DR Mark Smith Natrue

TPorgancis
Organic Innovation Days: Session II -

Looking beyond Organics
Theme 3: Use of by-products in cosmetics
Dr. Mark Smith
Director General
NATRUE AISBL
© NATRUE 2016 ·Brussels – 6th December 2016 Page 1

Presentation Outline
• Cosmetic Regulatory Framework
• ‘Natural’ & ‘Organic’ Cosmetics
• Private Standards, Guidelines

• NATRUE – organisation activities
• Organic Cosmetics – descriptions,
considerations, examples
• Future guidance? – ISO 16128
• Future Perspectives and Challenges

• Organic - Innovation potential
• Manufacturers
• Consumers
• Regulatory Framework
© NATRUE 2016 ·Brussels – 6th December 2016
EU Cosmetics Regulation
Regulation (EC) No. 1223/2009 (Cosmetics Regulation)

in force since 11 July 2013
New Regulation replaced Directive 76/768/EC
All cosmetic product are regulated by Regulation (EC)

No. 1223/2009 and their claims by Regulation (EC) No.
655/2013
⟹ Represents the main regulatory framework for finished

cosmetic products when placed on the EU market

Cosmetics: Scope and Definitions
(Article 2, Reg (EC) 1223/2009)
Cosmetic product (substance/mixture):
 for external use of the human body

 with teeth and mucous membranes of oral cavity
Exclusively or mainly to: cleanse; perfume; change

appearance; protect; keep in good condition; correct body
odours
⟹ Cosmetics have a different specific function to food
“EU organic logo cannot be used for a product which does not
satisfy the requirements set out under Regulation (EC) No
834/2007” ⟹ cosmetics (non-foods) may not use
Natural/Organic Cosmetics
in the Regulatory Framework
Fundamental baseline requirement for all cosmetics

marketed in the EU is compliance with Regulation (EC)
No. 1223/2009 (public standard) and includes:
 Finished products and ingredients

 Natural and organic or not
⟹ Without exception all cosmetics must be:

- safe; functional; effective

Natural/Organic Cosmetics
in the Regulatory Framework
‘Natural’ and ‘Organic’ Cosmetics are officially undefined
sector of a tightly regulated industry
⟹ NO (mandatory) European harmonised standard setting

criteria for natural and organic cosmetics (DG GROW)
⟹ Claims under Article 20 (EU Cosmetic Regulation)
⟹ Private, voluntary standards (e.g. NATRUE) exist to

promote a definition for ‘natural’ and ‘organic’ (in terms of
ingredients and finished products)
Why?
- Consumer benefit
- Advent of greenwashing
- Protect the sector
Natural and Organic Cosmetics: Market
European market (all natural/organic personal care
products) represents second largest (after Asia).
BUT EU leader in certified natural cosmetics

 68 % of products certified
Sector growing & competition rising
- EU total growth rate of 5-7 %

- Germany: > €1 billion in 2015; expected again in
2015; market share 7-8 % and expected 10 %
- Second biggest EU market France (3 % market
share)
- Continued growth is anticipated
NATRUE: Sector Commitment

NATRUE: Sector Commitment
Brussels-based, International Non-Profit

Association (AISBL)
Promotion and development of a strict

regulatory definition (NATRUE Standard)
of natural & organic ingredients and
cosmetics
Participation and contribution to EU

regulatory decision-making to ensure the
availability of natural & organic ingredients
NATRUE: Activities - Advocacy
Contribution to and participation in

Seat at EU Commission’s Working Group on Cosmetic
Products and sub-group claims (E01302)
CEN/TC 392 (Cosmetics - liaison organisation); liaison
officer CEN/TC 392 and CEN/TC 411 (bio-based products)
ISO TC/217/WG4 (Cosmetics - liaison organisation A)
Institutional Working Groups and Public Consultations:
Fragrance allergens; Endocrine Disruptors; CoP
Community of Practice for Better Self- and Co- Regulation
(DG CNECT: E02927); Fiscalis - Partially Denatured
Alcohol (PDA) and denaturants (DG TAXUD: E02901)
http://www.natrue.org/activities/advocacy/
NATRUE: Activities - Label
Promotion of NATRUE label as an expression of

NATRUE Standard (private)
Certify finished products (3 Levels) & raw materials*
 Only natural/derived natural ingredients*
 Not nature-identical ingredients*
Developed by advisory body: Scientific Committee

Certified by accredited, independent control bodies
Strict
Transparent
http://www.natrue.org/manufacturers/
What is Organic for a cosmetic?

All cosmetic claims are regulated by Regulation

(EC) No.655/2013
Environmental claims for non-food products for

consumers must be clear, accurate and reliable, and
in accordance with the Unfair Commercial Practices
Directive (UCPD: Directive 2005/29/EC)
Several Member States provide guidelines on

environmental claims
BUT variation: can be limited to the agricultural element not

the product; or when a significant portion or majority (≥ 95%) of
the raw materials come from organic agriculture
For private standards with verifiable criteria for

certification, the ‘norm’ to label a cosmetic product
as ‘organic’, according to its composition, is that:
• ≥ 95% of the ingredients from plant and animal

origin contained in the product must come from
controlled organic farming and/or wild
collection
• This specific % value is also representative of the

% content referenced to claim ‘organic’ in certain
countries worldwide

…some considerations:
1. Formulation (arbitrary) water cannot be organic

2. Water coming from plant origin may be considered
organic (standard dependent)
3. Synthetic substances (e.g. Annex IV [colorants], V
[preservatives] or VI [UV-filters]) may be permitted
4. Not all ingredients are available in ‘organic’ quality for
functionality and efficacy of the finished product but
may be produced from organic grade raw materials
nonetheless
5. GMO ingredients prohibited BUT GMO
enzymes/microorganisms for ingredient manufacture
may be prohibited/permitted according to the
technical criteria of the standard
⟹ ≥ 95% organic ingredients does not mean ≥ 95% of the total

product is organic
Considerations for the total product:

1. Not all private standards set a limit for % of the total product
that must be organic
2. For those that do the definition of total ‘organic’ content varies
⟹ includes ingredients from organic agriculture ± cosmetic
raw materials made using organic ingredients (differentiation)
3. Private standard criteria for total % content can range from
10%-90% to label a specific finished product as ‘organic’.
4. Some standards differentiate between cosmetic category; set
specific thresholds re: formulation considerations that
increase from a benchmark requirement
5. Some standards set horizontal organic content requirements
with lowered exceptions for specific categories

What is inside the product matters
most – Example: NATRUE Standard
Effective, high quality cosmetics cannot be

produced from nature alone ⟹ considerations
Chemically unmodified (natural/organic) substances must

be dominant
Compromises between performance and nature must be

kept to a minimum and must be transparent and
understandable
Environmental compatibility of chemically modified

substances must be guaranteed

NATRUE: Cannot be organic without
being natural - 3 certification levels
NATRUE labelled products are certified to one
of three levels:
Natural Natural Cosmetics Organic

Cosmetics with organic portion Cosmetics

Total product: Ensuring organic
Body oil Shampoo Soap
(Category 1) (Category 9) (Category 11)
[NATRUE]
Organic
cosmetics
(Level 3)
≥95% of
ingredients
from organic
agriculture
**95% **95% **95%
Body Oil Shampoo Soap

Future guidance? ISO 16128?

ISO 16128 guidelines

ISO 16128: Why?
In 2010, draft guidelines for natural and organic

cosmetic products were tabled by the conventional
cosmetic industry with the International
Standardization Organization (ISO)
Hopeful aim
Creation of harmonised technical criteria:
1. Encourage wider choice of natural/organic

ingredients in the formulation of a diverse variety
of cosmetic products to encourage innovation
2. Allowing for claims substantiation
3. Being useful to the industry at large
ISO 16128: Development
Developed by ISO Cosmetics Working Group

ISO/217/WG4 (NATRUE – liaison organisation A)
2 part (voluntary) international guideline

ISO 16128-1: Definitions for ingredients
ISO 16128-2: Criteria for ingredients [and products]
Not included: Claims and labelling, safety

(human/environmental), socio-economics (fair trade),
characteristics of packaging materials
Feb 2016: 16128-1:2016 released

16128-2 expected Q1 or Q2 (latest Q3 - Oct 2017)
NATRUE – ISO 16128: Organic?

ISO 16128-1:2016: Definitions
Topic NATRUE Standard ISO 16128-1:2016
Ingredient definitions Natural (incl. organic),  Natural*, Derived
Derived Natural (incl. Natural*, Derived Mineral*,
organic), Nat-identical Derived Organic, Non-
Natural*
ISO Natural: “Ingredients coming from GM plants can be considered as natural

ingredients in certain regions of the world”
ISO Organic: certified organic ingredients to national legislation/international

standards where applicable (physically processed)
ISO Derived Organic: No fossil fuel moieties; chemically modified cosmetic

ingredient of organic or mixed organic and natural origin; (GM)
enzymes/microorganisms may be used
ISO Non-Natural: ingredients ≥50 % of fossil fuel origin accepted

ISO 16128: Definitions and Criteria
⟹ Definitions (Pt. 1) - NO limits for: Petrochemical ingredients; ingredients
produced from GMOs that may be included in an ‘organic’ finished cosmetic as
‘natural’ ingredients; GMO processing tools or ingredients produced from them
Criteria (Pt.2) ONLY offers : Framework based on the ingredient definitions
⟹ Ability to determine the organic or organic origin content of products (±

formulation water) BUT…
⟹ NO requirement for the minimum % of organic ingredients (cf. ≥ 95%) or the %

of the total product that must be ‘organic’
⟹ NO (official) notification for when a finished product may be considered

‘organic’ e.g. based upon % content i.e. 10, 20, 50, 90% (no categorisation)
Provides the consumer only with the perception of an organic cosmetic

authenticity rather than showing transparency (reality)

What NATRUE believes…
ISO 16128 represents an overall weak benchmark

for natural/organic cosmetics
Remains highly important for NATRUE to be part

of ISO TC/217/WG4:
1. To be aware of what criteria the guidelines will
contain
2. To differentiate
3. To reveal the weaknesses to the consumer

http://www.natrue.org/news/

Future Perspectives and Challenges

Organic – innovation potential
Increased use of organic grade raw materials – production
(sustainable sourcing, direct; recyclable biomass use of organic)
Organic raw materials as starting materials for both cosmetic

ingredients (unmodified; derived products)
Processing tools – non-GM innovation for cosmetic ingredient

and derivate production (protection of term organic)
New material ingredients from – microalgae as products for

cosmetics
New material ingredient for – packaging

• Packaging from renewable raw materials; bio-plastics – building
blocks from algal products
New material ingredients for – carrier materials

• e.g. wet wipes/pads – vehicles to apply the cosmetic product
Examples…
GMO prohibition – specifically processing aids
There is no definition for an ‘organic cosmetic’ or an organic

cosmetic ingredient. Some standards ban GM processing aids;
other do not.
Issues:
• Complexity of the supply chain for cosmetics re: traceability of
the processing tool origin,
• No mandatory requirement for a manufacturer to declare the
processing aid’s origin + increased GM enzyme use
• Reliance upon vendor declaration
⟹ currently one can produce a product from organic ingredient

made using GMO enzymes
⟹ sector is open for future investment in the development of

non-GMO methods consistent with ‘organic’.
Examples…
New ingredient from – recyclable biomass,
sustainable materials development from organic
• e.g. as part of NATRUE research activities: EU-funded (Grant #262507),
Organic for Surfactants. Development new surfactants by fermentation of
waste products of organic agriculture in accordance with NATRUE criteria
“Optimise the production

of biosurfactants to create
natural cosmetics in a
sustainable way”

For Manufacturers
ONLY able to make ‘claims’ (e.g. % organic content)
BUT still….there is NO guidance for when a product is

considered organic or not
⟹ when is a product considered ‘organic’: At 20%, 50%, 70%

or 100 % organic content?
⟹ Advantage at present for the consumer remains certifiable

private standards (excluding ISO 16128 guidelines)
…yet market diversity and variability means consumer

challenges as part of informed decision-making
• Certified: varied criteria – technical;
• Non-certified – may/may not meet certified requirements;
• Bio-inspired cosmetics - greenwashed
NATRUE advocates for official definition in legislation

For Consumers
Thousands of consumers have signed-up based on
trust and confidence in private standards (e.g.
NATRUE Standard)
⟹ Informed choice possible (ingredients: non-GMO/no
petrochemicals; products); not possible with ISO
(ingredients or products)
⟹ influence of ISO 16128 guidelines may lead to

consumer confusion rather than clarity, even
potential mistrust – without fundamental consideration
of consumer expectations
NATRUE: "Exploring the territory of natural and organic

cosmetics" GfK research on consumer expectations:
http://www.natrue.org/press/resources/
Regulatory Framework
So could the future be adoption of the ISO

Guidelines nationally or territorially?
• Guidelines remain voluntary unless officially adopted
Routes for ISO Guidelines enforcement at EU level

under Article 20 of the EU Cosmetics Regulation?
⟹ ISO-Article 20:
http://www.natrue.org/press/fact-sheets/

Final thought…
A key challenge is to
maintain and
develop, not loose,
consumer trust and
confidence in natural
and organic cosmetic
products
The right to
know
The right to
choose
Thank you for
your attention!
© NATRUE 2016 ·Brussels – 6th December 2016 Slide 37

NATRUE ·
International Natural and
Organic Cosmetics Association
Floor 2 · Rue Washington 40 · 1050
Brussels Belgium
Phone +32 (0) 2 613 29 30
info@natrue.eu
www.natrue.org

Regulatory Framework
⟹ Possible routes for the ISO Guidelines to be enforced at EU

level are:
1. European Commission could issue a mandate to CEN →

would be mandatory and referenced in the EU Cosmetics
Regulation.
2. EU Member State could table the Guidelines at CEN →
would not be referenced in the EU Cosmetics Regulation;
voluntary standard as opposed to mandatory.
3. A company may unilaterally decide to refer to/certify their
products to comply with the ISO Guidelines → would lead
to consumer confusion.
⟹ ISO-Article 20: http://www.natrue.org/press/fact-sheets/

DR Mark Smith Natrue

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TPorgancis

Organic Innovation Days: Session II -

Dr. Mark Smith

© NATRUE 2016 ·Brussels – 6th December 2016 Page 1

• Private Standards, Guidelines

• Future Perspectives and Challenges

Regulation (EC) No. 1223/2009 (Cosmetics Regulation)

New Regulation replaced Directive 76/768/EC

All cosmetic product are regulated by Regulation (EC)

⟹ Represents the main regulatory framework for finished

© NATRUE 2016 ·Brussels – 6th December 2016

 for external use of the human body

Exclusively or mainly to: cleanse; perfume; change

⟹ Cosmetics have a different specific function to food

Fundamental baseline requirement for all cosmetics

 Finished products and ingredients

⟹ Without exception all cosmetics must be:

© NATRUE 2016 ·Brussels – 6th December 2016

⟹ NO (mandatory) European harmonised standard setting

⟹ Private, voluntary standards (e.g. NATRUE) exist to

BUT EU leader in certified natural cosmetics

Sector growing & competition rising

- EU total growth rate of 5-7 %

© NATRUE 2016 ·Brussels – 6th December 2016

Brussels-based, International Non-Profit

Promotion and development of a strict

Participation and contribution to EU

Contribution to and participation in

Promotion of NATRUE label as an expression of

Developed by advisory body: Scientific Committee

© NATRUE 2016 ·Brussels – 6th December 2016

All cosmetic claims are regulated by Regulation

Environmental claims for non-food products for

Several Member States provide guidelines on

BUT variation: can be limited to the agricultural element not

For private standards with verifiable criteria for

• ≥ 95% of the ingredients from plant and animal

• This specific % value is also representative of the

© NATRUE 2016 ·Brussels – 6th December 2016

1. Formulation (arbitrary) water cannot be organic

⟹ ≥ 95% organic ingredients does not mean ≥ 95% of the total

Considerations for the total product:

© NATRUE 2016 ·Brussels – 6th December 2016

Effective, high quality cosmetics cannot be

Chemically unmodified (natural/organic) substances must

Compromises between performance and nature must be

Environmental compatibility of chemically modified

© NATRUE 2016 ·Brussels – 6th December 2016

Natural Natural Cosmetics Organic

© NATRUE 2016 ·Brussels – 6th December 2016

Body Oil Shampoo Soap

© NATRUE 2016 ·Brussels – 6th December 2016

© NATRUE 2016 ·Brussels – 6th December 2016

© NATRUE 2016 ·Brussels – 6th December 2016

In 2010, draft guidelines for natural and organic

1. Encourage wider choice of natural/organic

Developed by ISO Cosmetics Working Group

2 part (voluntary) international guideline

Not included: Claims and labelling, safety

Feb 2016: 16128-1:2016 released

© NATRUE 2016 ·Brussels – 6th December 2016

ISO Natural: “Ingredients coming from GM plants can be considered as natural

ISO Organic: certified organic ingredients to national legislation/international