 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Material and additional details Note the following must not be part of barrier coating elements Polyamide EVOH functional polyolefins metallised and light blocking barriers al Se Adhesives Barrier coating DBT ae eee Version 1 0 Page 61 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU Declaration Criterion 5 Sustainable sourcing of palm oil palm kernel oil and their derivatives Applicant All applicants must complete Section 1 and if required Sections 2 and or 3 Section 1 For the following product formulation u ceccusssesusssevssessscessssescsssscsesmesssssesesesssessssssssesssmssesssessssessssssssssceesscecsescecaees I the undersigned declare that a The product contains palm oil and or palm ker
65. rfactants in total H412 Harmful to aquatic life with concentrations lt long lasting effects 20 in the final product Total concentration H412 Harmful to aquatic life with long lasting effects Fragrances H413 May cause long term adverse effects to aquatic life Zinc pyrithione ZPT H400 Very toxic to aquatic life used in anti dandruff shampoos Signature of person bearing legal responsibility Position held Company Stamp Preservatives H411 Toxic to aquatic life with long R51 53 R52 53 lasti ffect asting effects R53 H412 Harmful to aquatic life with long lasting effects H413 May cause long term adverse effects to aquatic life Version 1 0 Page 49 of 77 ie uve EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Ecolabel Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Declaration 3 c Ingoing substances listed in accordance with Article 59 1 of Regulation EC No 1907 2006 Applicant For the following product formulation iii the undersigned hereby declare that ingoing substances identifiedas substances of very high concern and included in the list provided for in Article 5X1 of Regulation EC No 1907 2006 are not present in the final product I declare that have collected all necessary information from my suppliers to prove compliance with this criterion Position held Company Stamp Version 1 0
66. rtified under ISO 14001 and has the company in its environmental policy committed to maintain compliance of its EU Ecolabel products with the EU Ecolabel product group criteria throughout the contract s period of validity Date Company Name Company Stamp Responsible person s signature Print in capitals the name of above signatory 16 If confirmed the company must send a copy of the annual affirmative environmental statement EMAS or valid ISO 14001 certificate and copy of the companies environmental policy and objectives ISO 14001 in connection with the application and information on the annual turnover Version 1 0 Page 38 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Applicant s undertaking As the applicant for an EU Ecolabel hereby declare that understand and accept the provisions of Regulation EC No 66 2010 on the EU Ecolabel scheme and in particular Article 6 paragraph 6 which states that the EU Ecolabel may not be awarded to goods containing substances or preparations mixtures meeting the criteria for classification as toxic hazardous to the environment carcinogenic mutagenic or toxic for reproduction CMR in accordance with Regulation EC No 1272 2008 of the European Parliament and of the Council of 16 December 2008 on classification labelling and packaging of substances and mi
67. s Colorants in the product must not be bioaccumulating A colorant is considered not bioaccumulating if BCF lt 100 or log Kow lt 3 0 If both BCF and log Koy values are available the highest measured BCF value shall be used A In the case of colouring agents approved for use in food it is not necessary to submit documentation of bioaccumulation potential Required documentation for Assessment and verification Colorants The applicant shall provide copies of the safety data sheets of any colorant added together with information on its BCF and or log Kow value or documentation to ensure that the colouring agent is approved for use in food Declaration Colorants Version 1 0 Page 26 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Criterion 4 Packaging 4 a Primary packaging Primary packaging shall be in direct contact with the contents No additional packaging for the product as itis sold e g carton over a bottle is allowed with the exception of secondary packaging which groups two or more products together e g the product and refill Required documentation for Assessment and verification Primary packaging ini The applicant shall provide a signed declaration of compliance ini Declaration Primary packaging 4 b Packaging Impact Ratio PIR The Packaging Impact Ratio PIR must b
68. s and mixtures Derogation Hazardous substances and mixtures Criterion 3 c Ingoing substances listed in accordance with Article 59 1 of Regulation EC No 1907 2006 Ingoing substances listed in accordance with Article 59 1 of Requlation EC No 1907 2006 supplier declaration Criterion 3 d Fragrances Fragrances supplier declaration Criterion 3 e Preservatives Criterion 3 f Colorants Criterion 4 a Primary packaging Criterion 4 b Packaging Impact Ratio Packaging Impact Ratio to be completed only where refills are available Criterion 4 c Design of primary packaging Criterion 4 d Design for recycling of plastic packaging Criterion 5 Sustainable sourcing of palm oil palm kernel oil and their derivatives Criterion 6 Fitness for use Criterion 7 Information appearing on the EU Ecolabel Version 1 0 Page 40 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU Declaration Criteria 1 Toxicity to aquatic organisms Critical Dilution Volume CDV Applicant The spreadsheet for calculating the CDV of the product can be found at http ec europa eu environment ecolabel documents Calculation 20Sheet 20cosmetics xlsx For the following product formulation ceccusssssussssssssssscscsssescssssssesmesssesesesiessssssusseacscsesmssssssssssssssssnssssescsesssissesesesees the undersigned hereby declare that the CDV of
69. s not considered bioaccumulating if BCF lt 100 or log Kow lt 3 0 If both BCF and logKow values are available the highest measured BCF value shall be used Interpretation of criteria Bioaccumulation of substances within aquatic organisms can give rise to toxic effects over longer time scales even when actual water concentrations are low For organic substances the potential for bioaccumulation shall normally be determined by using the octanol water partition coefficient usually reported as a log K ow The relationship between the log Kw of an organic substance and its bioconcentration is measured by the bioconcentration factor BCF 2 la Regulation EC No 1272 2008 of the European Parliament and of the Coundil of 16 December 2008 on classification labelling and packaging of substances and mixtures amending and repealing Directives 67 548 EEC and 1999 45 EC and amending Regulation EC No 1907 2006 OJ L 353 31 12 2008 p 1 Version 1 0 Page 25 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Required documentation for Assessment and verification Preservatives ini The applicant shall provide a signed declaration of compliance together with copies of the safety data sheets of any preservative added and information on its BCF and or log Kow values ini Declaration Preservatives 3 f Colorant
70. s salts and non readily biodegradable phosphonates viii Preservatives triclosan parabens formaldehyde and formaldehyde releasers ix Fragrances and ingredients of fragrance mixtures Hydroxyisohexyl 3 cyclohexene carboxaldehyde HICC Atranol and Chloroatranol x Micro plastics xi Nanosilver Signature of person bearing legal responsibility ga NS Company Stamp Version 1 0 Page 43 of 77 ie uve EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Ecolabel Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Declaration Criteria 3 a Specified excluded ingoing substances and mixtures Supplier duplicate for each supplier As the supplier of the following components for the following Product formulation cescucssucscsesmesssssessesesssesessssssssssscscsescscsssssssesesssessssseesssessaescsessssesesssssssneeeness the undersigned hereby declare that the following ingoing substances and mixtures have not been included in the supplied components neither as part of the formulation nor as part of any mixture included in the formulation i Alkyl phenol ethoxylates APEOs and other alkyl phenol derivatives ii Nitrilo tri acetate NTA iii Boric acid borates and perborates iv Nitromusks and polycyclic musks v Octamethylcyclotetrasiloxane D4 vi Butylated Hydroxi Toluene BHT vii Ethylenediaminetetraacetate EDTA and its salts and non readily b
71. sion of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Declaration 4 b Packaging Impact Ratio PIR Applicant The calculation spreadsheet for PIR can be found at http ec europa eu environment ecolabel documents Calculation 20Sheet 20cosmetics xlsx For the following product formulation iii the undersigned hereby declare that a the content of post consumer recycled material or material from renewable origin in the packaging is Yow w b the value of PIR is less than 0 28 gram of packaging per gram of product for each of the packaging in which the product is sold Please complete the table below with actual PIR values Product and packaging please list each product and each type of packaging in Calculated PIR values which the product is sold l also confirm that this value has been calculated using the relevant PIR calculation spreadsheet please attach this to the application Note If the productis sold in different packaging i e with different volumes the calculation shall be submitted foreach packaging size Company Stamp Version 1 0 Page 57 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU Declaration 4 b Design of primary packaging Applicant to be completed only where refills are available For the following product formulation i
72. st is a generic source of information and substances present on the DID list are not automatically approved for use in EU Ecolabel products Part A and Part B of the DID list can be found on the EU Ecolabel website at http ec europa eu environment ecolabel documents did_list didlist part a_enpdf http ec europa eu environment ecolabel documents did list didlist part b_en pdf For substances with no data regarding aquatic toxicity and degradability structure analogies with similar substances may be used to assess the TF and DF Such structure analogies shall be approved by the competent body granting the EU Ecolabel license Alternatively a worst case approach shall be applied using the parameters below Worst case approach Acute toxicity Chronic toxicity Degradation Ingoing LC50 EC50 SFiaute TFracutey NOEC SF chronic TF chronic DF Aerobic Anaerobic substance If no acceptable chronic toxicity data are found these columns are empty In this case TF chronic defined as equal to TF acute Documentation of ready biodegradability The following test methods for ready biodegradability shall be used 1 Until 1 December 2015 The test methods for ready biodegradability provided for in Directive 67 S48 EEC in particular the methods detailed in Annex V C4 to that Directive or their equivalent OECD 301 A F test methods or their equivalent ISO tests Interpretation of criteria Equivalent ISO standa
73. submitted to the Competent Body Included pees has apply B Declaration Primary packaging 4 b Packaging Impact Ratio PIR Does not Documents to be submitted to the Competent Body Included apply Completed spreadsheet for calculation showing PIR calculation Declaration Packaging Impact Ratio Declaration Packaging Impact Ratio to be completed only where refills are available 4 c Design of primary packaging Documents to be submitted to the Competent Body Included Does not apply Description of the dosage device and test reports measuring residual quantity of product in packaging Declaration Design of primary packaging 4 d Design for recycling of plastic packaging Does not Documents to be submitted to the Competent Body B Declaration Design for recycling of plastic packaging Lt 4 Criterion 5 Sustainable sourcing of palm oil palm kernel oil and their derivatives Documents to be submitted to the Competent Body Included i Evidence of third party certification to relevant scheme or equivalent Completed spreadsheet for calculation Lot Declaration Sustainable sourcing of palm oil palm kemel oil and their derivatives Section 1 2 and or 3 as appropriate Supplier Declaration Sustainable sourcing of palm oil palm kernel oil and a their derivatives Criterion 6 Fitness foruse Documents to be submitted to the Competent Body iduded apply
74. support the declarationofnon classification i For substances that have not been registered under the REACH Regulation or which do not yet have a harmonised CLP classification Information meeting the re quirements listed in Annex VII to the REACH Regulation ii For substances that have been registe red under the REACH Regulation and which do not meet the requirements for CLP classification Information based on the REACH registration dossier confirming the non classified status of the substance iii For substances that have a harmonized classification or are self classified safety data sheets where available If these are not available or the substance is self classified then information shall be provided relevant to the substances hazard classification according to Annex II to the REACH Regulation iv In the case of mixtures Safety data sheets where available If these are not available then calculation of the mixture classification shall be provided according to the rules under Regulation EC No 1272 2008 together with information relevant to the mixtures hazard classification according to Annex II to Regulation EC No 1907 2006 Signature of person bearing legal responsibility Position held Company Stamp Version 1 0 Page 46 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU www ecolabel eu Declaration Criteria 3 b Hazard
75. t the criteria for classification with one or more of hazard statements or risk phrases listed in Table 3 in the form s and physical state s they are present in the product The following technical information related to the form s and physical state s of the ingoing substances and or mixtures as present in the product shall be provided to support the declaration of non classification i For substances that have not been registered under Regulation EC No 1907 2006 and or which do not yet have a harmonised CLP classification Information meeting the requirements listed in Annex VII to that Regulation ii For substances that have been registered under Regulation EC No 1907 2006 and which do not meet the requirements for CLP classification Information based on the REACH registration dossier confirming the non classified status of the substance iii For substances that have a harmonised classification or are self classified safety data sheets Version 1 0 Page 22 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU where available If these are not available or the substance is self classified then information shall be provided relevant to the substances hazard classification according to Annex Il to Regulation EC No 1907 2006 iv In the case of mixtures safety data sheets where available If these are not available then calcul
76. the product does not exceed the maximum limits set out below Shampoo shower preparations and liquid soaps l also confirm that CDV values have been calculated using the relevant CDV calculation spreadsheet please attach this to the application Please complete the table below to show actual CDV values as a result of this calculation Product Actual CDV Value please specify a product type e g shampoo Version 1 0 Page 41 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU Declaration Criterion 2 Biodegradability Applicant For the following product formulation iii the undersigned hereby declare that all surfactants are readily biodegradable under aerobic and biodegradable under anaerobic conditions as shown on the table below l also declare that that the total concentration mg g of Active Compound of non biodegradable not readily biodegradable aNBO and anaerobically non biodegradable anNBO ingoing organic substances does not exceed the following maximum concentrations aNBO anNBO mg g AC mg g AC z EE A T Ingoing substance other than a surfactant may be exempted from the requirement for anaerobic degradability if one of the following three alternatives is fulfilled 1 Readily degradable and has low adsorption A lt 25 2 Readily degradable and has high desorption D gt 75
77. to in Article 57 of Regulation EC No 1907 2006 In case the threshold for classification of a substance or mixture with a hazard statement differs from the one of a risk phrase than the former prevails The risk phrases in Table 3 generally refer to substances However if information on substances cannot be obtained the classification rules for mixtures apply Interpretation of criteria Risk phrases are a list of codes that designate the environmental or health risks associated with the substance Hazard statements are phrases which describe the nature of the hazard in a substance or mixture The risk phrases in Table 4 also generally refer to substances However if information on substances cannot be obtained the classification rules for mixtures apply Substances or mixtures which change their properties through processing and thus become no longer bioavailable or undergo chemical modification in a way that removes the previously identified hazard are exempted from criterion 3 b Interpretation of criteria Chemicals that undergo a reaction can be considered exempt from this criterion However the reaction products shall be declared and are subject to the conditions of this criterion Table 3 Hazard statements and Risk Phrases Hazard Statement Risk Phrase H300 Fatal if swallowed H310 Fatal in contact with skin R24 H311 Toxic in contact with skin H330 Fatal if inhaled R23 26 H331 Toxic if inhaled H341 S
78. tp ec europa eu environment ecolabel how to apply for eu ecolabel html Version 1 0 Page 10 of 77 Checklist How to apply Tick when complete Reference Requirement Ensure product is eligible for Ecolabel Web link Download the relevant product group criteria Identify the Competent Body in the relevant Member State you can apply to Contact the relevant Competent Body and notify them of your intention to apply for an Ecolabel Register with ECAT Admin Obtain application forms user manual from your Competent Body Revision Check to see if the criteria relating to your product s or service are due to be revised or updated in the near future 5 T If only submitting a change to products or suppliers identify the nature of the change and submit supporting documentation 3 For information about the criteria revision please visit the website http eceuropa eu environment ecolabel products groups and criteria html oi N EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Ecolabel Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Definitions The following definitions shall apply to references throughout this User Manual and in reference to the original Criteria document 1 ingoing substances means preservatives fragrances and colorants regardless of the concentration and other substances intentionally added by products and imp
79. uct group criterion Online reference link Outline of documentation needed for application including link to a template declaration form Criterion 7 Information appearing on the EU Ecolabel The optional label with text box shall contain the following text Reduced impact on aquatic ecosystems Fulfils strict biodegradability requirements Limits packaging waste The guidelines for the use of the optional label with text box can be found in the Guidelines for use of the Ecolabel logo on the website k Q http ec europa eu environment ecolabel documents logo guidelines pdf Required documentation for Assessment and verification Information appearing on the EU Ecolabel T The applicant shall provide a sample of the product label or an artwork of the packaging where the EU Ecolabel is placed together with a signed declaration of compliance T Declaration Information appearing on the EU Ecolabel Part C Application Form This application form should be completed by all applicants Version 1 0 Page 3 of 77 ie Na EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Ecolabe Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU www ecolabel eu Part D Declarations These declarations are to be completed as part of the application process The relevant sections of Part B Product Assessment and Verification should be referred to when co
80. ules under Regulation EC No 1272 2008 together with information relevant to the mixtures hazard classification according to Annex II to Regulation EC No 1907 2006 Signature of person bearing legal responsibility Company Stamp Version 1 0 Page 47 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU Declaration Criteria 3 b Hazardous substances and mixtures Exemption Applicant For the following product formulation iii the undersigned hereby declare that the following substances listed in Annexes IV and V to Regulation EC No 1907 2006 which are exempted from registration obligations under point a and b of Article 2 7 of that Regulation are present in the product Version 1 0 Page 48 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Declaration Criteria 3 b Hazardous substances and mixtures Derogation Applicant For the following product formulation oo ceecssssesusssevsssssscecssscscsssscsesmesssesesssuesesssessssssessesmssssssessensssseassssscsesssecieseecsaes the undersigned hereby declare that the following ingoing substances and mixtures fulfil the derogation conditions as outlined in Table 4 Derogated substances page 12 of the Decision 2014 893 EU Ingoing su Su
81. urities from raw materials the concentration of which equals or exceeds 0 010 by weight of final formulation This means that a active substances with dedicated function as preservatives fragrances or colorants re gardless of concentration b all other substances intentionally added by products and impurities from raw materials the concentration of which equals or exceeds 0 010 by weight of final formulation 2 active content AC means the sum of organic ingoing substances in the product expressed in grams calculated on the basis of the complete formulation of the product including propellants contained in aerosol products Rubbing abrasive agents are not included in the calculation of the active content 3 primary packaging means packaging in direct contact with the content conceived so as to constitute the smallest sales unit of distribution to the final user or consumer at the point of purchase in direct contact with the content 4 secondary packaging means packaging which can be removed from the product without affecting its characteristics and is conceived so as to constitute at the point of purchase a grouping of a certain number of sales units whether the latter is sold as such to the final user or consumer or whether it serves only as a means to replenish the shelves at the point of sale Version 1 0 Page 12 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel
82. uspected of causing genetic defects H350 May cause cancer 3 OJ L 353 31 12 2008 p 1 10 OJ 196 16 8 1967 p 1 Version 1 0 Page 20 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Hazard Statement Risk Phrase H350i May cause cancer by inhalation Fg a H351 Suspected of causing cancer H360F May damage fertility H360D May damage the unborn child R61 H360FD May damage fertility May damage the unborn child R60 61 60 61 H360Df May damage the unborn child Suspected of damaging fertility H36 1fd Suspected of damaging fertility Suspected of damaging the unborn R62 63 child H413 May cause long lasting harmful effects to aquatic life R53 EUHO59 Hazardous to the ozone layer EUHO29 Contact with water liberates toxic gas R29 EUHO31 Contact with acids liberates toxic gas R31 EUHO32 Contact with acids liberates very toxic gas R32 EUHO70 Toxic by eye contact R39 41 Sensitising substances Hazard Statement Risk Phrase H334 May cause allergy or asthma symptoms or breathing difficulties if R42 inhaled H317 May cause allergic skin reaction For rinse off cosmetic products the substances in Table 4 are exempted from the obligation in Article 6 6 of n Version 1 0 Page 21 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 20
83. vide a declaration of compliance with criterion 3 c together with related documentation such as declarations of compliance signed by the material suppliers and copies of relevant safety data sheets for substances or mixtures Reference to the list of substances identified as substances of very high concern shall be made on the date of application Declaration Ingoing substances listed in accordance with Article 59 1 of Regulation EC No 1907 2006 Supplier Declaration Ingoing substances listed in accordance with Article 59 1 of Requlation EC No 1907 2006 ini ini 3 d Fragrances i Products marketed as designed and intended for children shall be fragrance free Interpretation of criteria For the purpose of this criterion a child is defined as a person below the age of eighteen years unless under the law applicable to the child majority is attained earlier Part Article 1 of the U N General Assembly Convention on the Rights of the Child The manufacturer will need to provide an example of their product and marketing materials to show their intended target audience Use of words like baby infant child kid and plural thereof will indicate the intended market for the product ii Any ingoing substance or mixture added to the product as a fragrance shall be manufactured and handled following the code of practice of the International Fragrance Association IFRA The code can be found on the
84. xtures 11 nor to goods containing substances referred to in Article 57 of Regulation EC No 1907 2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration Evaluation Authorisation and Restriction of Chemicals REACH establishing a European Chemicals Agency Note that article 7 enables the Commission to adopt measures to grant derogations from paragraph 6 under certain conditions undertake to ensure that the product compiles with the EU Ecolabel criteria at all times and to notify ase J immediately of any significant modification to it or to the production processes take responsibility for the correct and proper use of the EU Ecolabel logo Signed Name in capitals Position in company Date Company stamp Insert name of Competent Body Version 1 0 Page 39 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU Part D Declarations Summary of declarations Click to view and print Criterion 1 Toxicity to aquatic organisms CDV Criterion 2 Biodegradability Criterion 3 a Specified excluded ingoing substances and mixtures Specified excluded ingoing substances and mixtures supplier declaration Criterion 3 b Hazardous substances and mixtures Part A Hazardous substances and mixtures Part B Hazardous substances and mixtures supplier declaration Exemption Hazardous substance
85. yvinylchloride Version 1 0 Page 30 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 89 3 EU Required documentation for Assessment and verification Design for recycling of plastic packaging B The applicant shall submit a signed declaration of compliance specifying the material composition of the packaging including the container label or sleeve adhesives closure and barrier coating and a sample of primary packaging B Declaration Design for recycling of plastic packaging Version 1 0 Page 31 of 77 EU ECOLABEL RINSE OFF COSMETICS USER MANUAL Commission Decision of for the award of the EU Ecolabel for rinse off cosmetics 2014 893 EU Criterion 5 Sustainable sourcing of palm oil palm kernel oil and their derivatives Palm oil and palm kernel oil and their derivatives used in the product must be sourced from plantations that meet criteria for sustainable management that have been developed by multi stakeholders organisations who have a broad based membership including NGOs industry and government Required documentation for Assessment and verification Sustainable sourcing of palm oil palm kernel oil and their derivatives B The applicant shall provide third party certifications that the palm oil and palm kernel oilused in the manufacturing of the product ingredient and or used as part of ingredient originates from sustain

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