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 substances
R3:
Environmentally hazardous – limitation
R5:
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/dyes
R11:
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.]
Fragrances
R14:
No fragrances, aromas or fragrances from plant extracts in
products for baby or kids
R15:
Max content of allergens (26-list + R43 classified):
100 ppm in rinse-off; 10 ppm in leave-on (modified, easier)
Preservatives
R17: May not be bioaccumulative (logKow < 4 or BCF < 500)
Polymers
R20:
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
R23
R24
Solid soap: Max content of EDTA/EDTA salts (new level)
Lip and oral products: Aroma, colorants and preservative must be
approved for foodstuffs (new legislation in development)
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:
R28:
Amount of packaging vs product volume (see next slide)
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)
Marketing claims for products with organic/bio/ökologisch/ekological
ingredients
R36:
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:
glass
paper/board
plastic laminates
other materials (incl. HDPE, PP, PET etc.)
New criteria overview (VI)
Performanca:
R37: Performance/Quality , documentation (modified)
R38: Sun screens – UVA and UVB protection
R39: Toothpaste, fluorine content must follow national recommendations.
Alternatively for non-fluorine: Documentation for procection level as good
as fluorine pastes (new)
Quality & regulatory
R40-R46: Traceability, responsibility, notification by changes etc.
Recycling and marketing
R47: Relevante regler, love og/eller brancheaftaler vedr. retur
R48: 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-line
01 Application/correspondance
02 Information on product
03 Recipes/formula, Appendix 3
04 Calculations
05 Safety Data Sheets, Appendix 4, Appendix 5
06 Packaging, calculations, Appendix 6, Take-back systems
07 Performance
08 Art-work/labels, Appendix 1
09 Quality and regulatory requirements
10 Other relevant documentation
Which documentation must be
submitted for license renewal?
•
As a rule we need almost all documentation sent in:
-
•
Exceptions:
-
•
Applications and declarations
Recipes and calculations
(MSDS, see below)
Packaging specifications (type, material, weight)
Art-work/labels
(Performance, see below)
(QA procedures, see below)
MSDS: If updated and newly sent in, case-by-case assessment
QA procedures: If only about 3 years old and conditions unchanged, case-bycase 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