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Nordic Ecolabelling Version 3.3 18 March 2004 – 31 March 2011 Nordic Ecolabelling of Shampoo, conditioner, body shampoo, liquid and solid soap

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Page 1: Nordic Ecolabelling of Shampoo, conditioner, body shampoo ... · Swan labelling of Shampoo, conditioner, body shampoo, liquid and solid soap 3.3 p4 How to apply Applications must

Nordic Ecolabelling

Version 3.3 • 18 March 2004 – 31 March 2011

Nordic Ecolabelling of

Shampoo, conditioner, body shampoo, liquid and solid soap

Page 2: Nordic Ecolabelling of Shampoo, conditioner, body shampoo ... · Swan labelling of Shampoo, conditioner, body shampoo, liquid and solid soap 3.3 p4 How to apply Applications must

AddressesIn 1989, the Nordic Council of Ministers decided to introduce a voluntary official ecolabel, the Swan. These organisations/companies operate the Swan ecolabelling system on behalf of their own country’s government. For more information, see the websites.

This document may only be copied in its entirety and without any kind of alteration. It may be quoted from provided that Nordic Ecolabelling is stated as the source.

This document may only be copied in its entirety and without any kind of alterations. It may be quoted from provided that Nordic Ecolabelling is stated as the source.

Content

What is Swan labelled shampoo and soap? 3

Why choose the Swan label? 3

Which products can be Swan labelled? 3

How to apply 4

Documentation 4

1 Ecolabelling requirements 5 1.1 General requirements (applies to all products, including products for animals) 5 1.2 Specific requiremements regarding products for animals 12 1.3 Requirements as to waste processing and recycling systems 12 1.4 Requirements as to packaging 13 2 Requirement as to effeciency 14

3 Other requirements 14 3.1 Authority requirements 14 3.2 Eco and quality assurance 15 3.3 Marketing 15 4 Analysis and control 16 4.1 Sampling/analysis laboratory 16 4.2 Follow-up inspections 17

Registration 18

The design of the ecolabel 18

The validity of the criteria document 18

Future criteria 19

References 19

Appendix 1: Marketing of ecolabelled productsAppendix 2: DeclarationAppendix 3: Example of calculationsAppendix 4: Substances causing endocrine disruption in accordance with the EU listAppendix 5: Fragrance substances that are limited in useAppendix 6: Framework conditions for testing efficiency

This is a translation of the criteria document in Danish. In any case of dispute, the original document should be taken as authoritative.

027 Shampoo, conditioner, body shampoo, liquid and solid soap, version 3.3, 3 December 2008

DenmarkEcolabelling DenmarkDanish StandardsKollegievej 6DK-2920 CharlottenlundTelefon +45 72 300 450Fax +45 72 300 451E-post: [email protected]

SwedenSIS EcolabellingSE-118 80 StockholmTelefon +46 8 55 55 24 00Fax +46 8 55 55 24 01E-post: [email protected]

NorwayEcolabelling NorwayTordenskiolds gate 6 BNO-0160 OsloTelefon +47 24 14 46 00Fax +47 24 14 46 01E-post: [email protected]

FinlandSFS EcolabellingBox 116FI-00241 HelsingforsTelefon +358 9 149 9331Fax +358 9 149 93320E-post: [email protected]

IcelandEcolabelling IcelandUmhverfisstofnunSuðurlandsbraut 24IS-108 ReykjavikTelefon +354 591 20 00Fax +354 591 20 20www.svanurinn.is

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Swan labelling of Shampoo, conditioner, body shampoo, liquid and solid soap 3.3 p3

What is Swan labelled shampoo and soap?

Swan labelled shampoo and soap belong to the least environmentally hazard-ous products within their category. Requirements are imposed on the classifi-cation of substances used, on degradability and bioaccumulability, on the use of fragrances and colouring agents, on packaging and also on the efficiency of the products.

The products are discharged to water after use. Accordingly, properties such as biological degradability, bioaccumulation and toxicity in aquatic environments are key considerations as regards all constituent components. This applies in particular to surfactants, which are the most important constituents of the products in terms of quantity and function.

Shampoo and soap come into direct contact with the skin. Accordingly, their content of skin irritants, allergens or other harmful components and pollut-ants should be as low as possible.

Why choose the Swan label?

The products may use the Swan trademark in their marketing. The Swan label enjoys considerable renown and confidence in the Nordic Countries.

The Swan label is a cost-effective and simple way of communicating envi-ronmental work and devotion to purchasers and consumers.

Environmental questions are complex and it can take long time to gain know ledge about specific environmental subjects. Swan labelling can be seen as a tool to do this.

Swan labelling is not only about environmental issues but also about quality because these two parameters cannot be separated. This means that a licence to the Swan label is also a quality stamp.

Which products can be Swan labelled?

Liquid and solid cosmetic products (see the EU Cosmetics Directive 76/768/EEC with adaptations) used primarily for cleaning and washing the skin and hair of the body and which are removed with water after use, qualify for a Swan label.

Liquid and solid products for conditioning hair and removed with water after use are also included.

Products for use on animals for the same purpose also qualify for a Swan label, although products for removing vermin (e.g. anti-flea products) are not encompassed by the criteria.

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Swan labelling of Shampoo, conditioner, body shampoo, liquid and solid soap 3.3 p4

How to apply

Applications must follow ”Rules on the Nordic Ecolabelling of products” and the ecolabelling requirements in this document.

Each requirement is marked with the letter R (for requirement) and a number. The applicant must submit the documentation specified (with the symbol () under each individual requirement in Chapters 1, 2 and 3. The application must also contain a list of contents specifying the documentation supplied in support of each requirement.

Guidelines on how the application should be structured and a spreadsheet for use in calculating the chemical requirements specified in the criteria document are available from Nordic Ecolabelling (the addresses can be found on page 2).

For a product to be awarded a Swan label, all requirements in this document must be fulfilled.

Documentation

Documentation archived by the applicant/licence holder

The licence holder must file the following documentation during the licence period and must present it upon request by the ecolabelling organization in the event of a follow-up inspection at the applicant’s place of business and in connection with the processing of the application:

A copy of the application in its entirety.

The facts/calculation basis underlying the documentation submitted in connection with the processing of the application.

The results of checks performed in connection with the production of the ecolabelled products.

Journals showing planned production changes and unforeseen deviations in the production process.

All complaints and claims in connection with the ecolabelled products.

Documentation for chemicals

For documentation where references are made to Nordic Ecolabelling’s Chemical List, information from Nordic Ecolabelling’s current Chemical List (see chapter 4.1.6) must be used. For substances that are not encompassed by Nordic Ecolabelling’s Chemical List, documentation can take the form of e.g. copies of test reports or literature references.

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Swan labelling of Shampoo, conditioner, body shampoo, liquid and solid soap 3.3 p5

1 Ecolabelling requirements

1.1 General requirements (applies to all products, including products for animals)

Testing of the product

R1 Animal testing The final product must not be tested on animals within 5 years from the

time of application. Products for use on animals can however be tested with regard to efficiency on the ani-

mal for which the use is intented.

( A completed and signed declaration (Appendix 2).

Active Content (AC)

R2 Calculation of active content The active content (AC) must be calculated on the basis of the complete

formulation of the product.

Appendix 3 provides an example of a calculation.

For the purpose of this document AC means the quantity (in weight) of all organic sub-stances present in the product, excluding the water content of the components. Rubbing/abrasive agents in hand cleaning agents are not included.

( Technical description of the contents of the product (complete formulation), including known pollutants. The description must include a specification of quantities, CAS No. and INCI designations.

A specification of the function of each individual ingredient in the product, stating the purpose for which the component is added.

Safety data sheet/Product data sheet with the name of the supplier of all ingredients.

Specification of the number as shown in Nordic Ecolabelling’s current Chemical List (cf. 4.1.6) for all ingredients/substances encompassed by the list.

Specification of the water content of all ingredients.

Calculation of grams AC per gram of product.

Are the require-ments met?

Yes No

Appendix No _____

Yes No

Appendix No _____

Appendix No _____

Appendix No _____

Appendix No _____

Appendix No _____

Appendix No _____

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Requirements as to constituent substances and degradation products

The following requirements apply to all constituent substances in all types of products. Special requirements for products intended for animals can be found in Chapter 1.2.

R3 Classification of constituent substances No constituent substance must be classified as carcinogenic (Carc), muta-

genic (Mut) or toxic to reproduction (Rep) including rules for self-classifica-tion. No constituent substance must be classified as sensitising Xi with R42 and/or R43 including rules for self-classification. See also the special rules applicable to fragrances in R15-R18 and R25.

( Product safety datasheets complying with the applicable legislation gov-erning all constituent substances showing the classification of the ingredi-ent in question.

A completed and signed declaration (Appendix 2).

R4 The EU list of substances that cause endocrine disruption No constituent substance must be on the EU list of substances that cause

endocrine disruption class 1 or 2, see Appendix 4.

( A completed and signed declaration (Appendix 2).

Surfactants

R5 Degradability of the surfactants All surfactants must be readily biodegradable in accordance with the

requirements contained in section 4.1.1 and anaerobically biodegradable in accordance with the requirements contained in section 4.1.3.

( Documentation, with references to Nordic Ecolabelling’s Chemical List, that the requirement has been fulfilled must be submitted for each individual surfactant.

R6 LAS, APEO and APD Linear alkylsulphonates (LAS), alkylphenol ethoxylates (APEO) and alkylphe-

nol derivates (APD) must not be added to the product.

( A completed and signed declaration (Appendix 2).

Are the require-ments met?

Yes No

Appendix No _____

Yes No

Yes No

Yes No

Appendix No _____

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Degradability

R7 Aerobic non-biodegradable organics (aNBDO) The content of organic substances (surfactants are extempted) that are not

readily biodegradable (in accordance with section 4.1.1) must not exceed the limits stated below.

The limits also apply for products for animals.

Organic rubbing/abrasive agents in hand cleaning agents shall not be counted.

Shampoo, body shampoo, liquid soap: 15 mg/g AC

Solid soap: 10 mg/g AC

Conditioner: 30 mg/g AC

( Documentation, with references to Nordic Ecolabelling’s Chemical List, showing that the requirement has been fulfilled must be submitted as to the readiness of biodegradability.

In the absence of documentation, the substances will be viewed as non-readily biode-gradable.

Calculation of the quantity (mg) of aNBDO per gram AC.

R8 Anaerobic non-biodegradable organics (anNBDO) The content of organic substances (surfactants are extempted) that are not

anaerobically biodegradable (anNBDO) must not exceed the limits stated below.

The limits also apply for products for animals.

Organic rubbing/abrasive agents in hand cleaning agents are not counted in.

Shampoo, body shampoo, liquid soap: 15 mg/g AC

Solid soap: 10 mg/g AC

Conditioner: 30 mg/g AC

All substances that are not anaerobically biodegradable (in accordance with the require-ments in section 4.1.3) will be viewed as anNBDO. In the absence of documentation the substances will be viewed as anNBDO unless they are readily anaerobically biodegrad-able and at the same time either

have low adsorption (A<25%) or high desorption (D>75%) in accordance with OECD Guideline No. 106, or

are not bioaccumulable in accordance with the requirements in section 4.1.5.

( Documentation provided for above, with references to Nordic Ecolabelling’s Chemical List, showing that the requirement has been fulfilled.

In the absence of documentation the substances will be viewed as anNBDO

Calculation of the quantity (mg) of anNBDO per gram AC.

Are the require-ments met?

Yes No

Appendix No _____

Yes No

Appendix No _____

Appendix No _____

Appendix No _____

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Preservatives

R9 The Cosmetic Directive Preservatives must be approved according to the Cosmetic Directive

Annex VI.

( Specification of the preservatives used in the product and raw materials/ingredients.

R10 Use of preservatives The use of preservatives for purposes other than preservation is not allowed.

( A completed and signed declaration (Appendix 2).

R11 Bioaccumulation of preservatives Preservatives used in the product or its raw materials/ingredients must not

be bioaccumulable in accordance with the requirements in section 4.1.5.

( For each individual preservative, documentation with references to Nordic Ecolabelling’s Chemical List, showing that the requirements have been ful-filled must be submitted.

R12 Release of substances Preservatives must not release substances that are classifiable in accordance

with R3 and R4.

( See R10.

Complexing agents

R13 NTA Nitrilotriacetate (NTA, CAS-no. 139-13-9) must not be present in the product.

( A completed and signed declaration (Appendix 2).

R14 EDTA and phosphonates Ethylene diamine tetra acetate (EDTA) and salts hereof (e.g. CAS-no. 64-

02-8) and phosphonates may be present only in solid soap, and the total quantity must not exceed 0.6 mg/g AC.

( A completed and signed declaration (Appendix 2).

Calculation of the quantity (mg) of EDTA and phosphonates per gram of AC.

Fragrance

R15 IFRA Fragrances used must comply with the International Fragrance Association’s

(IFRA) guidelines as described in ”Code of Practice”. IFRA Guidelines can be found on www.ifraorg.org/guidelines.asp

( Confirmation from the fragrance manufacturer that IFRA’s guidelines have been followed (with statement of which concentration the fragrance can be used in the product, if such concentration emerges from the IFRA’s guide-lines).

Are the require-ments met?

Yes No

Appendix No _____

Yes No

Yes No

Appendix No _____

Yes No

Yes No

Yes No

Appendix No _____

Yes No

Appendix No _____

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R16 Fragrances in products for babies/infants Fragrance must not be added to products that are sold for use on babies/

infants.

( Label.

R17 Musk xylene and Musk keton Musk xylene (CAS-no. 81-15-2) and Musk keton (CAS-no. 81-14-1) must

not be present in the product.

( A completed and signed declaration (Appendix 2).

R18 Quantities of fragrance substances Fragrance substances classified R43 or frangrances substances specified

in Appendix 5 may be present in the product in quantities not exceeding 0.01% (100 ppm).

Fragrances substances classified with R43 or found in Appendix 5 may be part of the fragrance mix in amounts below 1% if the total amount of sub-stances classificed R43 or found in Appendix 5 do not exceed 5% of the fragrance mix.

( A completed and signed declaration (Appendix 2).

An account for the content of fragrances mentioned in appendix 5 in the product.

Colouring agents

R19 The Cosmetic Directive Colouring agents must be approved according to the Cosmetic Directive

Annex IV.

( A list of colouring agents used with their CI numbers or alternatively E numbers.

A completed and signed declaration (Appendix 2).

R20 Organic colouring agents Organic colouring agents must not be bioaccumulable in accordance with

chapter 4.1.5. In the case of colouring agents approved for use in foodstuffs it is not necessary to submit

documentation of non-bioaccumulability.

( Documentation, with references to Nordic Ecolabelling’s Chemical List, of compliance with the requirement must be submitted for each individual col-ouring agent.

pH regulators

R21 pH regulators Boric acid, borates and perborates must not be present in the product.

( A completed and signed declaration (Appendix 2).

Yes No

Are the require-ments met?

Appendix No _____

Yes No

Yes No

Appendix No _____

Yes No

Appendix No _____

Yes No

Appendix No _____

Yes No

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Enzymes

R22 Enzymes Enzymes are exempted from requirement as to classification with R42.

Enzymes must be a dust-free granulate or liquid.( Statement from the enzyme producer or information on safety data sheet.

Toxicity and degradablility

R23 Calculation of toxicity and degradablility points (TD)/ Critical Dilution Volume (CDV

(acute))

The total score for toxicity and degradability (TD) or the critical dilution vol-ume (CDV

(acute)) must not exceed the maximum values specified below:

Product type TD CDV(acute)

Shampoo, body shampoo, liquid soap: 350 l/g A 17,500 l/g AC

Solid soap: 85 l/g AC 6,000 l/g AC

Conditioner: 600 l/g AC 20,000 l/g AC

The limits above also apply to products for animals. The calculation of toxic-ity and degradability points (TD) and critical dilution volume (CDV

(acute)) are

based on information on the toxicity and degradability of the individual substances in an aquatic environment. TD and CDV

(acute) are both expressed

as litre/g AC and are calculated for each individual substance using the fol-lowing formulas:

TD = DF x Quantity (mg) of the substance per g AC x SF

ToxI

CDV(acute)

= DF x Quantity (mg) of the substance per g AC / TF(acute)

Information on DF (degradation factor), SF (safety factor) and ToxI (toxicity index) as a general rule must be taken from Nordic Ecolabelling’s current Chemical List. DF (degradation factor from the DID-list) and TF

(acute) (acute

toxicity factor) as a general rule must be taken from the DID-list dated January 2007 or later versions. In the case of substances not included on the lists, these factors are determined in the following way:

DF is set at: 1 in the case of organic substances that are readily biodegradable in

accordance with section 4.1.1. 5 in the case of organic substances that are potentially (ultimately)

biodegradable in accordance with the requirements in 4.1.2. 10 in the case of other substances (organic and inorganic).

ToxI is determined on the basis of the requirements in section 4.1.4.

SF is determined by the number of groups of organisms (fish, daphnia, algae) for which toxicity data is available. SF is set at:

1 in the case of substances for which toxicity data is available for all three groups of organisms.

5 in the case of substances for which toxicity date is available for two groups of organisms.

10 in the case of substances for which toxicity data is for only a single group of organisms.

If scientific documentation is available that shows to a reasonable degree of certainty that the most sensitive organism has been tested, the safety factor may be set at 1, even though toxicity data is not available for all three groups of organisms.

Are the require-ments met?

Yes No

Swan labelling of Schampoo, conditioner, body schampoo, liquid and solid soap 2.0 p10

Yes No

Appendix No _____

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DF is determined as described below (see the DID-list part B for details): 0.05 for organic substances that are easily degradable according to the

requirements in section 4.1.1. 0.15 for organic substances that are easily degradable according to the

requirements in section 4.1.1 but that do not fulfil the 10-day win-dow (surfactants exempted).

0.5 for organic substances that are inherently degradable according to the requirements in section 4.1.2.

1.0 for organic substances that are persistent

TF(acute)

is determined as described below (see the DID-list part B for details):

TF(acute)

= toxicity / SF(acute)

,

Where toxicity is the lowest acute LC50/EC

50/IC

50-value and SF(acute) is

determined as described in the following.

SF(acute)

is determined as described below (se the DID-list part B for details): 1,000 for substances for which acute toxicity data is found for all three

groups of organisms. 5,000 for substances for which acute toxicity data is found for two groups

of organisms. 10,000 for substances for acute toxicity data is found for one group of

organism. The toxicity and degradability points/critical dilution volume for all constitu-

ent substances are then added up. An example of a calculation of TD is provided in Appendix 3.

( For each individual substance data must be submitted on degradability and toxicity in accordance with the requirements contained in sections 4.1.1, 4.1.2 and 4.1.4. The documentation as a general rule should be a reference to Nordic Ecolabelling’s current Chemical List.

Calculation of TD or CDV(acute)

for all constituent substances and the total product (the total of the TD/CDV

(acute) of the substances).

Appendix No _____

Appendix No _____

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1.2 Specific requiremements regarding products for animals

R24 Classification of the product Products for animals must not be classified as environmentally harmful,

highly toxic (Tx), toxic (T), corrosive (C), harmful to health (Xn), irritant (Xi), carcinogenic (Carc), mutagenic (Mut) or toxic to reproduction (Rep).

Classification in accordance with the Dangerous Substances Directive 67/548/EEC and 1999/45/EC with adaptations or in accordance with the specific rules and substance lists applicable in the individual Nordic country.

( Product safety data sheets providing an account of the classification of the product.

If no product safety data sheets are available, some other account in accordance with Directive 67/548/EEC and/or 1999/45/EC with adaptions must be presented.

R25 Fragrances in products for animals Fragrances must not be present in products for animals.

( A completed and signed declaration (Appendix 2).

R26 Colouring agents Colouring agents must not be present in products for animals.

( See R25.

1.3 Requirements as to waste processing and recycling systems

R27 Recycling systems for products and packaging The relevant national regulations, laws and/or industry agreements on

recycling systems for products and packaging must be fulfilled in the Nordic countries in which the ecolabelled products are marketed.

( Declaration from the applicant confirming existing agreements on recycling/return systems.

Are the require-ments met?

Yes No

Appendix No _____

Yes No

Yes No

Yes No

Appendix No _____

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1.4 Requirements as to packaging

R28 Specification of packaging The packagingof the product shall be specified in terms of materials and

weight.

( Specification of the packaging.

R29 Calculation of the weight/content ration of the product (WCR) The weight/content ratio of the packaging used on the product must be

less than the limit specified below:

WCR < 0.30 g/g (*) (*) in the case of products where the packaging is designed to be inserted directly into a

dispensing system the weight/content ratio must be less than 0.40 g/g.

The weight/content ratio is defined as the weight of the packaging around the product plus the weight of the packaging that is not reused as a pro-portion of the weight of the product multiplied by the number of times the packaging around the product is used (once, except in the case of refill sys-tems). This can also be expressed in the following way:

WCR = ∑ ((Wi + Ni) / (Di x r)) where:

Wi = The weight (in grams) of the packaging component i (primary, group or transport packaging) including the label where applicable.

Ni = The weight (in grams) of non-recycled material in the packaging component i (primary, group or transport packaging). If the propor-tion of recycled material in the packaging component is 0%, then Ni = Wi.

Packaging material is regarded as recycled if its raw materials have been col-lected from the packaging manufacturer or the distribution or consumer stages. Raw material comprising industrial waste from the material manufacturers own production is not regarded as recycled.

Di = Grams of product packaged by the packaging component i.

r = The number of recyclings, i.e. the number of times the packaging component i is used for the same purpose in a recycling or refill sys-tem (r=1 if the packaging is not reused for the same purpose).

If the packaging is reused for the same purpose several times, the value for r will be 20 in the case of plastic and 10 in the case of cardboard, unless the applicant can document a higher frequency of recycling.

An example of a calculation is provided in Appendix 3.

( Control weighing of primary packaging.

Calculation of WCR.

R30 Chlorinated materials Packaging (including labels) that contains PVC or plastics based on other

types of chlorinated materials are not allowed.

( A completed and signed declaration (Appendix 2).

Are the require-ments met?

Yes No

Appendix No _____

Yes No

Appendix No _____

Appendix No _____

Yes No

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R31 Labelling of packaging To allow for identification of different parts of the packaging for recycling,

plastic parts in the primary packaging must be marked in accordance with DIN 6120, Part 2 or the equivalent.

Caps and pumps are excepted this requirement.

( Completed and signed declaration (Appendix 2).

Sample of packaging.

R32 Dosage The packaging must be designed to make correct dosage easy, e.g. by

ensuring that the opening at the top is not too wide.

( Description of the dosage device.

2 Requirement as to effeciency

R33 Efficiency The products must demonstrate a satisfactory degree of efficiency when

compared with existing products on the market.

( Consumer test or another form of test documenting satisfactory efficiency (conclusion, description of test method and test results). If applicable, the documentation of this point may be formulated as suggested in Appendix 6.

3 Other requirements

3.1 Authority requirements

R34 Authority requirements for working security, health and environment

The manufacturer of the product must comply with legislation, including provisions governing the working environment, external environment and permits granted by the authorities, in the country in which the product is manufactured.

( A signed application form.

Yes No

Are the require-ments met?

Yes No

Appendix No _____

Appendix No _____

Yes No

Appendix No _____

Yes No

Appendix No _____

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3.2 Eco and quality assurance

R35 Eco and quality assurance Producers of ecolabelled products or their dealers/importers must have

documented procedures and instructions in place to secure the following: that the requirements of the ecolabelling criteria are fulfilled; that the requirements are verifiable during the period of validity of the

licence; that the quality level of the performance and efficiency of the products

encompassed by the licence is maintained; that an organizational structure exists that is capable of guaranteeing that

the requirements of the ecolabelling criteria are fulfilled; that responsibility for maintaining contact with the ecolabelling organiza-

tion is allotted to a contact person.

( A description must be provided of the way in which the ecolabelling requirements are followed up, documented and reported in day-to-day production, i.e.:

a) the organization, person responsible for quality, contact person and other persons with responsibility in this area and their areas of responsi-bility;

b) monitoring and journal recording procedures; c) internal procedures for processing and reporting unforeseen deviations

from the ecolabelling requirements; d) internal procedures for documenting and reporting planned changes in

the production of the ecolabelled product; e) the procedures followed by the contact person when reporting points c)

and d) above to the ecolabelling organization (external procedures for reporting to the ecolabelling organization);

f) procedures for documenting, reporting and processing complaints/claims relating to the ecolabelled products;

g) procedures for securing the traceability of the ecolabelled products in the production system.

The licence holder must secure the written approval of the ecolabelling organization before making any changes that might have a bearing on whether or not the requirements of the criteria document are fulfilled.

3.3 MarketingR36 Marketing Marketing of ecolabelled products must proceed in accordance with the

”Regulations for Nordic Ecolabelling of Products”.

( Completed and signed declaration (Appendix 1).

Are the require-ments met?

Yes No

Appendix No _____

Yes No

Appendix No _____

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4 Analysis and control

4.1 Sampling/analysis laboratory

Sampling must be conducted in a qualified way. The laboratory performing the sampling/analyses must be impartial and competent. Raw data must be avail-able for checking by the ecolabelling organization during the period of validity of the licence.

The laboratory conducting the sampling/analyses must fulfil the general require-ments contained in the EN 45001/DS/EN/ISO/IEC 17025 standard or be an official GLP approved analysis laboratory. The applicant is liable for the cost of documentation and analyses.

The manufacturer’s sampling/analysis laboratory may be approved for the performance of analyses and tests if the manufacturer has a quality system in place that encompasses sampling and analysis.

4.1.1 Readily biodegradability, aerobic

In testing readily biodegradability, test method No. 301 (A to F) in OECD Guidelines for the Testing of Chemicals (ISBN 92-64-1222144) or other equivalent test methods should be used.

4.1.2 Potentially (ultimately) biodegradability, aerobic

In testing potential (ultimately) biodegradability, test method No. 302 (A to C) in OECD Guidelines for the Testing of Chemicals or other equivalent test meth-ods should be used.

4.1.3 Biodegradability, anaerobic

For testing anaerobic biodegradability, ISO 11734, ECOTOC No. 28 (June 1988) or equivalent test methods should be used. The requirement is a mini-mum of 60% degradability under anaerobic conditions.

4.1.4 Acute aquatic toxicity

For testing acute aquatic toxicity, test method No. 201, 202 or 203 in OECD Guidelines for Testing of Chemicals (ISBN 92-64-1222144) or other equiva-lent test methods should be used.

For surfactants, toxicity data on at least two groups of organisms is required (fish, daphnia, algae). In the case of other substances the toxicity data on a single species may be accepted. The ToxI (toxicity index) as a general rule must be taken from Nordic Ecolabelling’s current Chemical List (cf. 4.1.6). In the case of substances not included on the list ToxI is determined as the low-est LC50/EC50/IC50 (mg/litres). The ToxI must not be set higher than 300 mg/litres.

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4.1.5 Bioaccumulation

Unless the contrary is proved substances will be viewed as bioaccumulable if logPow ≥ 3 in accordance with OECD test guidelines 107 or 117 or equiva-lent. The bioaccumulability of a substance of this type may be tested on fish in accordance with OECD test guideline 305 A-E. If the biological concentra-tion factor (BCF) is ≥ 100 the substance will be regarded as bioaccumulable and if BCF < 100 the substance will be regarded as non-bioaccumulable.Note that the OECD guidelines state a higher BCF value, but Nordic Ecolabelling has chosen to fol-low the recommendations in EU, se the section in its entirety.

Information on logPow as a general rule must be taken from Nordic Ecolabelling’s current Chemical List (cf. 4.1.6).

OECD test instruction 107 is not applicable to surfactants capable to dissolve in both grease and water. For such substances, evidence must be presented that demonstrates to a high degree of certainty based on current knowledge that the substances or their degradation products do not represent a long-term or delayed hazard to the organisms in the aquatic environment.

4.1.6 The Chemical List

Nordic Ecolabelling’s Chemical List is available from the ecolabelling body. For these criteria, version 2.4 approved 10 June 2002 or later versions comply.

4.2 Follow-up inspections

Products for which an ecolabelling licence has been awarded may be subject to follow-up inspections as determined by the ecolabelling organization. A check of this type might be performed in many various ways. For example, a sample might be taken for analyses in the form of a random sample from products on sale through retail outlets, after which the sample will be analysed by an impartial test body. In cases such as this the licence holder will bear the cost of checking if the products do not comply with the information upon which the ecolabelling licence was posed.

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Registration

The following information must be documented by the applicant and will be checked by the ecolabelling organization in connection with the registration of the licence in other participating Nordic countries:

application form for registration,

copy of the licence;

copy of the label or packaging;

confirmation that the content and packaging are identical to the information submitted when the licence was awarded;

confirmation of membership (where applicable) of a recycling scheme.

The design of the ecolabel

See ”Regulations for Nordic Ecolabelling of products” for further details on the design of the Swan label. The Swan label and the allotted licence number (shown as 000-000) must have the following design

The ecolabel shall be affixed to the packaging and/or product.

The validity of the criteria document

This criteria document was adopted by the Nordic Ecolabelling Board on 18 March 2004 and will remain in force up to and including 2 May 2008.

During the period of validity the Nordic Ecolabelling Board may decide on adjustments, clarifications and/or extensions of the criteria, in which case a new version is issued. This normally entails no reappraisal of licences granted.

The Nordic Ecolabelling Board adopted on 15 December 2004 a change in the perfume requirements. The change affects R18. The new criteria version is called 3.1.

The Nordic Ecolabelling Board adopted on 14 March 2007 an addition to the requirements documenting the over-all environmental performance of the product expressed as critical dilution volume (CDV(acute)). This addition is found in R23. At the same time the criteria were prolonged by 2 years making

000 000

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them expire 31 March 2010. This resulted in criteria version 3.2 which is valid until 31 March 2010.

The Secretariat manager’s meeting on 3 December 2008 decided to prolong the validity of the criteria with one year. The new version is called 3.3 and is valid until 31 March 2011.

Nordic Ecolabelling will give notice of the future criteria at least 12 months before the expiry date of the current criteria document.

Future criteria

Future criteria will consider the following:

The need for plastic packaging to be labelled

Requirements on non-bioaccumulation in more groups of ingredients

Requirements relating to requirements on Cosmetic products

The stringency of the requirements in light of new knowledge (e.g. degra-dablility of colourants)

A review of requirements as to fragrances especially in relation to presence in products for children and a prohibition of the fragrances in appendix 5

Information on production date on the product

References

The Cosmetic Directive, 76/768/EEC with adaptations

The Dangerous Substances Directive 67/548/EEC and 1999/45/EC with adaptations

EU’s List of Endocrine Disrupters, Towards Establisment of a priority list of substances for further evaluation of their role in endocrine disruption, appen-dix 13 M0355008/1786Q/10/11/00, European Commission DG ENV, BKH Consulting Engineers, Delft, The Netherlands

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Appendix1 – Marketing of ecolabelled products

This is to certify that we are familiar with the regulations for the use of the Nordic Ecolabel as described in “Regulations for Nordic Ecolabelling of products.”

We hereby agree to undertake all marketing work in accordance with these regulations.

This is also to certify that we are familiar with the criteria document for Shampoo, conditioner, body shampoo, liquid and solid soap, including prod-ucts for animals.

We undertake to ensure that the persons marketing the ecolabelled products within our company will receive information on the criteria governing the ecolabelling of for Shampoo, conditioner, body shampoo, liquid and solid soap and “Regulations for Nordic Ecolabelling of Products”.

Date Company

Contact person Telephone

Head of marketing Telephone

In the event of a change of personnel, a new confirmation must be submit-ted to Nordic Ecolabelling..

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Appendix 2 – Declaration

For use in connection with an application for the ecolabelling of sham-poo, conditioner, body shampoo, liquid and solid soap and products for animals.

Name of the product: ___________________________________________

Product type:

□ Shampoo □ Conditioner □ Body shampoo □ Liquid soap □ Solid soap □ Product for animals □ Hand cleaning agent

Is the product tested on animals within 5 years?

Does the product contain substances that are endocrine disruptive sensitising, carci-nogenic, mutagenic or damaging to the reproductive system?

Does the product contain LAS, APEO or APD?

Have preservatives been approved in accordance with Annex VI to the Cosmetic Directive?

Are preservatives added solely for purposes of preservation?

Does preservatives release substances classified in accordance with R3 or R4?

Does the product contain NTA?

Does the product contain EDTA and/or phosphonates?

Does the product contain fragrances?

Does the product contain musk xylene or musk keton?

Does the product contain fragrances stated in appendix 5?

Does the product contain colouring agents?

Have colouring agents been approved in accordance with Annex IV to the Cosmetic Directive?

Does the product contain boric acid, borates or perborates?

Does the packaging (including labels) contain PVC or plastics based on other types of chlorinated materials?

Are all plastic parts marked in accordance with DIN 6120, Part 2 or the equivalent (capsuls and pumps execpted)?

Date: Company name:

Signatory

Repeated in block capitals

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

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Appendix 3 – Example of calculations

The sole purpose of the following example is to enable applicants to check that they have understood the calculation rules contained in the criteria cor-rectly.

The following shows the recipe for a fictitious product, the quantity of indivi-dual ingredients as a percentage, calculation of AC, the numbers of the ingre-dients in the Chemical List (cf. 4.1.6) and the calculation of TD.

Composition % AC in %

g/g AC

CL No.

ToxI SF DF TD

Ammonium Lauryl Sulphate (30%) 21 6.3 0.414 6 5 1 1 82.9

Sodium Lauryl Ether Sulphate (27%) 18 4.9 0.322 7 2.5 1 1 128.9

Cocamidopropyl Betaine (30%) 1 0.3 0.020 51 2.5 1 1 7.9

Propylene Glycol 2.5 2.5 0.164 152 300 1 1 0.5

Sorbic Acid 0.02 0.02 0.001 lit. ref* 300 10 1 0.0

Sodium Chloride 0.5 Inorg. 0.033 123 1,000 1 10 0.3

Fragrance 0.2 0.2 0.013 132 2.5 1 10 52.6

Citric Acid 1 1 0.066 105 100 1 1 0.7

Water 56

Total 100 15.2 1.033 274

* The component is not on the Chemical List and the applicant refers to references in the literature.

In the example AC is 15.2%, which is equivalent to 0.152 g per g of product.

TD has been calculated as 274 l/g AC.

Packaging

In the following the WCR has been calculated as 0.18 g/gWeight (g)

Wi Ui Di r WCR

Content per bottle 300

Weight of bottle (0% recycled) 22 22 22 300 1 0.15

Numbers of bottles per case 12

Weight of case (80% recycled) 100 100 20 3600 1 0.03

Number of cases per pallet 50

Weight of foil (0% recycled) 30 30 30 180,000 1 0.00

Total 0.18

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Appendix 4 – Substances causing endocrine disruption in accordance with the EU list

The following substances are considered to cause endocrine disruption in accordance with the EU list of substances causing endocrine disruption clas-ses 1 and 2 and that are found on the INCI-list. The EU-list and the INCI-list has been review and substances that are found on both lists are found below. The appendix is not conclusive and it is the responsibility of the producer to make the correct declaration on appendix 2. This appedix is only ment as help when applying for an ecolabel.

Since this is a flexible list, it may be extended by the addition of new sub-stances during the period of validity of the criteria. This appendix will also encompass any new substances. See R4.

Category 1 Cas-no. Category 2 Cas-no.

Styrene 100-42-5 4-chloro-3-methylphenol 59-50-7

Butylbenzylphtalate (BBP) 85-68-7 Diisodecyl phthalate 26761-40-0

Di-(2-ethylhexyl)phtalate (DEHP)

117-81-7 Diisononyl phtalate = 1,2-Benzene-dicarboxylic acid, diiso-nonyl ester (DINP)

28553-12-0

Di-n-butylphtalate (DBP) 84-74-2 o-phenylphenol 90-43-7

2,2-bis(4-hydroxyphenyl)-pro-pane = Bisphenol A

80-05-7

Resorcinol 108-46-3

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Appendic 5 – Fragrance substances that is limited

The following fragrance substances must not be present in the product in quantities exceeding 0.01%.

Name Cas-no.

Amyl cinnamal 122-40-7

Benzyl alcohol 100-51-6

Cinnamyl alcohol 104-54-1

Citral 5392-40-5

Eugenol 97-53-0

Hydroxycitronellal 107-75-5

Isoeugenol 97-54-1

Amylcinnamyl alcohol 101-85-9

Benzyl salicylat 118-58-1

Cinnamal 104-55-2

Coumarin 91-64-5

Geraniol 106-24-1

Hydroxymethylpentylcyclohexenecarboxaldehyd (Methyl heptine carbonate) 31906-04-4

Anisyl alcohol 105-13-5

Benzyl cinnamat 103-41-3

Farnesol 4602-84-0

2-(4-tert-butylbenzyl)-propionaldehyd (Lilial) 80-54-6

Linalool 78-70-6

Benzyl benzoate 120-51-4

Citronellol 106-22-9

Hexyl cinnamaldehyd 101-86-0

d-Limonen 5989-27-5

Methyl heptin carbonat 111-12-6

3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-on (γ-Methylione) 127-51-5

Oak moss 90028-68-5

Tree moss 90028-67-4

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Appendix 6 – Framework conditions for testing efficiency

These framework conditions may be used as documentation of the effecti-veness of the product. It should be noted that these points are intended as guidelines, and proposals for tests submitted by the manufacturer will also be accepted.

Consumer testing

A consumer test should encompass at least 10 test persons. The consumers should be asked how satisfied they are with the product compared with the product that they normally use. The questions put to the test persons might be formulated in the following way:

1. How does the product perform compared with the product normally used by the consumer?

2. How easy is the product to dose compared with the product normally used by the consumer?

3. How easy is the product to spread over the body/in the hair compared with the product normally used by the consumer?

At least eight of the test persons must be as satisfied with the product as they are with the product they normally use.