Nordic Ecolabelling of Cosmetic products

Transcription

1 rdic Ecoabeing of Cosmetic products Version October June 2017 rdic Ecoabeing

2 Content What is a rdic Ecoabeed cosmetic product? 3 Why choose the rdic Ecoabe? 3 Which cosmetic products may carry the rdic Ecoabe? 4 How to appy 4 What are the requirements of the rdic Ecoabe? 5 1 Environmenta and heath requirements Genera requirements (appicabe to a products) Specific requirements reating to certain product types 14 2 Packaging 16 3 Consumer information requirements 18 4 Performance/quaity requirements 20 5 Quaity and reguatory requirements 21 6 Take-back system and marketing 22 Marketing 22 Design of the rdic Ecoabe 22 Foow-up inspections 23 How ong is a icence vaid? 23 New criteria 24 References 25 Appendix 1 Marketing of rdic Ecoabeed cosmetic products Appendix 2 Test methods and documentation of environmenta characteristics Appendix 3 Decaration from the cosmetic product producer Appendix 4 Decaration from the primary producer Appendix 5 Decaration from the producer of fragrances, aromatic substances and pant extracts regarding ingredients in fragrance bends/aromatic substances/pant extract Appendix 6 Decaration from the packaging producer Appendix 7 Cacuations Appendix 8 Minimum requirements for the content in test reports as documentation of performance/quaity 090 Cosmetic products, version 2.10, 4 June 2015 This document is a transation of an origina in Swedish. In case of dispute, the origina document shoud be taken as authoritative. Addresses In 1989, the rdic Counci of Ministers decided to introduce a vountary officia ecoabe, the rdic Ecoabe. These organisations/companies operate the rdic ecoabeing system on behaf of their own country s government. For more information, see the websites. Denmark Ecoabeing Denmark Danish Standards Foundation Portand Towers Göteborg Pads 1 DK-2150 rdhavn Phone Fax E-mai: info@ecoabe.dk Sweden Ecoabeing Sweden Box SE Stockhom Phone E-mai: svanen@ecoabe.se rway Ecoabeing rway Henrik Ibsens gate 20 NO-0255 Oso Phone E-mai: info@svanemerket.no Finand Ecoabeing Finand Box 489 FIN Hesinki Phone E-mai: joutsen@ecoabe.fi Iceand Ecoabeing Iceand Umhverfisstofnun Suðurandsbraut 24 IS-108 Reykjavik Phone Fax E-mai: svanurinn@ust.is This document may ony be copied in its entirety and without any kind of ateration. It may be quoted from provided that rdic Ecoabeing is stated as the source.

3 What is a rdic Ecoabeed cosmetic product? rdic Ecoabeed cosmetic products are among the east environmentay hazardous products within their category and they fufi both environmenta and heath reated requirements. Requirements are set on chemica cassification and environmenta characteristics, on the use of fragrances and coouring agents, on packaging and on product performance. Products enter the waste water system foowing their use, either directy, such as soaps, shampoo and toothpaste, or indirecty through washing, such as otions, creams, hair stying products and make-up. Properties such as biodegradabiity, bioaccumuation and toxicity to aquatic organisms are therefore highy reevant to a ingredients. Regarding shampoo and soap, this appies in particuar to surfactants which are the most important substances in the products from the point of view of quantities and function. Cosmetic products come into direct contact with the body. They shoud therefore contain as few irritating, sensitising or in any other way harmfu ingredients and impurities as possibe. The heath requirements focus on aergies and other possibe serious effects. This is achieved by imposing requirements on the properties of individua substances and the imitation of specific substances. rdic Ecoabeing of cosmetic products guarantees, among other things, that: Minima amounts of environmentay hazardous substances are contained in the products. Strict requirements are set in regard to the permissibe eves of biodegradabiity, toxicity and bioaccumuative potentia of a product s constituent substances. Products aimed at chidren are perfume free. Use of packaging materias is reduced. Why choose the rdic Ecoabe? Products may carry the rdic Ecoabeing trademark for marketing purposes. The rdic Ecoabe is a very we-known and we-reputed trademark in the rdic region. rdic Ecoabeing is a simpe and cost-effective way of communicating environmenta concerns and commitment to purchasers and consumers. Environmenta issues are compex. It can take a ong time and extensive resources to gain an understanding of a specific area. rdic Ecoabeing faciitates this process. The rdic Ecoabe not ony covers environmenta issues but aso quaity requirements, since environmenta and quaity concerns often go hand in hand. This means that a rdic Ecoabe icence can aso be seen as a mark of quaity. rdic Ecoabeing of Cosmetic products (25)

4 Which cosmetic products may carry the rdic Ecoabe? A cosmetic products that are encompassed by Counci Directive 76/768/EEC on cosmetics with subsequent amendments and adaptations (see Artice 1), and Cosmetics Reguation 1223/2009/EG for exampe skin care products, hair care products, decorative cosmetics, perfumes and sanitary products, can be rdic Ecoabeed. Rinse-off products for animas, which are not covered by the cosmetics directive, are eigibe for rdic Ecoabeing. Products within the remit of the Biocida Products Directive (Directive 98/8/EC) can not be rdic Ecoabeed. How to appy The appicant sha refer to the Reguations for the rdic Ecoabeing of products and the ecoabeing requirements in this document. Each requirement is marked with the etter R (requirement) and a number. To be awarded the rdic Ecoabe, a genera requirements and appicabe product-specific requirements in this document must be fufied. Icons in the text The text describes how the appicant sha demonstrate fufiment of each requirement. There are aso icons in the text to make this cearer. These icons are: ( Encose Requirement checked on site Appication Appications sha be made to rdic Ecoabeing in the country in which the cosmetic product is to be sod or in which the appicant keeps its base of operations, see the address ist on page 2. Appications consist in an appication form and documentation of compiance (specified in the requirements). Further information and assistance may be avaiabe. Visit the Web site of the reevant nationa ecoabeing body for more information. Saes in other rdic countries Registering a icence in another rdic country aows the rdic Ecoabe to be used in a arger market. The foowing must be submitted to rdic Ecoabeing: Appication form for registration or origina rdic Ecoabe appication*. Copy of icence. rdic Ecoabeing of Cosmetic products (25)

5 Copy of the abe in the appicabe oca anguage. Documentation demonstrating that particuar nationa egisation is fufied in the country of appication (e.g. recycing systems or recommended fuorine content in toothpaste). Any marketing materia for the country of registration. The suppier/distributor in the country of registration, when other than the icensee. *If the appicant states during the initia appication that they intend to register the product in other rdic countries, it is not necessary to submit additiona materia (see above) at registration. In such cases, rdic Ecoabeing coates and forwards the documentation to the country or countries in question. Registration is free of charge but an annua fee sha be paid in accordance with the nationa reguations. On-site inspection During the appication process, rdic Ecoabeing normay performs an onsite inspection to ensure adherence to the requirements. For this inspection, data used for cacuations, origina copies of submitted certificates, ists of ingredients, test records, purchase statistics, and simiar documents that support the appication must be avaiabe for examination. Costs An appication fee is charged to companies appying for a icence. There is an additiona annua fee based on the turnover of the rdic Ecoabeed cosmetic product. Enquiries Pease contact rdic Ecoabeing if you have any queries or require further information. See page 2 for addresses. What are the requirements of the rdic Ecoabe? To be awarded a rdic Ecoabe icence, a genera requirements and appicabe product-specific requirements in this document must be fufied. rdic Ecoabeing of Cosmetic products (25)

6 1 Environmenta and heath requirements The requirements in this section appy to a constituent substances uness specified otherwise. The term constituent substance refers to a substances in the product, incuding additives in the ingredients (such as preservatives and stabiisers), with the exception of impurities from primary production. Impurity refers to residues from primary production which may be found in rinse-off that are at concentrations beow 0.01% (100 ppm) and in eave-on products at concentrations beow 0.001% (10 ppm), provided the impurity has not been activey added and/or added for a particuar purpose. Impurities of over 1.0% concentration in the raw materia/ingredient are, however, regarded as constituent substances. Substances known to be degradation products of the constituent substances are aso themseves considered to be constituent substances. 1.1 Genera requirements (appicabe to a products) A requirements aid out in section 1.1 must be met except for requirements R8-10, where differentiated requirements in regard of products rinsed in water (R8-9) versus other cosmetic products (R10) are set. Are the requirements met? R1 Decaration of content The exact formuation for the product sha be submitted to rdic Ecoabeing. ( Exact formuation specifying the constituent substances chemica name, trade name, DID (Detergents Ingredients Database) number (if any), INCI (Internationa mencature of Cosmetic Ingredients) name, CAS number (if any), quantity in the product incuding and excuding water, as we as the function performed by the constituent substance in question. If an ingredient contains severa substances, data for each constituent substance sha be presented. If information about the composition of ingredient is confidentia, this information can be sent directy to the ecoabeing body. ( Safety data sheet for each ingredient in compiance with appicabe egisation in the country of appication, e.g. Annex II of REACH (Counci Reguation 1907/2006/EEC). rdic Ecoabeing of Cosmetic products (25)

7 Constituent substances The foowing requirements appy to a constituent substances and for their known degradation products. R2 Cassification of constituent substances Constituent substances cassified according to Tabe 1 are prohibited. Tabe 1 Cassification of constituent substances Cassification Hazard symbos and risk phrases according to 67/548/EEC 1 Hazard category and statement according to 1272/2008/EEC 2 Sensitizing* Xn with R42 or Xi with R43 Resp. sens. 1 with H334 or Skin sens. 1 with H317 Carcinogenic Carc with R40, R45 and/or R49 Carc 1A/1B/2 with H350, H350i and/or H351 Mutagenic Mut with R46 and/or R68 Mut 1B/2 with H340 and/or H341 Reproductive toxic Repr with R60, R61, R62, R63 and/ or R64 *See the separate requirements on perfumes and enzymes (R15 and R21). 1 Counci Directive 67/548/EEC is appicabe unti 1 December 2010 and during the transition period Reguation 1272/2008/EEC is appicabe from 1 December ( Safety data sheet for each ingredient in compiance with appicabe egisation in the country of appication, e.g. Annex II of REACH (Counci Reguation 1907/2006/EEC). ( Appendix 3 and 4 or equivaent decarations duy competed and signed. Repr 1A/1B/2 with H360F, H360D, H361f, H361d, H360FD, H361fd, H360Fd, H360Df, Lact. H362 R3 Environmentay hazardous substances The foowing imits appy to substances that are cassified as environmentay hazardous according to Reguation 1272/2008/EEC (as of 1 December 2010) or Counci Directive 67/548/EEC (unti 1 December 2010 and during the transition period ). 100 c H c H411 +c H % / 100 c R50/ c R51/53 +c R52/53 2.5% where c i is the fraction of the product, measured in percentage by weight, made up of the cassified substance. BHT is considered to be cassified under R50/53/H410 Zinc oxide paste/ointment/cream marketed for use in the treatment of eczema may, however, contain compounds of Zinc (cassified under R50/53/H410) in concentrations up to 25%, and in these cases may be exempted from the requirement. Surfactants in rinse-off products cassified with H411 or H412 are exempted from the requirement, provided that they are readiy degradabe* and anaerobicay degradabe**. * In accordance to the DID-ist. If the substance in not on the DID-ist documentation must be according to test method. 301 A-F or. 310 in OECD guideines for testing of chemicas or other equivaent test methods. ** In accordance to the DID-ist. If the substance in not on the DID-ist documentation must be according to ISO 11734, ECETOC. 28 (June 1988) or other equivaent test methods, where a minimum of 60% degradabiity under anaerobic conditions is achieved. ( Decaration of surfactants that are exempted from the requirement (quantity, cassification, degradabiity). ( A decaration of potentia dangers posed to the environment (acute toxicity, biodegradabiity and/or bioaccumuative potentia), in the form of either a product safety data sheet (1907/2006/EC/2001/58/EC) or other equivaent documentation. ( Decaration of the quantity (in per cent by weight) of R50/53, R51/53 and R52/53 or H410, H411 and H412. If data regarding the potentia environmenta hazards posed by a substance (biodegradabiity, toxicity and bioaccumuation) has not been assessed, the substance is treated according to a worst case scenario (R50/53/H410). rdic Ecoabeing of Cosmetic products (25)

8 R4 SCCS opinions The recommendations of the EU s Scientific Committee on Consumer Safety (known as SCCS Opinions ) are to be foowed at a times. In those cases in which these recommendations are not in agreement with the requirements set out in this document, the more restrictive requirement is to appy. SCCS recommendation, SCCS/1459/11 on Fragrance Aergens, is exempted from this requirement. However HICC, choroatrano and atrano are prohibited in the product. The exception is vaid unti 30 June SCCS Opinions may be viewed at: ( Appendix 3 or equivaent decaration duy competed and signed. ( Appendix 5 or equivaent decaration duy competed and signed. R5 ( Recipe. Prohibited substances The foowing substances are prohibited from use in the product and ingredients: D4 (octamethycycotetrasioxane, CAS ) and D5 (decamethycycopentasioxane, CAS ) Borates and perborates Nitromusk and poycycic musks EDTA (Ethyenediaminetetraacetic acid) and its sats (see however the exemption for soid soap under R22). Tricosan Parabens (4-Hydroxybenzoic acid and its sats and esters) Substances considered potentia endocrine disrupters in accordance with European Union reports on endocrine disrupters (see Appendix 2 for a definition). The European Union reports on potentia endocrine disrupters can be read in fu at Substances that have been evauated in the EU to be PBT (Persistent, bioaccumuabe and toxic) or vpvb (very persistent and very bioaccumuabe) (see Micropastics* *Micropastics are defined as undissovabe pastic partices of ess than 1mm size and not biodegradabe according to OEC 301 A-F. te the nationa egisations concerning PFOA in the rdic countries. In rway PFOA is reguated in «Forskrift om begrensning i bruk av hese- og mijøfarige kjemikaier og andre produkter (produktforskriften)», ( Appendix 3 and 4 or equivaent decarations duy competed and signed. Nanomaterias/partices R6 ( Recipe. Nanomaterias/partices Nanomaterias/partices (insoube or biopersistent and intentionay manufactured materias with one or more externa structure in size nm) are prohibited. Excepted from this requirement is hydrated siica used as abrasives in toothpaste. If documentation is pubished by the SCCS demonstrating that the use of specific nanomaterias/partices in sunscreen products does not give rise to concerns in respect of heath, then such specific nanomaterias/partices additionay may be approved for use as sun fiter in sunscreen products. This means that a UV-fiter can ony be used when it is isted in Annex VI of Cosmetics Reguation 223/2009/EG. ( Appendix 3 and 4 or equivaent decarations duy competed and signed. rdic Ecoabeing of Cosmetic products (25)

9 Biodegradabiity and aquatic toxicity A products are required to fufi R7. A products rinsed off with water immediatey after use (e.g. shampoo, conditioner, shower ge, soid and iquid soap, ceanser, exfoiant, bath ge/foam, hand soap for industry and ceansing ge) (A) must fufi the requirements R8 and R9. Other cosmetic products (B) are required to fufi R10. R7 Surfactants A surfactants must be readiy aerobicay and anaerobicay biodegradabe, regardess of their function. However, emusifiers and softeners are exempted from the requirement for anaerobicay biodegradabe. Regarding toothpaste, a detersive surfactants must be readiy aerobicay biodegradabe. Toothpaste must not contain Sodium aury suphate (SLS). ( Reference to the DID ist, approved version from January 2007 or ater. If the substance is not isted on the DID ist, the parameters sha be cacuated in accordance with the guideines in section B of the DID ist, and the associated documentation sha be submitted. DID ist: Detergent Ingredient Database ist. See Appendix 2 for further information. ( Toothpaste: Appendix 3 or equivaent decaration duy competed and signed. A) Products rinsed off with water immediatey after use (e.g. shampoo, conditioner, soid and iquid soap, ceanser, exfoiant and bath foam/ ge, hand soap for industry and ceansing ge). R8 anbo (Aerobic n-biodegradabe Organics) and annbo (Anaerobic n-biodegradabe Organics) Organic substances (see separate requirement R7 regarding surfactants) that are not readiy biodegradabe according to Appendix 2, must not be present in the product in excess of the imits indicated in Tabe 2. The requirement appies to products that, according to their instructions for use, are rinsed off with water immediatey after use. For iquid soap and hand soap for industry it is permitted to choose between appying the imits per active content or per dose. The unit used sha be the same as in R9. Tabe 2 Threshod vaues for anbo and annbo Type of product anbo (mg/g AI) annbo (mg/g AI*) Liquid soap, hand soap for industry, shampoo, shower ge, conditioner, bath foam, ceanser, exfoiant Soid soap 5 5 annbo (mg/dose**) Liquid soap 2,5 2,5 Liquid hand soap for industry*** 6 6 annbo (mg/dose**) * Active ingredients (AI) refers to the dry weight of a organic substances in the product. Abrasives in handwash and exfoiants are not incuded. **One dose = the quantity dispensed per fu depression by the dispenser or pump suppied with/designed for the product (0.5g minimum). If the product is not sod with a particuar dispenser, a standardised dose of 0.75 g for foam soap, 1.5 g for other iquid soap and 4 g for hand soap for industry is used *** The product must be ceary abeed that it is intended for ceaning severey soied hands in the context of industry or simiar. rdic Ecoabeing of Cosmetic products (25)

10 ( Cacuation of the quantity (mg) of anbo and annbo per gram AI per dose. Reference to the DID ist, approved version from January 2007 or ater. If the substance is not isted on the DID ist, the parameters sha be cacuated in accordance with the guideines in section B of the DID ist, and the associated documentation sha be submitted. DID ist: Detergent Ingredient Database ist. See Appendix 2 for further information. R9 Critica diution voume (CDV) The product s critica diution voume (CDV) must not exceed the imit vaues in Tabe 3 for CDV chronic for the product type in question. The requirement appies to products that, according to their instructions for use, are rinsed off with water immediatey after use. Regarding iquid soap and hand soap for industry it is permitted to choose between appying the imits per active content or per dose. The unit used sha be the same as in R8. Tabe 3 Threshod vaues for CDV Type of product Liquid soap, hand soap for industry, shampoo, shower ge, conditioner, bath foam, ceanser, exfoiant CDV chronic (/g AI*) Soid soap Liquid soap Liquid hand soap for industry*** CDV chronic (/dose**) The cacuation of CDV is based on information provided regarding the toxicity and biodegradabiity of the individua substances in an aquatic environment. CDV is expressed as itre/gram of AI or itre/dose, and is cacuated for a substances in the product using the formua given in Appendix 8. *Active ingredient(s) (AI) **One dose = the quantity dispensed per fu depression by the dispenser or pump suppied with/designed for the product (0.5g minimum). If the product is not sod with a particuar dispenser, a standardised dose of 0.75 g for foam soap, 1.5 g for other iquid soap and 4 g for hand soap for industry is used *** The product must be ceary abeed that it is intended for ceaning severey soied hands in the context of industry or simiar. ( Cacuation of CDV chronic for the product. (A spreadsheet for this cacuation is avaiabe from rdic Ecoabeing). Reference to the DID ist, approved version from January 2007 or ater. If the substance is not isted on the DID ist, the parameters sha be cacuated in accordance with the guideines in section B of the DID ist, and the associated documentation sha be submitted. DID ist: Detergent Ingredient Database ist. See Appendix 2 for further information. rdic Ecoabeing of Cosmetic products (25)

11 B) Other cosmetic products R10 Biodegradabiity and aquatic toxicity At east 95% by weight of the tota content of organic constituent substances (with exceptions for UV fiters in sunscreen and fibre materia in wet wipes) must be (see, however, separate requirement R7 in respect of detersive surfactants): readiy biodegradabe (OECD 301 A-F), and/or owest recorded aquatic toxicity EC/LC 50 > 10 mg/ and not be bioavaiabe (moar weight > 700 g/moe), and/or owest recorded aquatic toxicity EC/LC 50 > 10 mg/ and not be bioaccumuabe (ogk ow < 4 or BCF < 500), and/or owest recorded aquatic toxicity EC/LC 50 > 10 mg/ and be inherenty biodegradabe (OECD 302 A-C). ( Cacuation as above as we as reference to DID ist. For substances not isted on the DID ist a specification is required of biodegradabiity/toxicity/ potentia for bioaccumuation/bioavaiabiity according to Appendix 2. (The owest avaiabe EC/LC50 vaue must be used). Dye R11 Bioaccumuation Organic coouring agents must not be bioaccumuating according to Appendix 2, item 4 (BCF<500/ogK ow <4). Aternativey, the coouring agent must be approved for use in food stuffs. ( Specification of empiricay determined BCF vaue (bioconcentration factor) or ogk ow vaue (ogarithmic octano-water partition coefficients), see description in Appendix 2. Aternativey, an E-number (number designated on approva of foodstuff status) may be suppied. Appendix 3 and 4 can be used. R12 Metas Barium, ead, mercury, cadmium, bismuth and hexavaent chromium must not be present in coouring agents in concentrations above 10 ppm (0.001 %). Coouring agents that are approved for use in food stuffs according to the European Commission s Directive 2008/128/EC can be used without additiona documentation. ( Appendix 4 or equivaent decaration duy competed and signed and/or specifications/anaysis resuts for the dye. ( Specification of E-number and/or decaration from the suppier of the coouring agent conforming that the coouring agent meets the criteria for purity according to the European Commission s Directive 2008/128/EC. Fragrances Requirements appy aso to aromatic substances and fragrances in pant extract. R13 IFRA Fragrances must be used in accordance with the IFRA guideines. The IFRA (Internationa Fragrance Association) guideines can be read at ( Appendix 3 or equivaent decaration duy competed and signed. rdic Ecoabeing of Cosmetic products (25)

12 R14 Infant, baby and chid products Fragrances/ fragrance substances/aromatic substances/fragrance substances in pant extract must not be added to infant, baby and/or chid products. Infant, baby and/or chid products refers to products that are marketed as designed for infants, babies and/or chidren (<12 years od) or have any of these words on the abe/ packaging. te that the 26 fragrance substances subject to decaration are incuded in this requirement. ( Appendix 3 and 4 or equivaent decarations duy competed and signed. ( Recipe. ( Sampe of a abe. R15 Quantity of fragrance A fragrance/aromatic substance/fragrance substance in pant extract that is cassified as sensitising with risk phrase R43 (H317) and/or R42 (H334), or is one of the 26 fragrances subject to decaration, must not be present in quantities greater than 0.001% (10 ppm) in eave-on products or 0.01% (100 ppm) in rinse-off products. ( Appendix 5 or equivaent decaration duy competed and signed. Specification of the fragrance(s). ( Recipe. Preservatives These requirements appy to antibacteria, disinfecting and microbia substances. R16 Use of preservatives The use of preservatives for purposes other than preservation of the product itsef is prohibited. ( Appendix 3 and 4 or equivaent decarations duy competed and signed. R17 Bioaccumuation Preservatives must not be bioaccumuating as specified by Appendix 2, item 4 (BCF<500/ogK ow <4). ( Specification of BCF or ogk ow vaue. See description in Appendix 2. Appendix 3 and 4 may be used. UV-fiter R18 Function of the UV-fiter UV-fiters must ony be added to eave-on products and ony to protect the user - not the product. Products for which caims in regard to UV protection functionaity are made must fufi requirement R38, Performance, UVA and UVB protection. ( Appendix 3 and 4 or equivaent decarations duy competed and signed. rdic Ecoabeing of Cosmetic products (25)

13 R19 Environmenta characteristics of the UV-fiter A organic UV-fiters contained in the product: must not be bioaccumuating as specified by Appendix 2, item 4 (BCF<500/ogK ow <4), or must have a owest recorded eve of toxicity of EC/LC 50 > 10.0 mg/. ( Specify one of the foowing vaues: BCF vaue/ogk ow vaue/owest EC/LC 50 vaue (The owest avaiabe EC/LC 50 vaue must be used). Poymers R20 Content of monomers Poymers must contain ess than 100 ppm of monomers, measured on the newy produced poymer dispersion, if the monomer is cassified as CMR (Carcinogenic, Mutagenic, toxic for Reproduction), see R2 for R-phrases/ -hazard statements, sensitising with R42 and/or R43 (H334, H317), environmentay hazardous with R50/53 or R51/53 (H410/H411) or as a potentia endocrine disrupter (see Appendix 2 for definition). ( Specification of residua monomers in the poymer that are cassified as stated in the requirement. Decaration from the poymer producer that the requirement is fufied, e.g. through specifications and/or anaysis resuts. Enzymes R21 Cassification of enzymes Enzymes must be encapsuated as granuates or iquids. Powdered enzymes can be used provided that: - The fina product is a dust-free product (excudes powdered or dust products and simiar) - Manua handing of powdered enzymes sha be carried out in a specia, shieded area (for exampe weighing room or fume cupboard with ventiation) - Specia work instructions sha be avaiabe concerning use of persona protective equipment and concerning coection and remova of any spiage of powdered enzymes that may occur - Everyone that handes enzymes sha use protective cothing, goves, mask with dust fiter (minimum P3 1 dust fiter) and protective gasses Enzyme preparations may be added even when containing substances cassified as sensitising with R42 (H334) and/or R43 (H317). Use of enzymes in spray products is prohibited. ( Statement from the enzyme producer or information on safety data sheet/ product specification concerning the shape of the enzyme. Specia for powdered enzymes: documentation regarding handing of powdered enzymes in production as it is specified in the requirement. ( Decaration from the producer of spray products that enzymes have not been added, Appendix 3 may be used. 1 Respirator with P3 dust fiter protects against most types of harmfu dust. These fiters can protect ony against soid partices or against both soid partices and iquid aerosos. The fiter aso protects against radioactive dust, bacteria and virus (Ref: Branchearbejdsmijørådets håndbog for sikkerhedsgruppen bygge og anæg, 2008). rdic Ecoabeing of Cosmetic products (25)

14 1.2 Specific requirements reating to certain product types The foowing requirements appy ony to the product types stated. It shoud be noted that each and every requirement in section 1.1 must be fufied (see, however, the exemptions aid out in the differentiated requirements in regard to rinse off products versus other cosmetic products, R6-R10). Soid soap R22 Content of EDTA and phosphonates in soid soap Ethyene diamine tetraacetate (EDTA) and its sats (e.g. CAS no ) are permitted in soid soap. The tota added quantity of EDTA, EDTA sats and phosphonates must not exceed 0.6 mg/g AI. ( Cacuation of the quantity (mg) of EDTA and phosphonates per gram of AI. Lip products, toothpaste and ora hygiene products R23 Favourings, coouring agents and preservatives Favourings, coouring agents and preservatives used in these products must be approved for use in foodstuffs. ( Specification of E number and/or decaration from suppier of favouring stating that the favouring is approved for use in foodstuffs according to 88/388/EC (EU, 1988). Hair dyes R24 Hair dyes Use of awsone (CAS no ) is prohibited. Hair dyes considered to be sensitising/aergenic by the SCCS may not be incuded in the product, even if they are not cassified as such with R43 (H317) and/or R42 (H334) ( Appendix 3 or equivaent decaration duy competed and signed. rdic Ecoabeing of Cosmetic products (25)

15 Sanitary products, wet wipes R25 Materias The materias used in wet wipes must meet at east one of the requirements beow for the reevant type of fibre (other fibre types may not be used): Viscose, non-woven, poymers (PE, PP, PET): Requirements regarding the reevant materia in Section 2 of rdic Ecoabeing s criteria for sanitary products, version 5.0 or ater. N.B. The requirement appies aso to viscose/non-woven materias based on bamboo fibres. Paper/ceuose: Materias must be icensed to carry the rdic Ecoabe according to, or otherwise fufi the requirements in the criteria for rdic Ecoabeing of tissue paper (version 4.0 or ater), or have been awarded the European Ecoabe for tissue paper according to the criteria adopted in 2009 (2009/568/EC) or ater. Textie fibres (e.g. cotton, inen, jute, hemp, bamboo): Textie fibres used in the manufacture of rdic Ecoabeed wet wipes must be icensed according to, or otherwise fufi the requirements in the criteria for rdic Ecoabeing of textie products (version 3.0 or ater), or the EU Ecoabe for textie products according to the criteria adopted in Juy 2009 (2009/567/EC) or ater. ( Paper: A copy of the rdic Ecoabe icence; or documentation as required according to the criteria for tissue paper (version 4.0 or ater); or a contract in respect of the EU Ecoabe from a competent body. Textie fibres: A copy of the rdic Ecoabe icence; or documentation as required according to the criteria for texties (version 3.0 or ater); or a contract in respect of EU ecoabeing from a competent body ; or documentation as required according to the criteria for the EU Ecoabe for textie products as adopted in Juy 2009 (2009/567/EC) or ater. Aternatives for viscose, non-woven, poymers(pe, PP, PET): Documentation as specified in the criteria for sanitary products (version 5.0 or ater) or a copy of the rdic Ecoabe icence with information regarding approved materias for rdic Ecoabeed hygiene products. Rinse-off products for animas R26 Fragrances and coouring agents in rinse-off products for animas Fragrances and coouring agents may not be incuded in rinse-off products intended for use on animas. Products must compy with cosmetics reguations (76/768/EEG, with subsequent amendments and adaptations (see Artice 1) and 1223/2009/EG) in regard to their constituent substances and decaration thereof. ( Appendix 3 or equivaent decaration duy competed and signed. ( Sampe of a abe. rdic Ecoabeing of Cosmetic products (25)

16 2 Packaging Are the requirements met? A requirements appy ony to primary packaging, incuding abes and information sheets, but not incuding printer s ink. The term primary packaging refers to packaging conceived so as to constitute a saes unit to the fina user or consumer at the point of purchase, e.g. toothpaste tubes and their box packaging or the pastic packaging hoding together 2 bottes of shampoo (2-pack shampoo); i.e. packaging materias used in dispays or in goods transportation are not incuded. R27 Quantity of packaging The packaging must fufi the terms of the foowing cacuation. See further information and exampe cacuations in Appendix 8. A maximum of two ayers of packaging is permitted. (A spreadsheet for this cacuation is avaiabe from rdic Ecoabeing.) mf i = materia factors for various types of materia are assigned to the foowing four groups: mf gass = 0.2 mf paper/cardboard = 0.6 mf pastic aminate = 1.1 mf other materias = 1.0 Weight materia = weight of the packaging unit (inc. abe and info sheet) in grams. rf i = fraction of materia recyced foowing consumer use. Weight pump = weight of pump (if appicabe) in grams. t = reuse factor n = natura ogarithm Vo product = voume of the product in m For decorative cosmetics products the foowing appies: Σ(W packaging,i +W non-recyced,i ) 0,80 2* W product,tota W packaging,i = weight of the packaging unit i W non-recyced,i = weight of non-recyced materia in the packaging unit (if it is no recyced materia in the packaging W non-recyced = W packaging ) W product,tota = weight of fina product (packaging pus content) te: Mascara, eyeiner, eye primer, eyebrow iner, eye shadow, powder/rouge, conceaer, primer, shine, nai poish, ipstick, ip penci, ip goss and simiar products are considered decorative cosmetic products. ( Description of the packaging ( Weight of the primary packaging and product, and cacuation as specified above. (A spreadsheet for the cacuation is avaiabe from rdic Ecoabeing.) rdic Ecoabeing of Cosmetic products (25)

17 R28 Type of packaging It must be possibe to separate a materias in the packaging (paper, cardboard, pastic*, meta, gass) for sorting. Parts comprising mixed materias that cannot be separated are prohibited, with the exception of pump parts. This requirement does not appy to pressurized containers and packaging for decorative cosmetic products. *Pastic aminate is acceptabe. ( Specification of materias, incuding description of a components (cap, pump, id, etc.) R29 Pastic packaging Pastic packaging (incuding abes) containing PVC or pastic based on other types of haogenated materias must not be used. Primary packaging made from pastic shoud be marked according to the terms of the European Commission s decision of the 28th January 1997, 97/129/EC (EU, 1997), ISO 11469:2000, DIN 6120, part 2 or equivaent. Caps and pumps as we as packaging for decorative cosmetic products are exempt from the requirement on marking. ( Appendix 6 or equivaent decaration duy competed and signed. ( Adherence with the marking requirement wi be checked through packaging sampes/product sampes/images of the packaging/inspection visits. R30 Meta packaging Meta packaging may ony be used for spray bottes/aerosos for hair stying products and shaving foams. The use of sma parts made of meta, e.g. part of a hand pump or seaing foi, is permitted. Meta part may be used in packaging for decorative cosmetic products if the amount of meta does not exceed 15% of the tota packaging weight. Meta parts in decorative cosmetics may be used in the packaging if the tota weight of a meta parts in each separate product unit is ess or equivaent to 15 grams. Mirror is not aowed as part of the packaging. ( Packaging sampe/product sampe/images of the packaging/inspection visit. ( Decaration of meta content in packaging for decorative cosmetics. R31 Paper, cardboard and board packaging Packaging paper, cardboard or board must not be beached with chorine. ( Appendix 6 or equivaent decaration duy competed and signed. R32 Dispensing device The packaging sha be designed to faciitate optima dosage, e.g. through a correcty sized mouthpiece or a pump that suppies a suitaby sized dose. Regarding iquid soap, no pump or dispenser suppied or sod with the product sha dispense more than 2 g of soap per fu depression. In respect of hand soap for use in industry (for these products it shoud be ceary stated that the product is intended for washing severey soied hands in the context of industry, or simiar), no pump or dispenser suppied or sod together with the product is permitted to dispense more than 5 g of product per fu depression. ( Description of dispensing device and weighing resuts of iquid/industria soap per fu depression. rdic Ecoabeing of Cosmetic products (25)

18 3 Consumer information requirements R33 Decaration of contents A decaration of contents in accordance with the terms of Counci Directive 76/768/EEC on cosmetics and/or Reguation 1223/2009/EC on cosmetics must be found in the packaging. ( Labe or packaging sampe. Are the requirements met? R34 Information text The foowing products must bear the foowing or an equivaent information text on the abe: Do not discard cotton woo or paper carrying this product in the avatory or drain. Dispose of in a dustbin. Pictograms may be accepted: Ceaning products, e.g. ceansing otions and eye make-up remover. Nai poish removers Wet wipes The foowing products must bear the foowing or an equivaent information text on the abe: Do not discard out-of-date/unwanted product in the avatory, drain or dustbin. Pease eave at a coection point for hazardous waste: Nai poish Nai poish removers Contact rdic Ecoabeing for information texts appicabe for the country in question. ( Labe or packaging sampe. R35 Information test Sunscreen The recommended dosage of sunscreen must be stated and the sunscreen must bear the foowing or an equivaent information text on the abe: The most effective protection against the sun s rays is achieved by staying in the shade or wearing cothes. It is important to appy the recommended dose; otherwise you wi not achieve the expected eve of protection. Re-appy frequenty to maintain protection, especiay after perspiring, swimming or toweing. Contact rdic Ecoabeing for information texts appicabe for the country in question. The abeing of a sunscreen product with its SPF factor must foow the European Commission recommendations of 22 September 2006 (EU, 2006). The product must be abeed with the foowing decaration: Sun protection factor 6 and 10: Low protection Sun protection factor 15, 20 and 25: Medium protection Sun protection factor 30 and 50: High protection Sun protection factor 50+: Very high protection ( Labe or packaging sampe. rdic Ecoabeing of Cosmetic products (25)

19 R36 Product caims If the product is said to contain organic ingredients, the percentage of certified organic ingredients, in percent by weight, must be ceary stated. The system of certification must be indicated. This is information may be provided in the form of, for exampe, the foowing text: Content of organicay certified ingredients in the product: x % or with parentheses in the INCI ist. The precise content may be indicated, or, aternativey, the intervas in Tabe 4 may be used. These caims for the product may ony be made if proper documentation of the organic status of the ingredients can be suppied. Tabe 4 Actua content (%) Interva that may be used (%) < 0,1 <0, <1 1-5 < < < < < < < >75 ( Labe and certificates for the organic ingredients. rdic Ecoabeing of Cosmetic products (25)

20 4 Performance/quaity requirements R37 Performance/quaity The performance and quaity of the product must be satisfactory. This can be demonstrated by sending in documentation according to appendix 8. Tests must at a minimum test the characteristics with which the product is marketed, see appendix 8 for information regarding what the test report needs to contain to be adequate documentation of the performance/quaity. If there is a recognised test method (see for exampe R38 for sunscreen products), this sha be used. For other products, a test coud be the manufacturer s interna quaity test, a consumer test with test group of 10 or more independent individuas, or a comparative test reating to a simiar product, e.g. a triange test. The Coipa (Cosmetics Europe) guideines on Efficacy Evauation of Cosmetic Products can be observed. For other test reports the information in appendix 8 needs to be incuded. ( Description of the documentation according to appendix 8. If a consumer test is used a copy of competed and signed test reports is to be suppied. This report sha incude a description of the test group, the number of participants and a summary of test resuts. ( Appendix 3 or equivaent decaration duy competed and signed. Are the requirements met? Specia requirements in respect of sunscreen R38 Performance, UVA and UVB protection Satisfactory UVA and UVB protection sha be documented in accordance with Commission Recommendation of 22 September ( Description of the test and test resuts. Specia requirements in respect of toothpaste R39 Performance, fuoride Toothpaste sha contain fuoride in accordance with nationa recommendations for fuoride content. If the toothpaste is fuoride free or contains ess than the recommended eve, evidence must be presented that the efficacy of the toothpaste is equa to that of a fuoride toothpaste. This may be documented by scientific pubications, recommendations by experts (dentists) and in-vivo testing. ( Recipe or copy of pertinent pubications, recommendations and test resuts, as detaied above. rdic Ecoabeing of Cosmetic products (25)

21 5 Quaity and reguatory requirements Are the requirements met? To ensure that rdic Ecoabeing requirements are fufied, the foowing procedures must be impemented. If the cosmetics manufacturer s environmenta management system is certified to ISO or EMAS, where the foowing procedures are appied, it is sufficient if an auditor from an accredited body certifies that the requirements are impemented. R40 Laws and reguations The icensee must ensure that appicabe aws and reguations in force are observed at faciities at which the rdic Ecoabeed product is manufactured. For exampe, safety, work environment, environmenta egisation, pant-specific conditions and concessions. documentation is required, but rdic Ecoabeing may revoke the icence if the requirement is not fufied. R41 Licence administrators The company sha appoint an individua responsibe for ensuring the fufiment of rdic Ecoabe requirements, and a contact person for communications with rdic Ecoabeing. ( A chart of the company s organisationa structure detaiing who is responsibe for the above. R42 Documentation The icensee must be abe to present a copy of the appication and factua and cacuation data supporting the documents submitted on appication (incuding test reports, documents from suppiers and suchike). Checked on site. R43 Product quaity The icensee must guarantee that the quaity in the production of the rdic Ecoabeed cosmetic product is maintained throughout the vaidity period of the icence. ( Procedures for coating and, where necessary, deaing with caims and compaints regarding the quaity of the rdic Ecoabeed cosmetic product. R44 Panned changes Written notice must be given to rdic Ecoabeing of panned changes in products and markets that have a bearing on fufiment of rdic Ecoabe requirements. ( Procedures detaiing how panned changes in products and markets are handed. R45 Unpanned nonconformities Unpanned nonconformities that have a bearing on fufiment of the ecoabeing requirements must be reported to rdic Ecoabeing in writing and journaed. ( Procedures detaiing how unpanned nonconformities are handed. R46 Traceabiity The icensee must have a traceabiity system for the production of the rdic Ecoabeed cosmetic product. ( Description of/procedures for the fufiment of the requirement. rdic Ecoabeing of Cosmetic products (25)

22 6 Take-back system and marketing Are the requirements met? R47 Take-back system Reevant nationa reguations, egisation and/or agreements within the sector regarding the recycing systems for products and packaging sha be met in the rdic countries in which the rdic Ecoabeed cosmetic product is marketed. In Finand this may be documented with proof of membership of PYR (Environmenta Register of Packaging), in Sweden through REPA, and in rway documentation must be provided by Grønt Punkt. equivaent organisation currenty exists in Denmark. ( A decaration from the appicant in respect of adherence to existing recycing/take-back agreements, or other documentation demonstrating fufiment of the requirement, may aso be required. See Appendix 3. R48 Marketing The requirement is removed as decided by the Board of Directors 17 vember Marketing The rdic Ecoabe is a very we-known and we-reputed trademark in the rdic region. A rdic Ecoabeed cosmetic product may be marketed using the rdic Ecoabe so ong as the associated icence is vaid. The abe must be positioned so that there is no doubt as to what the abe refers and so that it is cear that it is the cosmetic product that is ecoabeed. More information on marketing can be found in Reguations for the rdic Ecoabeing of products of 22 June 2011 or ater version. Design of the rdic Ecoabe Design of the rdic Ecoabe: Licence number Each icence has a unique eight-digit icence number that must be dispayed aong with the abe. More information on the design of the abe can be found in Reguations for the rdic Ecoabeing of products of 22 June 2011 or ater version. rdic Ecoabeing of Cosmetic products (25)

23 Foow-up inspections rdic Ecoabeing may decide to check whether the cosmetic product fufis rdic Ecoabe requirements during the icence period. This may invove a site visit, random samping or simiar test. The icence may be revoked if it is evident that the rdic Ecoabeed cosmetic product does not meet the requirements. Random sampes may aso be taken from trade sources and anaysed by an independent aboratory. If the requirements are not met, rdic Ecoabeing may charge the anaysis costs to the icensee. How ong is a icence vaid? rdic Ecoabeing adopted the criteria for cosmetic products on 12 October These criteria remain vaid unti 31 December At the Secretariat Managers meeting on 16 February 2011 rdic Ecoabeing decided to change the requirements R6 Nanomaterias/-partices and R21 Cassification of enzymes. The new version is 2.1. At the Secretariat Managers meeting on 13 September 2011 rdic Ecoabeing decided on a change in requirement R7 Surfactants. The new version is caed 2.2. The rdic Ecoabeing Board on 15 December 2011 decided on changes on R25, R26, R27, R28, R29 and R30. The change in R25 was a re-phrasing of the documentation requirements making them more readabe. The change in R26 was to aow a rinse-off products for animas to be incuded in the product group. The changes in R27-R30 were adjustments to make it possibe for decorative cosmetic products to appy for an Ecoabe. Furthermore some corrections were made to appendix 3 and 4. The new version is 2.3. At the secretariat managers meeting on 10 May 2012 rdic Ecoabeing decided to change the requirements R12 Metas and R27 Quantity of packaging. The change of R12 means that it is not required any additiona documentation for coouring agents that meets the criteria for purity in food stuffs. The change of R27 meets the use of recyced materias in packaging materias to decorative cosmetics the same way as other products. The new version is 2.4. On 12 December 2012 the rdic Ecoabeing Board adopted a change in R3. The new version is 2.5. At the secretariat managers meeting on 8 February 2013 rdic Ecoabeing decided to change the requirement R4 SCCS Opinions. The change of R4 means that SCCS Opinion is exempted the requirement with exception of certain specific substances. The new version is 2.6. At the secretariat managers meeting on 25 September 2013, rdic Ecoabeing decided to change requirement R37 regarding the performance test to make it possibe to document tests without foowing the Coipa guideines (Cosmetics Europe). To ensure that reports not foowing Cosmetics Europe s guideines are of good quaity a new appendix has been added to give information regarding reports (appendix 8). The critera was aso proonged with 18 months and the new version is caed 2.7 and is vaid unti 30 June rdic Ecoabeing of Cosmetic products (25)

24 The rdic Ecoabeing board decided on 11 December 2013, that micropastics shoud be added to the ist prohibited substances in the products in requirement 5 (R5). The new version is caed 2.8. At the secretariat managers meeting on 19 February 2014 rdic Ecoabeing decided to change R14 to make it cearer that no fragrance substances can be added to infant, baby and chid products. At the same time appendix 8 was updated with information on how the producer can verify caims such as mid. The new version is caed 2.9. rdic Ecoabeing s Criteria Group decided on 14 Apri 2015 to proong the criteria with 12 months. On 17 vember 2014 the Board of Directors decided to remove requirement R48 Marketing. The new version is caed 2.10 and is vaid unti 30 June An editoria change was made on 4 June 2015 in R6 Nanomaterias/-partices. An ecoabe icence is vaid providing the criteria are fufied and unti the criteria expire. The vaidity period of the criteria may be extended or adjusted, in which case the icence is automaticay extended and the icensee informed. Revised criteria sha be pubished at east one year prior to the expiry of the present criteria. The icensee is then offered the opportunity to renew their icence. If a ist or document to which these criteria refer (SCCS opinions under R4 and R24 and endocrine disrupters under R5) are changed during the vaidity period of a icence, a standard transition period of three months is aowed from the pubication of the new ist/document in which to make the changes/reformuation necessary for the product to meet the modified requirements. rdic Ecoabeing may decide to adjust the ength of this transition period, and wi in such a case inform icensees and appicants. It shoud be noted that the icence hoder is aways responsibe for ensuring that the product is in compiance with the terms of the requirements. New criteria The foowing areas wi, among others, be evauated in future criteria: Possibiity to set obigatory requirements in respect of sustainabiity and sourcing of raw materias from renewabe sources certified raw materias and certified organic raw materias Limits on degradabe substances and CDV, as we as a separating of the requirements in respect of degradabiity and toxicity. Packaging/Meta packaging requirements. rdic Ecoabeing of Cosmetic products (25)