New criteria for Nordic Ecolabelling of Cosmetics (version 2.0)

Trine Thorup Andersen, Miljømærkning Danmark

Introduction

NEW CRITERIA overviews HOW to compile applications WHAT documentation is required

Cosmetis 2.0 – in general

• Relevant documents on www.svanen.se & www.ecolabel.dk

• Comprise all kinds of cosmetic products

• Shampoos/soaps/conditioners will get NEW license numbers

• Important changes:- Merging of criteria for Cosmetics + Shampoo/Soap/Conditioners- More environmental criteria for whole product, than based on function

(new for leave-on products)- Calculations based on long term aquatic toxicity for rinse-off.- Limitation of packaging material – also for leave-on- Stricter criteria for content of hazardous substances – health and

environment.- New declarations from raw material suppliers

New criteria overview (I)

Not allowed or limited substancesR3: Environmentally hazardous – limitationR5: Substances/groups, (new substances included)R6: Nano-materials/particles (<100 nm) not allowed (possibly OK

for TiO2 in sun screens if coming SCCS report says no cause for concern)

R3: Environmentally hazardous substances

• Maximum content of classified substances:100*cR50/53+10*cR51/53+cR52/53 ≤ 2,5%

(Typically: Fragrance substances, BHT)

• BHT regarded as classified R50/53

• Zinc compounds (R50/53) may be in zinc ointment/zinc cream up to 25%

• Data gap on biodegradation, toxicity or bioaccumulation is treated as worst case = R50/53

R5: Not allowed substances

• D4 (octamethylcyclotetrasiloxane) & D5 (decamethylcyclotetrasiloxane)

• Triclosan• Parabenes• PBT & vPvB substances from EU list

New criteria overview (II)

Biodegradation and aquatic toxicity

A) Rinse-off (sum of all organic ingredients)R8: Limit on amount of organics that do not biodegrade aerobically

(aNBO) and/or anaerobically (anNBO) (modified, stricter)R9: CDV (Critical Dilution Volume) (modified, stricter)

B) Other products (Leave-on) (min. 95 weight % of organic ingredients)R10: Biodegradability and Aquatic toxicity

R10: Biodegradability and aquatic tox. (leave-on)

• Min. 95% of organic substances (except : UV filters in sun screens and fibers in wet wipes) must be either:

readily biodegradable (OECD 301, OECD 310) or

lowest EC/LC50 > 10 mg/l and not bioavailable (MW > 700 g/mol) or

lowest EC/LC50 > 10 mg/l and not bioaccumulative(logKow > 4 or BCF > 500) or

lowest EC/LC50 > 10 mg/l and inherently biodegradable (OECD 302)

New criteria overview (III)Colorants/dyesR11: May not be bioaccumulative (logKow < 4 or BCF < 500) OR

must be approved in foodstuffs.R12: Max content of metals [Ba, Pb, Hg, Cd, Bi, Cr]: 10 ppm

[Covered by new Regulation but no lower limit for impurities.]

FragrancesR14: No fragrances, aromas or fragrances from plant extracts in

products for baby or kidsR15: Max content of allergens (26-list + R43 classified):

100 ppm in rinse-off; 10 ppm in leave-on (modified, easier)

PreservativesR17: May not be bioaccumulative (logKow < 4 or BCF < 500)

PolymersR20: Max content 100 ppm of af harmful monomers in fresh polymer

(CMR, sensitizing, hormone disrupting, R50/53, R51/53)

R14:Fragrances and baby/kids products

• Fragrances/aromas/fragrance substances in plant extracts may not be added to products for infants/baby/junior/kids

= Products marketed to people aged 0-12 years.

Natural based ingredients, non-scenting, not for fragrance/aromatic purpose such as Aloe Vera, neutral oils/fats, butters etc. may still be used. Case-by-case assessment.

New criteria overview (IV)

Requirements for specific products:

R22 Solid soap: Max content of EDTA/EDTA salts (new level)R23 Lip and oral products: Aroma, colorants and preservative must

be approved for foodstuffs (new legislation in development)R24 Hair dyes: Lawson may not be used. Dyestuffs assessed as

sensitizing by SCCS may not be used (modified)

New criteria overview (V)

Packaging (primary packaging only):

R27: Amount of packaging vs product volume (see next slide)R28: Type of material: mono-material (plastic, metal, glass) parts separable

R30: Metal cans (aerolsols) allowed for hair styling and shaving foam only

R31: Paper/board, not chlorine gas bleached

R32: Dosing facility assure non-overdosing, max dose for pumps and dispensers (soaps)R36: Marketing claims for products with organic/bio/ökologisch/ekological ingredients

R27: Packaging amount vs product volume

• Packaging shall overhold calculation in the criteria. Only 2 layers of packaging is allowed (e.g. can in box, tube in box).

• Leaflets are allowed but must be included.

• Type in parameters in ready-to-use calculation sheet! (product volume vs weight and recycled content of packaging components)

Note: Different materials are weighted based on their impact from an LCA view: glasspaper/boardplastic laminatesother materials (incl. HDPE, PP, PET etc.)

New criteria overview (VI)

Performanca:R37: Performance/Quality , documentation (modified)R38: Sun screens – UVA and UVB protectionR39: Toothpaste, fluorine content must follow national recommendations. Alternatively for non-fluorine:

Documentation for procection level as good as fluorine pastes (new)

Quality & regulatoryR40-R46: Traceability, responsibility, notification by changes etc.

Recycling and marketingR47: Relevante regler, love og/eller brancheaftaler vedr. returR48: Markedsføring skal ske i hht Nordisk Miljømærknings regler

R37: Performance

The performance and quality of the product must be satisfactory. This can be demonstrated through relevant testing. Testing must at a minimum test the characteristics with which the product is marketed. If there is a recognised test method (see for example R38 for sunscreen products), this shall be used. For other products, a test could be the manufacturer’s internal quality test, a consumer test with test group of 10 or more independent individuals, or a comparative test relating to a similar product, e.g. a triangle test.

The Colipa (European Cosmetics Association) guidelines on Efficacy Evaluation of Cosmetic Products must be observed.

Description of test, including an account of chosen testing methods and test results. If a consumer test is used a copy of completed and signed test reports is to be supplied. This report shall include a description of the test group, the number of participants and a summary of test results.

Appendix 3 or equivalent declaration duly completed and signed.

Declarations from raw material suppliers, Appendix 4

N.B. – Declarations (new): For documentation of requirement on ingredient classification and absence of certain substances, Appendix 4 must be completed by the raw material suppliers.

This applies for all suppliers and raw materials!

How to make the dossier

• We prefer electronic documents

• Example of dossier out-line01 Application/correspondance02 Information on product03 Recipes/formula, Appendix 304 Calculations05 Safety Data Sheets, Appendix 4, Appendix 506 Packaging, calculations, Appendix 6, Take-back systems07 Performance08 Art-work/labels, Appendix 109 Quality and regulatory requirements10 Other relevant documentation

Which documentation must be submitted for license renewal?• As a rule we need almost all documentation sent in:

- Applications and declarations- Recipes and calculations- (MSDS, see below)- Packaging specifications (type, material, weight)- Art-work/labels - (Performance, see below)- (QA procedures, see below)

• Exceptions:- MSDS: If updated and newly sent in, case-by-case assessment- QA procedures: If only about 3 years old and conditions unchanged, case-by-case

assessment- Performance: If rather newly sent in and product unchanged, case-by-case assessment

• Packaging samples could be submitted if we specifically ask for them