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1、,New criteria for Nordic Ecolabelling of Cosmetics(version 2.0)Trine Thorup Andersen,Miljmrkning Danmark,Introduction,NEW CRITERIA overviewsHOW to compile applicationsWHAT documentation is required,Cosmetis 2.0 in general,Relevant documents on www.svanen.se&www.ecolabel.dk Comprise all kinds of cosm
2、etic productsShampoos/soaps/conditioners will get NEW license numbersImportant changes:Merging of criteria for Cosmetics+Shampoo/Soap/ConditionersMore environmental criteria for whole product,than based on function(new for leave-on products)Calculations based on long term aquatic toxicity for rinse-
3、off.Limitation of packaging material also for leave-onStricter criteria for content of hazardous substances health and environment.New declarations from raw material suppliers,New criteria overview(I),Not allowed or limited substancesR3:Environmentally hazardous limitationR5:Substances/groups,(new s
4、ubstances included)R6:Nano-materials/particles(100 nm)not allowed(possibly OK for TiO2 in sun screens if coming SCCS report says no cause for concern),R3:Environmentally hazardous substances,Maximum content of classified substances:100*cR50/53+10*cR51/53+cR52/53 2,5%(Typically:Fragrance substances,B
5、HT)BHT regarded as classified R50/53Zinc compounds(R50/53)may be in zinc ointment/zinc cream up to 25%Data gap on biodegradation,toxicity or bioaccumulation is treated as worst case=R50/53,R5:Not allowed substances,D4(octamethylcyclotetrasiloxane)&D5(decamethylcyclotetrasiloxane)TriclosanParabenesPB
6、T&vPvB substances from EU list,New criteria overview(II),Biodegradation and aquatic toxicityA)Rinse-off(sum of all organic ingredients)R8:Limit on amount of organics that do not biodegrade aerobically(aNBO)and/or anaerobically(anNBO)(modified,stricter)R9:CDV(Critical Dilution Volume)(modified,strict
7、er)B)Other products(Leave-on)(min.95 weight%of organic ingredients)R10:Biodegradability and Aquatic toxicity,R10:Biodegradability and aquatic tox.(leave-on),Min.95%of organic substances(except:UV filters in sun screens and fibers in wet wipes)must be either:readily biodegradable(OECD 301,OECD 310)or
8、 lowest EC/LC50 10 mg/l and not bioavailable(MW 700 g/mol)or lowest EC/LC50 10 mg/l and not bioaccumulative(logKow 4 or BCF 500)or lowest EC/LC50 10 mg/l and inherently biodegradable(OECD 302),New criteria overview(III),Colorants/dyesR11:May not be bioaccumulative(logKow 4 or BCF 500)OR must be appr
9、oved in foodstuffs.R12:Max content of metals Ba,Pb,Hg,Cd,Bi,Cr:10 ppm Covered by new Regulation but no lower limit for impurities.FragrancesR14:No fragrances,aromas or fragrances from plant extracts in products for baby or kidsR15:Max content of allergens(26-list+R43 classified):100 ppm in rinse-off
10、;10 ppm in leave-on(modified,easier)PreservativesR17:May not be bioaccumulative(logKow 4 or BCF 500)PolymersR20:Max content 100 ppm of af harmful monomers in fresh polymer(CMR,sensitizing,hormone disrupting,R50/53,R51/53),R14:Fragrances and baby/kids products,Fragrances/aromas/fragrance substances i
11、n plant extracts may not be added to products for infants/baby/junior/kids=Products marketed to people aged 0-12 years.Natural based ingredients,non-scenting,not for fragrance/aromatic purpose such as Aloe Vera,neutral oils/fats,butters etc.may still be used.Case-by-case assessment.,New criteria ove
12、rview(IV),Requirements for specific products:R22Solid soap:Max content of EDTA/EDTA salts(new level)R23Lip and oral products:Aroma,colorants and preservative must be approved for foodstuffs(new legislation in development)R24Hair dyes:Lawson may not be used.Dyestuffs assessed as sensitizing by SCCS m
13、ay not be used(modified),New criteria overview(V),Packaging(primary packaging only):R27:Amount of packaging vs product volume(see next slide)R28:Type of material:mono-material(plastic,metal,glass)parts separableR30:Metal cans(aerolsols)allowed for hair styling and shaving foam onlyR31:Paper/board,no
14、t chlorine gas bleachedR32:Dosing facility assure non-overdosing,max dose for pumps and dispensers(soaps)R36:Marketing claims for products with organic/bio/kologisch/ekologicalingredients,R27:Packaging amount vs product volume,Packaging shall overhold calculation in the criteria.Only 2 layers of pac
15、kaging is allowed(e.g.can in box,tube in box).Leaflets are allowed but must be included.Type in parameters in ready-to-use calculation sheet!(product volume vs weight and recycled content of packaging components)Note:Different materials are weighted based on their impact from an LCA view:glasspaper/
16、boardplastic laminatesother materials(incl.HDPE,PP,PET etc.),New criteria overview(VI),Performanca:R37:Performance/Quality,documentation(modified)R38:Sun screens UVA and UVB protectionR39:Toothpaste,fluorine content must follow national recommendations.Alternatively for non-fluorine:Documentation fo
17、r procection level as good as fluorine pastes(new)Quality®ulatoryR40-R46:Traceability,responsibility,notification by changes etc.Recycling and marketingR47:Relevante regler,love og/eller brancheaftaler vedr.returR48:Markedsfring skal ske i hht Nordisk Miljmrknings regler,R37:Performance,The perfo
18、rmance and quality of the product must be satisfactory.This can be demonstrated through relevant testing.Testing must at a minimum test the characteristics with which the product is marketed.If there is a recognised test method(see for example R38 for sunscreen products),this shall be used.For other
19、 products,a test could be the manufacturers internal quality test,a consumer test with test group of 10 or more independent individuals,or a comparative test relating to a similar product,e.g.a triangle test.The Colipa(European Cosmetics Association)guidelines on Efficacy Evaluation of Cosmetic Prod
20、ucts must be observed.Description of test,including an account of chosen testing methods and test results.If a consumer test is used a copy of completed and signed test reports is to be supplied.This report shall include a description of the test group,the number of participants and a summary of tes
21、t results.Appendix 3 or equivalent declaration duly completed and signed.,Declarations from raw material suppliers,Appendix 4,N.B.Declarations(new):For documentation of requirement on ingredient classification and absence of certain substances,Appendix 4 must be completed by the raw material supplie
22、rs.This applies for all suppliers and raw materials!,How to make the dossier,We prefer electronic documentsExample of dossier out-line01 Application/correspondance02 Information on product03 Recipes/formula,Appendix 304 Calculations05 Safety Data Sheets,Appendix 4,Appendix 506 Packaging,calculations
23、,Appendix 6,Take-back systems07 Performance08 Art-work/labels,Appendix 109 Quality and regulatory requirements10 Other relevant documentation,Which documentation must be submitted for license renewal?,As a rule we need almost all documentation sent in:Applications and declarationsRecipes and calcula
24、tions(MSDS,see below)Packaging specifications(type,material,weight)Art-work/labels(Performance,see below)(QA procedures,see below)Exceptions:MSDS:If updated and newly sent in,case-by-case assessmentQA procedures:If only about 3 years old and conditions unchanged,case-by-case assessmentPerformance:If rather newly sent in and product unchanged,case-by-case assessmentPackaging samples could be submitted if we specifically ask for them,
