ANNEX

EU ECOLABEL CRITERIA AND ASSESSMENT AND VERIFICATION REQUIREMENTS

FRAMEWORK

CRITERIA

Criteria for awarding the EU Ecolabel to ‘rinse-off cosmetic products’:

ASSESSMENT AND VERIFICATION

a)   Requirements

The specific assessment and verification requirements are indicated for each criterion.

Where the applicant is required to provide declarations, documentation, analyses, test reports, or other evidence to show compliance with the criteria, these may originate from the applicant or his supplier(s) or both.

Where possible, the testing shall be performed by laboratories that meet the general requirements of European Standard EN ISO 17025 or equivalent.

Where appropriate, test methods other than those indicated for each criterion may be used if the competent body assessing the application accepts their equivalence.

Where appropriate, competent bodies may require supporting documentation and may carry out independent verifications.

The Appendix makes reference to the ‘Detergent Ingredient Database’ list (DID list) which contains the most widely used ingredients 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 website ( 2 ) or via the websites of the individual competent bodies.

The following information shall be provided to the competent body:

b)   Measurement thresholds

Compliance with the ecological criteria is required for all ingoing substances as defined above, with the exception of criterion 3(b) and 3(c), where preservatives, colorants and fragrances are requested to comply when their concentration equals or exceeds 0,010 % by weight in the final formulation.

EU ECOLABEL CRITERIA

Criterion 1 — Toxicity to aquatic organisms: Critical Dilution Volume (CDV)

The total CDV toxicity of the product shall not exceed the limits in Table 1:

The CDV is calculated using the following equation:

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)

Assessment and verification: 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 the Appendix).

Criterion 2 — Biodegradability

(a)   Biodegradability of surfactants

All surfactants shall be readily biodegradable under aerobic conditions and biodegradable under anaerobic conditions.

(b)   Biodegradability of organic ingoing substances

The content of all organic ingoing substances in the product that are aerobically non-biodegradable (not readily biodegradable) (aNBO) and anaerobically non-biodegradable (anNBO) shall not exceed the limits in Table 2:

Assessment and verification: 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 calculating aNBO and anNBO values is available on the EU Ecolabel website.

For both surfactants and aNBO and anNBO values, reference shall be done to the DID list. For ingoing substances which are not included in the DID list, the relevant information from literature or other sources, or appropriate test results, showing that they are aerobically and anaerobically biodegradable shall be provided as described in the Appendix.

In the absence of documentation in accordance with the above requirements, an ingoing substance other than a surfactant may be exempted from the requirement for anaerobic degradability if one of the following three alternatives is fulfilled:

Testing for adsorption/desorption may be conducted in accordance with OECD guidelines 106.

Criterion 3 — Excluded or limited substances and mixtures

(a)   Specified excluded ingoing substances and mixtures

The following ingoing substances and mixtures shall not be included in the product, neither as part of the formulation nor as part of any mixture included in the formulation:

Assessment and verification: 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.

(b)   Hazardous substances and mixtures

According to Article 6(6) of Regulation (EC) No 66/2010, the EU Ecolabel may not be awarded to any product that contains substances meeting criteria for classification with the hazard statements or risk phrases specified in Table 3 in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council ( 5 ) or Council Directive 67/548/EC ( 6 ) 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.

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).

Table 3

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.

Assessment and verification: the applicant shall demonstrate compliance with criterion 3(b) for any ingoing substance or mixture present at concentrations greater than 0,010 % in the 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 more of hazard statements or risk phrases listed in Table 3 in the form(s) and physical state(s) they are present in the product.

The following technical information related to the form(s) and physical state(s) of the ingoing substances and/or mixtures as present in the product shall be provided to support the declaration of non-classification:

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.

(c)   Ingoing substances listed in accordance with Article 59(1) of Regulation (EC) No 1907/2006

No derogation from the exclusion in Article 6(6) of Regulation (EC) No 66/2010 shall be given concerning ingoing substances identified as substances of very high concern and included in the list provided for in Article 59(1) of Regulation (EC) No 1907/2006 ( 7 ), present in the product in concentrations higher than 0,010 % (weight by weight).

Assessment and verification: reference to the list of substances identified as substances of very high concern shall be made on the date of application. The applicant shall provide the full formulation of the product to the competent body. The applicant shall also 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.

(d)   Fragrances

Assessment and verification: the applicant shall provide a signed declaration of compliance, supported by a declaration of the fragrance manufacturer, as appropriate.

(e)   Preservatives

Assessment and verification: 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.

(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.

Assessment and verification: 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.

Criterion 4 — Packaging

(a)   Primary packaging

Primary packaging shall be in direct contact with the contents.

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).

Assessment and verification: the applicant shall provide a signed declaration of compliance.

(b)   Packaging Impact Ratio (PIR)

The Packaging Impact Ratio (PIR) must be less than 0,28 g of packaging per gram of product for each of the packaging in which the product is sold. Pre-shaving products packed in metal aerosol containers are exempted from this requirement.

PIR shall be calculated (separately for each of the packaging) as follows:

PIR = (W + (Wrefill × F) + N + (Nrefill × F))/(D + (Drefill × F))

Where:

W

—

weight of packaging (primary + proportion of secondary ( 8 ), including labels)(g)

Wrefill

—

weight of refill packaging (primary + proportion of secondary (8) , including labels) (g)

N

—

weight of non-renewable + non-recycled packaging (primary + proportion of secondary (8) , including labels) (g)

Nrefill

—

weight of non-renewable and non-recycled refill packaging (primary + proportion of secondary (8) , including labels) (g)

D

—

weight of product contained in the ‘parent’ pack (g)

Drefill

—

weight of product delivered by the refill (g)

F

—

number of refills required to meet the total refillable quantity, calculated as follows: F = V × R/Vrefill Where; V — volume capacity of the parent pack (ml) Vrefill — volume capacity of the refill pack (ml) R — the refillable quantity. This is the number of times that the parent pack can be refilled. Where F is not a whole number it should be rounded up to the next whole number.

In case no refill is offered PIR shall be calculated as follows:

PIR = (W + N)/D

The manufacturer shall provide the number of foreseen refillings, or use the default values of R = 5 for plastics and R = 2 for cardboard.

Assessment and verification: the applicant shall provide the calculation of the PIR of the product. A spreadsheet for this calculation is available on the EU Ecolabel website. If the product is sold in different packaging (i.e. with different volumes), the calculation shall be submitted for each packaging size for which the EU Ecolabel shall be awarded. The applicant shall provide a signed declaration for the content of post-consumer recycled material or material from renewable origin in the packaging and a description of the refill system offered, if applicable (kinds of refills, volume). For approval of refill packaging, the applicant or retailer shall document that the refills shall be available for purchase on the market.

(c)   Design of primary packaging

The primary packaging shall be designed to make correct dosage easy (e.g. by ensuring that the opening at the top is not too wide) and to ensure that at least 90 % of the product can be removed easily from the container. The residual amount of the product in the container (R), which must be below 10 %, shall be calculated as follows:

R = ((m2 – m3)/(m1 – m3)) × 100 ( %)

Where:

m1

—

Primary packaging and product (g)

m2

—

Primary packaging and product residue in normal conditions of use (g)

m3

—

Primary packaging emptied and cleaned (g)

Assessment and verification: 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 procedure for measuring the residual quantity is described in the user manual available on the EU Ecolabel website.

(d)   Design for recycling of plastic packaging

Plastic packaging shall be designed to facilitate effective recycling by avoiding potential contaminants and incompatible materials that are known to impede separation or reprocessing or to reduce the quality of recyclate. The label or sleeve, closure and, where applicable, barrier coatings shall not comprise, either singularly or in combination the materials and components listed in Table 5.

Pumps and aerosol containers are exempted from this requirement.

Assessment and verification: 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, together with a sample of primary packaging.

Criterion 5 — Sustainable sourcing of palm oil, palm kernel oil and their derivatives

Palm oil and palm kernel oil and their derivatives used in the product must be sourced from plantations that meet criteria for sustainable management that have been developed by multi-stakeholder organisations that have a broad-based membership including NGOs, industry and government.

Assessment and verification: the applicant shall provide third-party certifications that the palm oil and palm kernel oil used in the manufacturing of the product originates from sustainably managed plantations. Certifications accepted shall include RSPO (by identity preserved, segregated or mass balance) or any equivalent scheme based on multi-stakeholder sustainable management criteria. For chemical derivatives of palm oil and palm kernel oil ( 9 ), it is acceptable to demonstrate sustainability through book and claim systems such as GreenPalm or equivalent.

Criterion 6 — Fitness for use

The product's capacity to fulfil its primary function (e.g. cleaning, conditioning) and any secondary functions claimed (e.g. anti-dandruff, colour protection) 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’ ( 10 ) and the instructions given in the user manual available on the EU Ecolabel website.

Assessment and verification: 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 and secondary functions claimed on the product label or packaging.

Criterion 7 — Information appearing on the EU Ecolabel

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

Assessment and verification: 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.

---

( 2 ) http://ec.europa.eu/environment/ecolabel/documents/did_list/didlist_part_a_en.pdf,

( 3 ) DID No is the number of the ingoing substance on the DID list.

( 4 ) 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, 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).

( 5 ) 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).

( 6 ) Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ 196, 16.8.1967, p. 1).

( 7 ) http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp

( 8 ) Proportional weight of the grouping packaging (e.g. 50 % of the total grouping packaging weight, if two products are sold together).

( 9 ) 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.

( 10 ) Available at: https://www.cosmeticseurope.eu/publications-cosmetics-europe-association/guidelines.html?view=item&id=23 and the EU Ecolabel website.