User Manual Cosmetics
User Manual Cosmetics
User Manual Cosmetics
rinse-off
cosmetic
products
User Manual
European Commission
EU Ecolabel rinse-off cosmetic products
EU ECOLABEL RINSE-OFF COSMETICS USER MANUAL
Commission Decision of for the award of the EU Ecolabel for rinse-off cosmetics (2014/893/EU)
1 Introduction......................................................................................................................................................................................................................... 5
1.9 Costs........................................................................................................................................................................................................................................... 7
Step 4: Assessment......................................................................................................................................................................................................................................9
Definitions...........................................................................................................................................................................................................................................................12
3(c) Ingoing substances listed in accordance with Article 59(1) of Regulation (EC) No 1907/2006 .......23
3(d) Fragrances................................................................................................................................................................................................................................... 24
Criterion 4: Packaging..................................................................................................................................................................................................................................27
Criterion 5: Sustainable sourcing of palm oil, palm kernel oil and their de rivatives ................................................................32
Part D: Declarations..............................................................................................................................................................................................40
Appendix II: test procedure for measuring the residual quantity .......................................................................... 70
Part E: Checklist................................................................................................................................................................................................... 74
Part A: General Information – Provides information about the EU Ecolabel (including a summary of the
criteria), details of the application process, and answers to frequently asked questions about applying.
Part B: Product Assessment and Verification – Outlines the criteria for rinse-off cosmetics set out in the
Commission Decision (2014/312/EU). An example from this section is shown below:
Outline of documentation
needed for application –
including link to a template
declaration form
Part C: Application Form – This application form should be completed by all applicants.
Part D: Declarations – These declarations are to be completed as part of the application process. The
relevant sections of Part B (Product Assessment and Verification) should be referred to when completing
these declarations. An example declaration is shown below:
Declaration, including
sections to be completed by
the applicant and/or
supplier(s).
Information to be
completed by the person
responsible for this
declaration
The basis for the manual is the Commission Decision of 9 December 2014 establishing the ecological criteria
for the award of the EU Ecolabel for rinse-off cosmetics (2014/893/EU). A copy of the criteria can be found
at:
http://ec.europa.eu/environment/ecolabel/products-groups-and-criteria.html
Please read the criteria document carefully before filling in the application form!
The product group “Rinse-off cosmetic products” includes products for both private and professional use.
1
This User Manual is for guidance only; it does not have any legal standing and does not, in any way, replace the
Commission Decision or any relevant legislation. In case of doubt on specific points in the Manual, please refer
directly to the national Competent Body.
Each EEA member state has nominated a Competent Body, which assesses applications for the award of the
EU Ecolabel. The choice of which competent body you should apply to is determined by the following rules:
If the product originates in one of the EEA Member States, then an application should be made to the
EU Ecolabel Competent Body of that Member State.
If your product originates from outside the EEA, you should apply to the EU Ecolabel Competent Body
of the EEA Member State in which the product is (or is about to be) placed on sale.
All EEA Member States assess applications against the same criteria, but individual States have slightly
different procedures and fee levels for handling applications. For contact details for each Member State’s
Competent Body, please visit:
http://ec.europa.eu/environment/ecolabel/competent-bodies.html
Extension with new commercial identification/reference names, which do not affect compliance with
the criteria: In this case, the relevant information should be sent to the Competent Body. After
scrutiny, and if accepted, the Competent Body will issue a revised licence with the new/additional
commercial references/trade names added.
Extension with new technical characteristics which affect compliance with the criteria (for example
new materials): These must be approved by the Competent Body before use. A request for extension
must be sent to the Competent Body together with all the necessary supporting documentation as
required in the Assessment and verification section(s) of the relevant affected criterion/criteria.
Addition or substitution of new suppliers: The Competent Body should be provided with appropriate
documentation proving the suppliers’ compliance with the criteria. In addition, an updated list of
suppliers must be provided.
All other changes should be notified to the Competent Body in any case, so that they can determine
whether or not they may affect ongoing compliance.
After an EU Ecolabel licence has been granted, the licence holder must keep the application dossier up to date.
In cases where continued tests or measurements are required, the licence holder is responsible for keeping a
record of the test results and other relevant documentation. This documentation may not need to be sent to
the Competent Body, unless there is a specific requirement to do so (which will be set out in the relevant
criterion), but must be available at any time if requested.
If at any time during the validity period of the licence the product falls out of compliance with the
criteria this must be reported to the Competent Body immediately, together with a statement of
the reasons for non-compliance. The Competent Body will decide the consequences of the non -
compliance, e.g. a demand for additional measurements, suspension of the licence etc.
1.9 Costs
The applicant is responsible for compiling the application and obtaining all the necessary supporting evidence,
which may include tests etc.
In addition the applicant must pay an application fee 2, and an annual licence fee where this is asked for by
the Competent Body. In some cases, applicants may be charged for an on-site verification, which may include
travel and accommodation costs. Subsequent to the award of the licence, Competent Bodies may also charge
for extension/modification fees and on-site inspections. Further information can be found at:
http://ec.europa.eu/environment/ecolabel/documents/eu-ecolabel_fees.pdf
2
According to the Commission Regulation (EU) No 782/2013 of 14 August 2013 amending Annex III to the
Regulation (EC) No 66/2010 of the European Parliament and of the Council on the EU Ecolabel 25 November
2009.
The contact details of all the EU Ecolabel Competent Bodies are available at:
http://ec.europa.eu/environment/ecolabel/competent-bodies.html
Figure 1 outlines the stages involved in applying for the EU Ecolabel. Further detail is given in the
explanations that follow.
Follow the instructions on the E-Catalogue User Manual which you can download from
http://ec.europa.eu/environment/ecolabel/ecolabelled_products/pdf/user_manual/Ecat_admin%20user%20man
ual%20for%20Applicants.pdf. This user manual outlines the process for registration, which will include
registering under the European Commission Authentication Service (ECAS) system. If you have any problems
using the system, contact your Competent Body or the Ecolabel Helpdesk.
All test and independent verification costs must be met by the applicant. You should factor in these
costs before you decide to apply.
Send all of the documents required (typically a completed and signed copy (or copies) of the application
form, the filled in calculation spreadsheet and the application dossier – the number of copies and format of
these may vary by Member State), to the relevant Member State Competent Body. For further information,
please contact your Competent Body.
Step 4: Assessment
After receiving an application, the Competent Body examines the documentation including any material sent
directly by suppliers. The Competent Body can ask for further information if necessary, within two months of
receipt of an application. The Competent Body may make a list of any additional documentation required in
order to comply with the EU Ecolabel product group criteria. This list will be forwarded to the applicant who
must ensure that the relevant documentation is provided.
It should also be noted that a Competent Body can reject an application if all the relevant
documentation is not received within 6 months of the initial application.
After all the documentation has been approved, the Competent Body may carry out an on -site visit to the
applicant and/or its suppliers. The Competent Body makes this judgement on a case -by-case basis and may
charge for it. Again, please contact your Competent Body for details.
Once the contract is signed by the applicant, a certificate can be requested. This certificate will detail:
the licence number that can be used with the EU Ecolabel logo ;
Upon receipt of the signed contract, the licence holder can use the EU Ecolabel logo and licence number on
the relevant products in accordance with the EU Ecolabel Logo guideline s, which can be found at:
http://ec.europa.eu/environment/ecolabel/documents/logo_guidelines.pdf
Revision of criteria
The criteria for each product group are revised every three/four years, and existing EU Ecolabel holders
have to re-apply when these new, revised criteria come into force. Therefore, it is advisable to consider the
timing of your application to avoid consecutive application and then re-application under new criteria. A
transition period for adjusting the product(s) formulation and applying for re -assessment is usually allowed
for and is set out in the new criteria document.
For more information about the application process visit the EU Ecolabel website at:
http://ec.europa.eu/environment/ecolabel/how-to-apply-for-eu-ecolabel.html
Tick when
Reference Requirement
complete
3
For information about the criteria revision, please visit the website
http://ec.europa.eu/environment/ecolabel/products-groups-and-criteria.html
EU ECOLABEL RINSE-OFF COSMETICS USER MANUAL
Commission Decision of for the award of the EU Ecolabel for rinse-off cosmetics (2014/893/EU)
Definitions
The following definitions shall apply to references throughout this User Manual, and in reference to the
original Criteria document:
1. "ingoing substances" means preservatives, fragrances and colorants, regardless of the
concentration, and other substances intentionally added, by-products and impurities from raw
materials, the concentration of which equals or exceeds 0.010 % by weight of final formulation ;
This means that:
a) active substances with dedicated function as preservatives, fragrances or colorants, re gardless of
concentration;
b) all other substances intentionally added, by-products and impurities from raw materials, the
concentration of which equals or exceeds 0.010 % by weight of final formulation;
2. "active content" (AC) means the sum of organic ingoing substances in the product (expressed in
grams), calculated on the basis of the complete formulation of the product, including propellants
contained in aerosol products. Rubbing/abrasive agents are not included in the calculation of the
active content;
3. "primary packaging" means packaging in direct contact with the content conceived so as to
constitute the smallest sales unit of distribution to the final user or consumer at the point of
purchase in direct contact with the content;
4. "secondary packaging" means packaging which can be removed from the product without
affecting its characteristics and is conceived so as to constitute at the point of purchase a grouping
of a certain number of sales units whether the latter is sold as such to the final user or c onsumer or
whether it serves only as a means to replenish the shelves at the point of sale.
Where the applicant is required to provide declarations, documentation, analyses, test reports, or other
evidence to show compliance with the criteria, these may originate from the applicant or his supplier(s) or
both.
Where possible, the testing shall be performed by laboratories that meet the general requirements of
European Standard EN ISO 17025 or equivalent.
Where appropriate, test methods other than those indicated for each criterion may be used if the competent
body assessing the application accepts their equivalence .
Where appropriate, competent bodies may require supporting documentation and may carry ou t independent
verifications.
The Appendix makes reference to the "Detergent Ingredient Database" list (DID list) which contains the most
widely used ingredients used in detergents and cosmetics formulations. It shall be used for deriving the data
for the calculations of the Critical Dilution Volume (CDV) and for the assessment of the biodegradability of
the ingoing substances. For substances not present on the DID list, guidance is given on how to calculate or
extrapolate the relevant data. The latest version of the DID list is available from the EU Ecolabel website4 or
via the websites of the individual competent bodies.
http://ec.europa.eu/environment/ecolabel/documents/did_list/didlist_part_a_en.pdfhttp://ec.europa.eu/en
vironment/ecolabel/documents/did_list/didlist_part_b_en.pdf
(i) The full formulation of the product indicating trade name, chemical name, CAS number and INCI
designations, DID number5, the ingoing quantity including and excluding water, the function and the form
of all ingredients regardless of concentration;
(ii) Safety data sheets for each ingoing substance or mixture in accordance with Regulation (EC) No
1907/2006 of the European Parliament and of the Council6.
Interpretation of criteria:
The information requested above is also requested as part of criterion 3(b). The information does not need to
be sent more than once.
Safety data sheets 'provide comprehensive information about a substance or mixture for use in workplace
chemical control regulatory frameworks. Both employers and workers use it as a source of information about
hazards, including environmental hazards, and to obtain advice on safety precautions.7.
CAS numbers are unique numerical identifiers assigned by the Chemical Abstracts Service to every chemical
substance described in the open scientific literature.
INCI (International Nomenclature of Cosmetic Ingredients) are standardised scientific names for all cosmetic
ingredients. These allow ready identification of ingredients rather than the used of trade or common names.
Measurement thresholds for compliance verification are given for each criterion in below table:
Crit. 1 Crit. 2a Crit. 2b Crit. 3a Crit. 3b Crit. 3c Crit. 3d Crit. 3e Crit. 3f Crit. 5
surfactants ≥ 0,010 ≥ 0,010 ≥ 0,010 ≥ 0,010 ≥0,010 ≥0,010 x x x ≥ 0,010
no no no no
preservatives x ≥0,010 ≥0,010 x x x
limit* limit* limit* limit*
no no no no
colorants x ≥0,010 ≥0,010 x x x
limit* limit* limit* limit*
no no no no
fragrances x ≥0,010 ≥0,010 x x x
limit* limit* limit* limit*
other ≥ 0,010 x ≥ 0,010 ≥ 0,010 ≥0,010 ≥0,010 x x x x
* no limit means: regardless of the concentration, all substances intentionally added, by-products and
impurities from raw materials (analytical limit of detection )
5
DID no. is the number of the ingoing substance on the DID list;
6
OJ L 396, 30.12.2006, p.1.
7
European Chemical Agency, Guidance on the compilation of safety data sheets, February 2014.
The total CDV toxicity of the product shall not exceed the limits in Table 1:
𝐂𝐃𝐕 = ∑ 𝐂𝐃𝐕 (𝐢𝐧𝐠𝐨𝐢𝐧𝐠 𝐬𝐮𝐛𝐬𝐭𝐚𝐧𝐜𝐞 𝐢) = ∑ 𝐰𝐞𝐢𝐠𝐡𝐭 (𝐢) × 𝐃𝐅(𝐢) × 𝟏𝟎𝟎𝟎 / TFchronic (i)
Where:
weight (i) - is the weight of the ingoing substance (in grams) per 1 gram of AC (i.e. normalised weight
contribution of the ingoing substance to the AC)
DF (i) - is the degradation factor of the ingoing substance
TF chronic (i) - is the toxicity factor of the ingoing substance (in milligrams/litre).
Interpretation of criteria:
CDV expresses the amount of water needed for the hypothetical dilution of a product at which the product
can be considered to have no environmental impact. The unit is expressed in litres per functional unit.
DF (degradation factor) is based on how readily biodegradable the substance is. It is calculated based on test
results on the substance using methods described in Annex 1 and using the DID list-Part B, table 1.
DF and TF Chronic are usually within the DID list part A. Where they are not available they can either be
estimated or calculated using testing procedures described in Appendix I
The applicant shall provide the calculation of the CDV of the product. A spreadsheet for calculation of the
CDV value is available on the EU Ecolabel website.
The values of DF and TF chronic shall be as given in the DID list-part A. If the ingoing substance is not
included in the DID list-part A, the applicant shall determine the values using the guidelines described in
the DID list-part B and attaching the associated documentation (for more information see Appendix I).
Interpretation of criteria:
The spreadsheet for calculation of the CDV of the product can be found here:
http://ec.europa.eu/environment/ecolabel/documents/Calculation%20Sheet%20cosmetics.xlsx
A calculation of all recipes/formulation shall be made. A recipe can cover several products (trade names). If a
recipe covers more than one trade name this shall be clearly indicated.
Criterion 2: Biodegradability
Solid soaps 10 10
Hair conditioners 45 45
The applicant shall provide documentation for the degradability of surfactants, as well as the calculation
of aNBO and anNBO for the product. A spreadsheet for calculation of aNBO and anNBO values is
available on the EU Ecolabel website.
For both surfactants and aNBO and anNBO values, reference shall be made to the DID list. For ingoing
substances which are not included in the DID list, the relevant information from literature or other
sources, or appropriate test results, showing that they are aerobically an d anaerobically biodegradable
shall be provided as described in Appendix I.
In the absence of documentation in accordance with the above requirements, an ingoing substance other
than a surfactant may be exempted from the requirement for anaerobic degradabi lity if one of the
following three alternatives is fulfilled:
Testing for adsorption/desorption may be conducted in accordance with OECD guidelines 106.
Declaration: Biodegradability
Interpretation of criteria:
‘Surfactant’ means any organic substance and/or mixture used in detergents, which has surface -active
properties and which consists of one or more hydrophilic and one or more hydrophobic groups of such a
nature and size that it is capable of reducing the surface tension of water, and of forming spreading or
adsorption monolayers at the water-air interface, and of forming emulsions and/or microemulsions and/or
micelles, and of adsorption at water-solid interfaces (Regulation (EC) No 648/2004).
The total aNBO and anNBO can be determined by summing the concentration of each organic ingoing
substance which is classified aNBO or anNBO:
and
Where
Low adsorption means that the substance will not enter into or attach to the surface of solid material
whereas high desorption means that a substance will readily remove itself from the surface of a solid
material and enter into water.
Rubbing/abrasive agents are not included in the calculation of the active content and should not be
considered in the aNBO and anNBO calculation.
(i) Alkyl phenol ethoxylates (APEOs) and other alkyl phenol derivatives;
(vii) Ethylenediaminetetraacetate (EDTA) and its salts and non -readily biodegradable phosphonates;
(viii) The following preservatives: triclosan, parabens, formaldehyde and formaldehyde releasers.
(ix) The following fragrances and ingredients of fragrance mixtures: Hydroxyisohexyl 3-cyclohexene
carboxaldehyde (HICC), Atranol and Chloroatranol.
(x) Micro-plastics;
(xi) Nanosilver8.
The applicant shall provide a signed declaration of compliance supported by declarations from
manufacturers of mixtures, as appropriate, confirming that the listed substances and/or mixtures have
not been included in the product above defined concentrations.
8
Also called micro-beads.
specified in Table 3 in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the
Council9 or Council Directive 67/548/EC 10 or substances referred to in Article 57 of Regulation (EC) No
1907/2006. In case the threshold for classification of a substance or mixture with a hazard statement differs
from the one of a risk phrase than the former prevails. The risk phrases in Table 3 generally refer to
substances. However, if information on substances cannot be obtained, the classification rules for mixtures
apply.
Interpretation of criteria:
Risk phrases are a list of codes that designate the environmental or health risks associated with the
substance. Hazard statements are phrases which describe the nature of the hazard in a substance or
mixture.
The risk phrases in Table 4 also generally refer to substances. However, if information on substances cannot
be obtained, the classification rules for mixtures apply.
Substances or mixtures which change their properties through processing and thus become no longer
bioavailable, or undergo chemical modification in a way that removes the previously identified hazard are
exempted from criterion 3 (b).
Interpretation of criteria:
Chemicals that undergo a reaction can be considered exempt from this criterion. However, the reaction
products shall be declared and are subject to the conditions of this criterion.
9
OJ L 353, 31.12.2008, p. 1.
10
OJ 196, 16.8.1967, p. 1.
Sensitising substances
Hazard Statement Risk Phrase
H334: May cause allergy or asthma symptoms or breathing difficulties if
R42
inhaled
H317: May cause allergic skin reaction R43
For rinse-off cosmetic products, the substances in Table 4 are exempted from the obligation in Article 6(6) of
Regulation (EC) No 66/2010 following application of Article 6(7) of the same Regulation.
The applicant shall demonstrate compliance with criterion 3(b) for any ingoing substance or mixture
present at concentrations greater than 0.010 % in the final product.
A declaration of compliance shall be provided by the applicant supported, where appropriate, by the
declarations from producer(s) of the raw materials that none of these ingoing substances and/or
mixtures meet the criteria for classification with one or mo re of hazard statements or risk phrases listed
in Table 3 in the form(s) and physical state(s) they are present in the product.
The following technical information related to the form(s) and physical state(s) of the ingoing substances
and/or mixtures as present in the product shall be provided to support the declaration of non -
classification:
(i) For substances that have not been registered under Regulation (EC) No 1907/2006 and/or which
do not yet have a harmonised CLP classification: Information meeting the requirements listed in
Annex VII to that Regulation;
(ii) For substances that have been registered under Regulation (EC) No 1907/2006 and which do not
meet the requirements for CLP classification: Information based on the REACH registration dossier
confirming the non-classified status of the substance;
(iii) For substances that have a harmonised classification or are self -classified: safety data sheets
where available. If these are not available or the substance is self-classified then information shall
be provided relevant to the substances hazard classification according to Annex II to Regulation
(EC) No 1907/2006;
(iv) In the case of mixtures: safety data sheets where available. If these are not available then
calculation of the mixture classification shall be provided according to the rules under Regulation
(EC) No 1272/2008 together with information relevant to the mixtures hazard classification
according to Annex II to Regulation (EC) No 1907/2006.
For substances listed in Annexes IV and V to Regulation (EC) No 1907/2006, which are exempted from
registration obligations under point (a) and (b) of Article 2(7) of that Regulation, a declaration to this
effect by the applicant shall suffice to comply with criterion 3 (b).
A declaration on the presence of ingoing substances that fulfil the derogation conditions shall be
provided by the applicant, supported, where appropriate, by declarations from the producer(s) of the raw
materials. Where required for the derogation, the applicant shall confirm the concentrations of these
ingoing substances in the final product.
Interpretation of criteria:
There are two parts to the declaration:
11
Available at: http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp
Interpretation of criteria:
Substances of Very High Concern are substances that may have serious and often irreversible effects on
human health and the environment. Where identified, they are included in a list of substances that are under
tight control for which special permission must be sought before their use. The European Chemicals Agency
ECHA, maintain a list of these substances, which is available at:
http://www.echa.europa.eu/addressing-chemicals-of-concern/restrictions/list-of-restrictions/list-of-
restrictions-table
The applicant shall provide a declaration of compliance with criterion 3(c), together with related
documentation, such as declarations of compliance signed by the material suppliers and copies of
relevant safety data sheets for substances or mixtures. Reference to the list of substances identified as
substances of very high concern shall be made on the date of application.
Declaration: Ingoing substances listed in accordance with Article 59(1) of Regulation (EC) No 1907/2006
Supplier Declaration: Ingoing substances listed in accordance with Article 59(1) of Regulation (EC) No
1907/2006
3(d) Fragrances
(i) Products marketed as designed and intended for children shall be fragrance -free.
Interpretation of criteria:
For the purpose of this criterion, a child is defined as a person “below the age of eighteen years unless, under
the law applicable to the child, majority is attained earlier.” (Part I, Article 1 of the U.N. General Assembly
Convention on the Rights of the Child).
The manufacturer will need to provide an example of their product and marketing materials to show their
intended target audience. Use of words like baby, infant, child, kid (and plural thereof) will indicate the
intended market for the product.
(ii) Any ingoing substance or mixture added to the product as a fragrance shall be manufactured and
handled following the code of practice of the International Fragrance Association (IFRA). The code
can be found on the IFRA website: http://www.ifraorg.org . The recommendations of the IFRA
Standards concerning prohibition, restricted use and specified purity criteria for materials shall be
followed by the manufacturer.
The applicant shall provide a signed declaration of compliance, supported by a declaration of the
fragrance manufacturer, as appropriate.
Declaration: Fragrances
Interpretation of criteria:
The IFRA code of practice can be found at:
http://admin-ifra.alligence.com/Files/Documents/1/en-
us/GD/22156_GD_2006_12_15_IFRA_Code_of_Practice_ -_Body_&_8_Appendices_-_Dec_2006.pdf
Specific information on how fragrances should be manufactured and handled can be found under appendix 6:
IFRA Recommendations for Good Operating Practice.
http://www.ifraorg.org/en/standards
3(e) Preservatives
(i) Preservatives in the product shall not release or degrade to substances that are classified in
accordance with the requirements of criterion 3 (b).
(ii) The product may contain preservatives provided that they are not bioaccumulating. A
preservative is not considered bioaccumulating if BCF < 100 or log Kow < 3,0. If both – BCF and
logKow – values are available, the highest measured BCF value shall be used.
Interpretation of criteria:
Bioaccumulation of substances within aquatic organisms can give rise to toxic effects over longer time scales
even when actual water concentrations are low. For organic substances the potential for bioaccumulation
shall normally be determined by using the octanol/water partition coefficient, usually reported as a log K ow .
The relationship between the log Kow of an organic substance and its bioconcentration is measured by the
bioconcentration factor (BCF).12
12
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on
classification, labelling and packaging of substances and mixtures, amending and repealing Directives
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 , OJ L 353, 31.12.2008 , p. 1.
The applicant shall provide a signed declaration of compliance, together with copies of the safety data
sheets of any preservative added, and information on its BCF and/or log Kow values.
Declaration: Preservatives
3(f) Colorants
Colorants in the product must not be bioaccumulating. A colorant is considered not bioaccumulating if BCF <
100 or log Kow < 3.0. If both – BCF and log Kow – values are available, the highest measured BCF value shall
be used.
In the case of colouring agents approved for use in food, it is not necessary to submit documentation of
bioaccumulation potential.
The applicant shall provide copies of the safety data sheets of any colorant added together with
information on its BCF and/or log Kow value, or documentation to ensure that the colouring agent is
approved for use in food.
Declaration: Colorants
Criterion 4: Packaging
No additional packaging for the product as it is sold, e.g. carton over a bottle, is allowed, with the exception of
secondary packaging which groups two or more products together (e.g. the product and refill).
Pre-shaving products packed in metal aerosol containers are exempted from this requirement.
Interpretation of criteria:
Pre-shaving products are products used to protect the epidermis and lubricate the hair before shaving; they
can be in from of gel, foam, or cream.
Where:
13
Proportional weight of the grouping packaging (e.g. 50% of the total grouping packaging weight, if two
products are sold together).
Where;
V – volume capacity of the parent pack (ml)
Vrefill – volume capacity of the refill pack (ml)
R – the refillable quantity. This is the number of times that the parent pack can be refilled. Where F is
not a whole number it should be rounded up to the next whole number.
The manufacturer shall provide the number of foreseen refilling, or use the default values of R = 5 for
plastics and R = 2 for cardboard.
Interpretation of criteria:
The Packaging Impact Ration (PIR) should be calculated as gram of packaging per gram of product.
The applicant shall provide evidence on the expected number of refills of their packaging (where appropriate)
and not use the default values.
The applicant shall provide the calculation of the PIR of the prod uct. A spreadsheet for this calculation is
available on the EU Ecolabel website. If the product is sold in different packaging (i.e. with different
volumes), the calculation shall be submitted for each packaging size for which the EU Ecolabel shall be
awarded.
The applicant shall provide a signed declaration for the content of post-consumer recycled material or
material from renewable origin in the packaging and a description of the refill system offered, if
applicable (kinds of refills, volume).
For approval of refill packaging, the applicant or retailer shall document that the refills shall be available
for purchase on the market.
Declaration: Packaging Impact Ratio – to be completed only where refills are available
Interpretation of criteria:
For products for which refills are available the applicant needs to provide evidence that they produce and sell
refills. This evidence may be, for example, product packaging or marketing materials.
http://ec.europa.eu/environment/ecolabel/documents/Calculation%20Sheet%20cosmetics.xlsx
Where:
Interpretation of criteria:
Examples of ensuring that the correct dosage is being delivered could also include a correct size pump
dispenser.
The applicant shall submit a description of the dosage device and test report with results of measuring
the residual quantity of a rinse-off cosmetic product in the packaging. The test can be done externally or
internally. The test procedure for measuring the residual quantity is described in Appendix II of this
Manual.
Interpretation of criteria:
This calculation should be performed separately for each size packaging.
Interpretation of criteria:
Barrier coatings are thin films that provide a specific property to a container. For example, very thin
aluminium can be used to block light or reduce gas permeability of plastic.
14
EVA – Ethylene Vinyl Acetate, EVOH – Ethylene vinyl alcohol, HDPE – High-density polyethylene, PET –
Polyethylene terephtalate, PETG – Polyethylene terephtalate glycol-modified, PP – Polypropylene, PS –
Polystyrene, PVC – Polyvinylchloride.
Required documentation for Assessment and verification: Design for recycling of plastic
packaging
The applicant shall submit a signed declaration of compliance specifying the material composition of the
packaging including the container, label or sleeve, adhesives, closure and barrier coating, and a sample
of primary packaging.
Palm oil and palm kernel oil and their derivatives used in the product must be sourced from plantations that
meet criteria for sustainable management that have been developed by multi -stakeholders organisations
who have a broad based membership including NGOs, industry and government.
The applicant shall provide third-party certifications that the palm oil and palm kernel oil used in the
manufacturing of the product (ingredient and/or used as part of ingredient) originates from sustainable
managed plantations. Certifications accepted shall include RSPO (by identity preserved, segregated or
mass balance) or any equivalent scheme based on multi-stakeholder sustainable management criteria.
For chemical derivatives of palm oil and palm kernel oil15 it is acceptable to demonstrate sustainability
for these through book and claim systems such as GreenPalm or equivalent.
Declaration: Sustainable sourcing of palm oil, palm kernel oil and their derivatives
Supplier Declaration: Sustainable sourcing of palm oil, palm kernel oil and their derivatives
Interpretation of criteria:
Palm oil is pressed from the flesh of the fruits of the oil palm tree.
Palm kernel oil is produced from the kernel (or stone) of the fruit of the oil palm tree.
Derivatives: Further processing of the palm oil and palm kernel oil can produce a range of de rivatives and
fractions. See definition and scope at Appendix III.
The Roundtable of Sustainable Palm Oil (RSPO): A not for profit organisation that was set up to promote the
production and use of sustainable palm oil. It has members from producers, retailers, manufactures and
NGOs.
Green Palm is a system by which manufacturers that use palm oil can purchase certificates from RSPO
certified plantations and thus support the production of sustainable palm oil. It removes the need to source
specific plantations and control the sustainable palm oil supply chain.
15
As defined by the RSPO in the “RSPO Rules for Home and Personal Care Derivatives”, available at:
http://www.greenpalm.org/upload/files/45/RSPO_Guiding_Rules_for_HPC_derivativesV9.pdf.
The product’s capacity to fulfil its primary function (e.g. cleaning, conditioning) and any secondary functions
claimed (e.g. anti-dandruff, colour protection, etc.) shall be demonstrated either through laboratory test(s) or
a consumer test. The tests shall be conducted following the "Guidelines for the Evaluation of the Efficacy of
Cosmetic Products".
The applicant shall document the test protocol that has been followed in order to test the product's
efficacy. Applicants shall present results from this protocol that demonstrate that the product fulfils the
primary function and secondary functions claimed o n the product label or packaging.
Interpretation of criteria:
The Guidelines for the Evaluation of the Efficacy of Cosmetic Products is available to download here:
https://www.cosmeticseurope.eu/publications-cosmetics-europe-association/guidelines.html?view=item&id=23
See Appendix IV for additional guidance for fitness for use testing.
The optional label with text box shall contain the following text:
The guidelines for the use of the optional label with text box can be found in the "Guidelines for use of the
Ecolabel logo" on the website:
http://ec.europa.eu/environment/ecolabel/documents/logo_guidelines.pdf
The applicant shall provide a sample of the product label or an artwork of the packaging where the EU
Ecolabel is placed, together with a signed declaration of compliance.
Please contact your Competent Body to learn how your completed application form and supporting
documentation should be submitted.
See section 1.4 in Part A, “Where do I apply?” for further details of where to send your application once
completed.
Applicants should also provide a technical dossier of laboratory test reports and send this in duplicate
to the Competent Body, and keep an up-to-date file on their premises showing continuing compliance with
the criteria. Equivalent test methods, others than the ones indicated by the formal Commission Decision may
be used provided the test methods have been approved by the awarding Competent Body.
Applicant information
Applicant’s full company name and address:
Contact person:
Position:
Phone:
Fax:
Email:
Website:
Service provider….☐
Wholesaler….☐
Retailer….☐
Product Information
What product group are you applying for? Shampoo, shower preparations and liquid soaps ☐
Solid soaps ☐
Hair conditioners ☐
In case the product is made outside the European [insert name of country where application is received]
Economic Area market (European Union plus
Iceland, Lichtenstein and Norway), please confirm
the country where it has been or will be placed on
the market.
Application fees:
An invoice will be sent when the application and the attached declarations are received. Before the
application can be processed, the applicant must pay the application fee relevant for the company. Please
refer to your Competent Body for fees.
This declaration is to be used so that the Competent Body can set the appropriate application and eventually
annual licence fees for the EU Ecolabel cf. Regulation (EC) No 66/2010 of The European Parliament and of
The Council of 25 November 2009 on the EU Ecolabel appendix III.
All questions below have to be answered before handling of the application can begin.
Is the company registered under EMAS and/or certified under ISO 14001 and
has the company in its environmental policy, committed to maintain Yes… ☐
compliance of its EU Ecolabel products with the EU Ecolabel product group No…. ☐
criteria throughout the contract’s period of validity?16
Date:
Company Name:
Company Stamp:
16
If confirmed the company must send a copy of the annual affirmative environmental statement (EMAS) or valid
ISO 14001 certificate and copy of the companies environmental policy and objectives (ISO 14001) in connection
with the application and information on the annual turnover.
Applicant’s undertaking
As the applicant for an EU Ecolabel, I hereby declare that:
I understand and accept the provisions of Regulation EC No. 66 / 2010 on the EU Ecolabel scheme, and in
particular Article 6, paragraph 6, which states that the EU Ecolabel may not be awarded to goods containing
substances or preparations/ mixtures meeting the criteria for classification as toxic, hazardous to the
environment, carcinogenic, mutagenic or toxic for reproduction (CMR), in accordance with Regulation (EC) No
1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling
and packaging of substances and mixtures [11], nor to goods containing substances referred to in Article 57
of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a
European Chemicals Agency. (Note that article 7 enables the Commission to adopt measures to grant
derogations from paragraph 6 under certain conditions);
I undertake to ensure that the product compiles with the EU Ecolabel criteria at all times and to notify
[*_________________________________________________________________________________________
______] immediately of any significant modification to it or to the production processes.
I take responsibility for the correct and proper use of the EU Ecolabel logo.
Signed:
Name in capitals:
Position in company:
Date:
Company stamp:
Part D: Declarations
Summary of declarations:
Click to view and print
Criterion 1: Toxicity to aquatic organisms: CDV
Criterion 2: Biodegradability
Criterion 5: Sustainable sourcing of palm oil, palm kernel oil and their derivatives
The spreadsheet for calculating the CDV of the product can be found at:
http://ec.europa.eu/environment/ecolabel/documents/Calculation%20Sheet%20cosmetics.xlsx
I the undersigned, hereby declare that the CDV of the product does not exceed the maximum limits set out
below.
Product Maximum CDV value
Shampoo, shower preparations and liquid soaps: 18 000
Solid soaps: 3 300
Hair conditioners: 25 000
Shaving foams, shaving gels, shaving creams : 20 000
Shaving solid soaps: 3 300
I also confirm that CDV values have been calculated using the relevant CDV calculation spreadsheet (please
attach this to the application ).
Please complete the table below to show actual CDV values as a result of this calculation.
Product
Actual CDV Value
(please specify a product type , e.g. shampoo)
Position held:
Date:
Company Stamp:
I the undersigned, hereby declare that all surfactants are readily biodegradable under aerobic and
biodegradable under anaerobic conditions as shown on the table below.
I also declare that that the total concentration (mg/g of Active Compound) of non-biodegradable (not readily
biodegradable) (aNBO) and anaerobically non-biodegradable (anNBO) ingoing organic substances does not
exceed the following maximum concentrations:
Ingoing substance other than a surfactant may be exempted from the requirement for anaerobic
degradability if one of the following three alternatives is fulfilled:
(1) Readily degradable and has low adsorption (A < 25%,);
(2) Readily degradable and has high desorption (D > 75%);
(3) Readily degradable and non-bioaccumulating.
Please complete the table below to show actual aNBO and anNBO values for the product.
Product aNBO anNBO
(please specify, e.g. shampoo) (mg/g AC) (mg/g AC)
Except where the substance is on the DID list, please attach additional information to support the claims
made against each organic ingoing substance. Guidance for this is provided in Appendix I. Testing for
adsorption/desorption may be conducted in accordance with OECD guidelines 106.
Position held:
Date:
Company Stamp:
I the undersigned, hereby declare that the following ingoing substances and mixtures have not been included
in the product, neither as part of the formulation nor as part of any mixture included in the formulation:
(i) Alkyl phenol ethoxylates (APEOs) and other alkyl phenol derivatives;
(ii) Nitrilo-tri-acetate (NTA);
(iii) Boric acid, borates and perborates;
(iv) Nitromusks and polycyclic musks;
(v) Octamethylcyclotetrasiloxane (D4);
(vi) Butylated Hydroxi Toluene (BHT);
(vii) Ethylenediaminetetraacetate (EDTA) and its salts and non-readily biodegradable phosphonates;
(viii) Preservatives: triclosan, parabens, formaldehyde and formaldehyde releasers.
(ix) Fragrances and ingredients of fragrance mixtures: Hydroxyisohexyl 3 -cyclohexene carboxaldehyde
(HICC), Atranol and Chloroatranol.
(x) Micro-plastics;
(xi) Nanosilver.
Position held:
Date:
Company Stamp:
I the undersigned, hereby declare that the following ingoing substances and mixtures have not been included
in the supplied components, neither as part of the formulation nor as part of any mixture included in the
formulation:
(i) Alkyl phenol ethoxylates (APEOs) and other alkyl phenol derivatives;
(ii) Nitrilo-tri-acetate (NTA);
(iii) Boric acid, borates and perborates;
(iv) Nitromusks and polycyclic musks;
(v) Octamethylcyclotetrasiloxane (D4);
(vi) Butylated Hydroxi Toluene (BHT);
(vii) Ethylenediaminetetraacetate (EDTA) and its salts and non-readily biodegradable phosphonates;
(viii) The following preservatives: triclosan, parabens, formaldehyde and formaldehyde releasers.
(ix) The following fragrances and ingredients of fragrance mixtures: Hydroxyisohexyl 3 -cyclohexene
carboxaldehyde (HICC), Atranol and Chloroatranol.
(x) Micro-plastics;
(xi) Nanosilver.
Position held:
Date:
Company Stamp:
I, the undersigned hereby confirm that the Excel document attached to the application
[http://ec.europa.eu/environment/ecolabel/documents/Calculation% 20Sheet% 20cosmetics.xlsx] provides a full
formulation of the product indicating trade name, chemical name, CAS no. and INCI designations , risk or
hazard phrases, DID no., the ingoing quantity including and excluding water, the function and the form of all
ingredients (greater than 0.010).
Safety data sheets for each ingoing substance or mixture in accordance with Regulation (EC) No 1907/2006
of the European Parliament and of the Council 17 shall be provided to the competent body.
Position held:
Date:
Company Stamp:
17
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning
the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a Europe an Chemicals
Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation
(EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC
and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
NOTE: The following technical information related to the form(s) and physical state(s) of the ingoing substances and/or
mixtures as present in the product shall be provided to support the declaration of non-classification:
(i) For substances that have not been registered under the REACH Regulation or which do not yet have a harmonised
CLP classification: Information meeting the requirements listed in Annex VII to the REACH Regulation;
(ii) For substances that have been registe red under the REACH Regulation and which do not meet the requirements for
CLP classification: Information based on the REACH registration dossier confirming the non-classified status of the
substance;
(iii) For substances that have a harmonized classification or are self-classified: safety data sheets where available. If
these are not available or the substance is self-classified then information shall be provided relevant to the
substances hazard classification according to Annex II to the REACH Regulation;
(iv) In the case of mixtures: Safety data sheets where available. If these are not available then calculation of the
mixture classification shall be provided according to the rules under Regulation (EC) No 1272/2008 together with
information relevant to the mixtures hazard classification according to Annex II to Regulation (EC) No 1907/2006.;
Position held:
Date:
Company Stamp:
NOTE: The following technical information related to the form(s) and physical state(s) of the ingoing sub stances and/or
mixtures as present in the product shall be provided to support the declaration of non-classification:
(i) For substances that have not been registered under the REACH Regulation or which do not yet have a harmonised
CLP classification: Information meeting the requirements listed in Annex VII to the REACH Regulation;
(ii) For substances that have been registered under the REACH Regulation and which do not meet the requirements for
CLP classification: Information based on the REACH registratio n dossier confirming the non-classified status of the
substance;
(iii) For substances that have a harmonized classification or are self-classified: safety data sheets where available. If
these are not available or the substance is self-classified then info rmation shall be provided relevant to the
substances hazard classification according to Annex II to the REACH Regulation;
(iv) In the case of mixtures: Safety data sheets where available. If these are not available then calculation of the
mixture classification shall be provided according to the rules under Regulation (EC) No 1272/2008 together with
information relevant to the mixtures hazard classification according to Annex II to Regulation (EC) No 1907/2006.;
Position held:
Date:
Company Stamp:
I the undersigned, hereby declare that the following substances listed in Annexes IV and V to Regulation (EC)
No 1907/2006, which are exempted from registration obligations under point (a) and (b) of Article 2(7) of that
Regulation, are present in the product:
Position held:
Date:
Company Stamp:
I the undersigned, hereby declare that the following ingoing substances and mixtures fulfil the derogation
conditions as outlined in Table 4, Derogated substances (page 12) of the Decision 2014/893/EU.
Total concentration:______%
Position held:
Date:
Company Stamp:
I, the undersigned, hereby declare that ingoing substances identified as “substances of very high concern” and
included in the list provided for in Article 59(1) of Regulation (EC) No 1907/2006, are not present in the final
product.
I declare that I have collected all necessary information from my suppliers to prove compliance with this
criterion.
Signature of person bearing legal responsibility:
Position held:
Date:
Company Stamp:
hereby declare that these ingoing substances are not identified as “substances of very high concern” and
included in the list provided for in Article 59(1) of Regulation (EC) No 1907/2006 .
Position held:
Date:
Company Stamp:
Position held:
Date:
Company Stamp:
I the undersigned, hereby declare that the recommendations of the IFRA Standards concerning prohibition,
restricted use and specified purity criteria for materials are followed during manufacture.
Position held:
Date:
Company Stamp:
(i) The following preservatives are used in the rinse -off cosmetic product(s) and
(ii) These preservatives do not release or degrade to substances that are classified in accordance with
the requirements of criterion 3 (b) and
(iii) The preservatives used in the product are not bioaccumulating.
Note: A preservative is considered not bioaccumulating if BCF < 100 or logK ow < 3.0. If both – BCF and logK ow – values are
available, the highest measured BCF value shall be used.
Position held:
Date:
Company Stamp:
I, the undersigned, hereby declare that colorants are/are not added (please delete as appropriate).
Where they are added, they are listed below and I declare that they are not bioaccumulating.
Note: A colorant is considered not bioaccumulating if BCF < 100 or logK ow < 3.0. If both – BCF and logK ow – values are
available, the highest measured BCF value shall be used. In the case of colouring agents approved for use in food, it is not
necessary to submit documentation of bioaccumulation potential.
Where applicable, please attach documentation demonstrating that the colorants are approved for
use in food.
Company Stamp:
I, the undersigned, hereby declare that primary packaging is in direct contact with product contents.
I also confirm that no additional packaging for the product (e.g. carton over a bottle) is used, with the
exception of secondary packaging which groups two or more products together (e.g. the product and refill).
Position held:
Date:
Company Stamp:
I also confirm that this value has been calculated using the relevant PIR calculation spreadsheet (please attach
this to the application.)
Note: If the product is sold in different packaging (i.e. with different volumes), the calculation shall be submitted for eac h
packaging size.
Position held:
Date:
Company Stamp:
I the undersigned, hereby declare that product refills are available for purchase on the market.
Please describe the type of refill system offered (such as kinds of refills, volume etc.) in the box
below:
Please also attach evidence that refills are available for purchase (such as a photograph of the
refill etc.)
Position held:
Date:
Company Stamp:
I, the undersigned, hereby declare that the residual amount of product left in the packaging ( R) has been
calculated using the following equation (please complete the table below to show this):
R = ((m2-m3) / (m1-m3)) x 100 (%)
Where:
Package size R m1 m2 m3
A test report with results of measuring the residual quantity of a rinse -off cosmetic product in the packaging
according Appendix II of this user manual is enclosed to the application.
Position held:
Date:
Company Stamp:
I, the undersigned, hereby declare that the plastic packaging is designed to facilitate effective recycling. It
avoids potential contaminants or incompatible materials that are known to impede separation or reprocessing
or to reduce the quality of recyclates. The label or sleeve, closure and, where applicable, barrier coatings do
not comprise the materials or components listed in Table 5 of the criteria document.
Pumps and aerosol containers are exempted from this requirement.
Container
Adhesives
Other
Position held:
Date:
Company Stamp:
Section 1
a). The product contains palm oil and/or palm kernel oil. YES/NO (please delete as appropriate)
b). The product contains derivatives of palm oil and/or palm kernel oil. YES/NO (please delete as appropriate)
Position held:
Date:
Company Stamp:
1. We are a member of the RSPO (Roundtable on Sustainable Palm oil) ______________ (please insert
membership number) and the total quantity of product claimed as certified (both product(s) to be EU
Ecolabelled and products making other sustainable palm oil claims such as RSPO trademark) produced during
the most recent annual trading period is within the ACOP declared and/or certificated amounts of Mass
balance (MB), Identity Preserved (IP), Segregated (SEG). The link(s) to the appropriate certificates and/or the
ACOP on the RSPO website are: _________________________________________________________(please
insert the website links)
OR
2. We can demonstrate that the palm oil and/or palm kernel oil ha s been sourced from plantations that
meet criteria for sustainable management i.e. that adhere to a set of principles and criteria that are at least
equivalent to those of the RSPO and have been developed by a multi-stakeholder organisation who have a
broad based membership including NGOs, industry and government. Please attach the necessary supporting
documentation and evidence including third party certification of amounts purchased, produced and claimed
for the most recent annual trading period.
Position held:
Date:
Company Stamp:
1. We are a member of the RSPO (Roundtable on Sustainable Palm oil) ______________ (please insert
membership number) and the total quantity of derivatives claimed as certified or supporting the production of
sustainable palm oil (both product(s) to be EU Ecolabelled and products making other sustainable palm oil
claims such as RSPO trademark) produced during the most rece nt annual trading period is within the ACOP
declared/certificated amounts of redeemed GreenPalm, Mass balance (MB), Identity Preserved (IP), Segregated
(SEG). The link(s) to the appropriate certificates and/or the ACOP on the RSPO website are:
_________________________________________________________(please insert the web site link(s))
2. We are a member of GreenPalm ______________ (please insert membership number) and the total
quantity of product claimed as supporting the production of sustainable palm oil (both product(s) to be EU
Ecolabelled and other products) produced during the most recent annual trading period is equal to the amount
of GreenPalm certificates purchased during the same trading period. I attach a copy of the annual return to
GreenPalm or if this is not yet available within three months of the end of the next annual trading period.
3. We can demonstrate that the palm oil derivatives and/or palm kernel oil derivatives have been
sourced from plantations that meet criteria for sustainable management i.e. that adhere to a set of principles
and criteria that are at least equivalent to those of the RSPO and have been developed by a multi -stakeholder
organisation who have a broad based membership including NGOs, industry and government. Please attach
the necessary supporting documentation and evidence including third party certification of amounts
purchased, produced and claimed for the most recent annual trading period.
Position held:
Date:
Company Stamp:
The product contains palm oil and/or palm kernel oil. YES/NO (please delete as appropriate).
The amount of palm/palmkernel oil (carbon content of the total carbon) is _________ (in %)
The palm oil and/or palm kernel oil is “Identity Preserved / Segregated / Mass balance / not certified” (please
delete as appropriate).
The certification scheme is RSPO / OTHER (please delete as appropriate). If “Other” the certification scheme is
………………………………………………………………………………………………………………………………………………………………………………………..
Position held:
Date:
Company Stamp:
I, the undersigned, hereby declare that the rinse-off cosmetic is fit for use (i.e. that the product fulfils the
primary and secondary functions claimed on the product label or packaging).
The products fitness for use is demonstrated by (please tick all applicable):
The information below provides details and results of the test protocol used to verify this fitness for use
(Please see Appendix IV of this User Manual for details of fitness for use testing).
Position held:
Date:
Company Stamp:
Position held
Date:
Company Stamp:
Part A and Part B of the DID list can be found on the EU Ecolabel website at:
http://ec.europa.eu/environment/ecolabel/documents/did_list/didlist_part_a_en.pdf ,
http://ec.europa.eu/environment/ecolabel/documents/did_list/didlist_part_b_en.pdf .
For substances with no data regarding aquatic toxicity and degradability, structure ana logies with similar
substances may be used to assess the TF and DF. Such structure analogies shall be approved by the
competent body granting the EU Ecolabel license. Alternatively, a worst case approach shall be applied, using
the parameters below:
* If no acceptable chronic toxicity data are found, these columns are empty. In this case, TF(chronic) is
defined as equal to TF(acute)
Documentation of ready biodegradability
The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods
detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent
ISO tests.
Interpretation of criteria:
Equivalent ISO standards could include ISO7827.
The 10 days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests
referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests
and ISO equivalents), and shall be 60 % for tests C4 -C, D, E and F (and their equivalent OECD 301 B, C, D and
F tests and ISO equivalents).
or
The reference test for anaerobic degradability shall be EN ISO 11734, ECETOC No 28 (June 1988), OECD 311
or an equivalent test method, with the requirement of 60 % ultimate degradability under anaerobic
conditions. Test methods simulating the conditions in a relevant anaerobic environment may also be used to
document that 60 % ultimate degradability has been attained under anaerobic conditions .
(1) Apply reasonable extrapolation. Use test results obtained with one raw material to extrapolate the
ultimate anaerobic degradability of structurally related surfactants. Where anaerobic
biodegradability has been confirmed for a surfactant (or a group of homologues) according to the
DID-list, it can be assumed that a similar type of surfactant is also anaerobically biodegradable
(e.g., C12-18 Alkyl ether, 1-3 EO sulphate [DID No 2009]) is anaerobically biodegradable, and a
similar anaerobic biodegradability may also be assumed for C12-15 A 6 EO sulphate). Where
anaerobic biodegradability has been confirmed for a surfactant by use of an appropriate test
method, it can be assumed that a similar type of surfactant is also anaerobically biodegradable
(e.g., literature data confirming the anaerobic biodegradability of surfactants belonging to the
group alkyl ester ammonium salts may be used as documentation for a similar anaerobic
biodegradability of other quaternary ammonium salts containing ester-linkages in the alkyl
chain(s)).
(2) Perform screening test for anaerobic degradability. If new testing is necessary, perform a screening
test by use of EN ISO 11734, ECETOC No 28 (June 1988), OECD 311 or an equivalent method.
(3) Perform low-dosage degradability test. If new testing is necessary, and in the case of experimental
problems in the screening test (e.g. inhibition due to toxicity of test substance), repeat testing by
using a low dosage of surfactant and monitor degradation by 14C measurements or chemical
analyses. Testing at low dosages may be performed by use of OECD 308 (August 2000) or an
equivalent method.
One function of the packing is to facilitate the use of the product. The restitution rate shows the
percentage of product actually consumable.
The coefficient of restitution shall be verified in accordance with the normal use of each product:
(1) If a pressure on a container is usually requested for the use of a product, this same pressure must be
applied to determine the coefficient of restitution. The emptying is considered to be completed once no
product comes out while respecting the usual conditions of use.
(2) For certain products when it’s possible, consideration should be given to a p ractice already used by many
users: At the end of use, it is possible for the user by pulsing in a water supply, to introduce a bit of water in
the container to make less thick the content so as to finish the remaining product inside. When this operation
is feasible, the coefficient of restitution should take into account a little bonus.
Residual amount (R): amount of product remaining in the container after the consumer has emptied the
container. The rate is expressed as a weight percentage and defined as follows:
2) Measurements
m1 (g)
m2 (g)
leaned: m3 (g)
3) Results
mproduct = m1-m3
mresidues = m2-m3
We deduce:
contact, with the cap in downward position. The test is considered complete when no amount of liquid will
flow after five successive pressures on the body of the primary packaging in direct contact. Neither the cap is
dismantled, nor water is introduced inside the packaging.
until
the spring has returned to its initial position prior to applying a new pressure. Repeat until no amount of
product flows from the spray after five successive pressures. Neither the cap is dismantled, nor water is
introduced inside the packaging
t: The product is removed using the index and middle fingers by rubbing the edges and the bottom of the
pot carefully but relentlessly. Neither the cap is dismantled, nor water is introduced inside the packaging
The packaging must be designed to make correct dosage easy (e.g. by ensuring that the opening at the top is
not too wide) and to ensure that at least a 90% of the product can be removed easily from the container. The
residual amount of the product in the container (R), which must be below 10%, s hall be calculated as follows:
Where:
Palm Oil and Palm Kernel Oil Derivatives are those that contain a majority of C8-C18 C-Chains.
Products with other dominant C-Chains > C18 are out of scope as they will not be derived from palm and
palm kernel oil. The scope has been limited to the major primary and secondary Oleochemicals and their
derivatives to minimize complexity.
If the C-Chain distribution is > 65 % in the range C8 – C14, the derivative shall be considered to be
produced from palm kernel oil.
If the C-Chain distribution is > 95 % in the range C16 – C18, the derivative shall be considered to be
produced from palm oil.
Other C-Chain length distributions shall be considered as derived from a blend of palm and palm
kernel oil, their raw material reference shall be palm oil.
Fatty Amines
Tertiary Amines shall be considered to be derived from palm kernel oil, reflecting their p rimary
production from Fatty Alcohol C1214. Primary Amines shall be considered in line with Fatty Acids
and Methyl esters.
Both, consumer and laboratory tests shall be conducted following the "Guidelines for the Evaluation of the
Efficacy of Cosmetic Products" available for download here:
https://www.cosmeticseurope.eu/publications-cosmetics-europe-association/guidelines.html?view=item&id=23
A consumer test shall be done in anonymous conditions; i.e. the name of the market-leading product which
will be used as reference products shall not be disclosed. For auto-evaluation tests blind use tests shall be
used as described in the "Guidelines for the Evaluation of the Efficacy of Cosmetic Products" (Chapter I.1).
A consumer test must include as minimum of 15 people. The consumers must be asked about the product’s
efficiency compared to a market-leading product. The questions to the consumers must cover at least the
following aspects:
1. How well does the product perform in comparison with the market-leading product?
2. How easy is it to apply the desired dosage of the product in comparison with the market-leading
product?
3. How easy is it to apply and rinse-off the product to/from the hair and/or skin in comparison with
the market-leading product?
At least 80 % of the consumers must be at least as satisfied with the product as with the market-leading
product.
2. If a laboratory test is employed the producer’s own test method can be accepted. The applicant must,
however, demonstrate that the test gives a measure of the product’s performance.
Both, consumer or laboratory tests shall fulfil the general requirements for all tests as described in Chapter II
and of the "Guidelines for the Evaluation of the Efficacy of Cosmetic Products" and test protocols and reports
shall contain information indicated in Chapter III and Chapter IV of this document for respective testing
methods.
18
This guidance has been taken from Appendix I of the EU Ecolabel for soaps, shampoos and hair conditioners,
available here: http://ec.europa.eu/environment/ecolabel/products-groups-and-criteria.html
Part E: Checklist
Applicant’s Checklist
This checklist summarises the documentation to be provided for each criterion. This checklist
must be completed by the applicant.
Mark when done
Documents to be submitted to the Competent Body: Included
Does not
apply
Part C: Application form
Criterion 1: Toxicity to aquatic organisms: Critical Dilution Volume (CDV)
Does not
Documents to be submitted to the Competent Body: Included apply
Declaration: Biodegradability
Criterion 3: Excluded or limited substances and mixtures
3(a) Specified excluded ingoing substances and mixtures
Does not
Documents to be submitted to the Competent Body: Included
apply
Declaration: Specified excluded ingoing substances and mixtures
3(c) Ingoing substances listed in accordance with Article 59(1) of Regulation (EC) No
1907/2006
Does not
Included
Documents to be submitted to the Competent Body: apply
Declaration: Preservatives
3(f) Colorants
Declaration: Colorants
Criterion 4: Packaging
Does not
Documents to be submitted to the Competent Body: Included
apply
Does not
Documents to be submitted to the Competent Body: Included
apply
Does not
Documents to be submitted to the Competent Body: Included
apply
Criterion 5: Sustainable sourcing of palm oil, palm kernel oil and their derivatives
Does not
Documents to be submitted to the Competent Body: Included
apply
Declaration: Sustainable sourcing of palm oil, palm kernel oil and their
derivatives Section 1, 2 and/or 3, as appropriate
Supplier Declaration: Sustainable sourcing of palm oil, palm kernel oil and
their derivatives
Criterion 6: Fitness for use