Download The Cosmetics Regulation - European Commission

The EU Cosmetics Regulation
Restrictions for Certain Substances and Special Provisions
Dr. Qasim Chaudhry
The Food and Environment Research Agency
Sand Hutton, York, United Kingdom
Member European Commission’s Scientific Committee on Consumer Safety
Member Scientific Committee of the European Food Safety Authority
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The Cosmetics Regulation:
Limitation of Certain Substances
• CMR substances
• Traces of prohibited substances
• Regulatory arrangements for nanomaterials
• Safety assessment for nanomaterials
The Cosmetics Regulation:
Limitation of certain substances
•
Annex II - list of 1328 prohibited substances
•
Annex III – list of 256 restricted substances
•
Also prohibited are:
•
certain colorants (other than those in Annex IV),
preservatives (other than those in Annex V) and
UV-filters (other than those in Annex VI);
•
substances recognised as Carcinogenic,
Mutagenic or toxic for Reproduction (CMR),
apart from exceptional cases;
•
nanomaterials – subject to a high level of
protection of human health.
The Cosmetics Regulation:
CMR classification [Regulation N° 1272/2008]
Carcinogenic
• Cat. 1A:
• Cat. 1B:
• Cat. 2:
Mutagenic
• Cat. 1A:
Known to have carcinogenic potential for humans
Presumed to have carcinogenic potential for humans
Suspected human carcinogen
Substance known to induce heritable mutations in the
germ cells of humans
• Cat. 1B:
Substance to be regarded as if it induces heritable
mutations in the germ cells of humans
• Cat. 2:
Substance which causes concern for humans owing to
the possibility that it may induce heritable mutations in
the germ cells of humans
Reproductive toxicants
• Cat. 1A:
Known human reproductive toxicant
• Cat. 1B:
Presumed human reproductive toxicant
• Cat. 2:
Suspected human reproductive toxicant
The Cosmetics Regulation:
Derogation to the Ban on CMR Substances
•
CMR2 substances
Possibility to allow where, in view of exposure and
concentration, they have been found safe for use in
cosmetic products by the SCCS, and are regulated by
the EC in the Annexes to the Regulation.
•
CMR 1A or 1B substances
Possibility, in the exceptional case that these substances
comply with food safety requirements, inter alia as a
result of their naturally occurring in food, and that no
suitable alternative substances exist, to use such
substances in cosmetic products on the condition that
such use has been found safe by the SCCS.
The Cosmetics Regulation:
Trace impurities/ contaminants
•
Presence of small quantities of a non-intended prohibited substance,
that is technically unavoidable in good manufacturing practice, is
allowed, provided that it does not cause harm to human health during
the product use.
• Annex I requires the following information concerning the impurities
and traces in the cosmetic product safety report:
• The purity of the substance and mixtures.
• In the case of traces of prohibited substances, evidence for their
technical unavoidability.
• The relevant characteristics of packaging material, in particular
purity and stability.
• There are currently not regulatory limits for most non-intended traces
• Safety is the responsibility of the manufacturer or the person under
whose responsibility the product is placed on the market.
e.g. impurities of natural or synthetic ingredients, manufacturing process, storage, migration from packaging
The Cosmetics Regulation:
Nanomaterials
•
•
•
In Europe nano cosmetic ingredients will be regulated under
the Cosmetics Regulation (EC) No 1223/2009.
The Regulation provides the first regulatory definition of a
nanomaterial*
Requires:
• cosmetic products containing nanomaterials to be notified
to the Commission 6 months prior to being placed on the
market;
• nanoscale ingredients to be labelled (name of the
ingredient, followed by ‘nano’ in brackets);
• if there are concerns over safety of a nanomaterial, the EC
will refer it to the Scientific Committee on Consumer Safety
(SCCS) for opinion.
*“nanomaterial" means an insoluble or biopersistant and intentionally manufactured material with one or more 7
external dimensions, or an internal structure, on the scale from 1 to 100 nm.”
Nanomaterials
Improved
dispersions
Stable formulations
Less use of
chemical
substances
Better control of
material properties
Potential new
properties
Increased surface
area
Greater
functionality per
equivalent mass
Enhanced uptake
of nutrients &
supplements
New
applications in
consumer
products
Effective UV
protection
Nano-sized Cosmetic Ingredients
• Colorants, antioxidants, antimicrobials, UV filters,
supplements (vitamins, minerals);
• Materials include:
• inorganic, organic
• uncoated, coated, doped
• manufactured particles, micelles, liposomes
• R&D on functional nanomaterials
• Used for better dispersibility, antimicrobial or antioxidant
properties, effective UV protection, visual clarity of
sunscreen formulations, etc;
• A growing range of products worldwide. Only a few
products currently in Europe – mainly sunscreens
containing nano UV filters.
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Nanomaterials
Safety Concerns
Nanoparticles
Inhalation
Skin application
Lung
Skin
Ingestion
Gut
?
Other cells and tissues
• Scientific evidence indicates that:
– Nanoparticles may cross membrane barriers, and reach new targets in the body;
– Nanoparticles may interact with biological entities close to the molecular level;
– Exposure to insoluble/ biopersistent nanoparticles may cause concerns over
adverse health effects.
Nanomaterial Safety
Hazard
identification
(acute, chronic)
Exposure
assessment
Routes of exposure
Local/ systemic
effects
Dose response
characterisation
Exposure
Likelihood & extent
of exposure
Hazard
Risk
Uncertainty
factors
Margins of safety
Nano-related Considerations
•
•
•
Solubility/dispersion
•
In an assay system, nanoparticles will be present as insoluble
particulates in a dispersion/suspension (not in solution);
•
Nanoparticles tend to agglomerate/aggregate due to high surface
energy. They may also stick to containers, or sediment out.
•
Maintaining a uniform concentration during the assay may be
problematic.
Surface adsorption/ binding
•
Nanoparticles may bind/adsorb various substances and moieties on the
surface – and potentially carry them into cells/tissues
•
Nanomaterials may bind with components of the test media and
interfere with the assay.
Formulation effects
•
Nanomaterials may bind with components of a formulation and this
may affect their physicochemical properties.
Nano-related Considerations
•
•
•
Metrics for toxicological measurements
•
The use of mass alone in dosimetry is not appropriate for
nanomaterials.
•
It is recommended that other parameters, such as particle number,
surface area, should also be used.
Bioavailibility – toxicokinetics
•
Nanoparticles may have a different bioavailability and biokinetic
behaviour in the body;
•
Surface characteristics, surface modification, coatings are likely to
play a major role.
•
Some nanoparticles may cross biological membranes and reach
unintended target in the body.
Surface reactions
•
Potential interaction of nanomaterials with biological entities and
processes close to the molecular level;
•
Potential surface catalysed reactions.
Cosmetic Ingredient
SCCS Guidance
(2012) on safety
assessment of
nanomaterials in
cosmetics
No
Is the ingredient or its
breakdown product a
nanomaterial?
(See Section 3 for definition)
Yes
General safety aseesment principles must be followed
(See SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation - SCCS/1416/11)
Outside the scope of nano-related safety assessment
Physicochemical
characterisation
considering nanoaspects (Section 4)
Exposure assessment
considering possible
routes (see Section 5)
Risk
Assessment
(see Section 7)
Is systemic exposure
possible?
(see Section 5)
No
Yes
Yes
No
No
Hazard identification and
dose-response
characterisation
considering nano-aspects
(see Section 6)
Any local
effects?
Physicochemical
characterisation is the material still in
the nanoscale?
Yes
Physicochemical
Characterisation
• Detailed characterisation should include:
• pristine nanoparticles as produced,
• as added to the cosmetic product,
• as present during toxicological investigations;
• Physicochemical parameters to be measured should include:
• chemical identity, chemical composition, concentration,
particle size distribution, morphology and surface
characteristics, solubility and dissolution constant, surface
area, catalytic activity, dustiness, density and pour density,
redox potential, pH, viscosity, stability in formulation and
biological media
• Measurements should be carried out using mainstream methods
- preferably more than one method – with due consideration of
the nano-aspects.
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Exposure Assessment
• Exposure assessment should consider possible translocation of
nanoparticles via all possible routes – skin, lung, or gastrointestinal
tract - mimicking anticipated use scenarios.
• Data on dermal penetration is an important
element of safety assessment;
• A large body of scientific evidence
indicates that healthy human skin is a
good barrier to particle materials,
including nanomaterials;
• A few studies have reported translocation
of certain nanomaterials through skin
(e.g. QDs, surface modified fullerenes,
ZnO), but questions remain;
• Other routes of exposure (especially
lung) are not likely to be as good a
barrier to nanoparticles as skin.
Source: skindiagram.jpg (healthy-skin-guide.com)
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Hazard Identification/
Characterisation
• All toxicological endpoints needed for safety evaluation of
a (non-nano) cosmetic ingredient should be addressed:
• Dermal/ percutaneous absorption; Toxicokinetics;
Acute toxicity; Irritation and corrosivity; Skin
sensitisation; Mutagenicity/genotoxicity; Repeated
dose toxicity;
• Where appropriate, further studies on Carcinogenicity;
Reproductive toxicity; Photo-induced toxicity;
• Additional human data (where available) .
• In vivo and in vitro methods may be used for toxicological
evaluation. However, none of the in vitro methods has so
far been validated against nanomaterials.
• Only a few elementary in silico models are currently
available.
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Safety Assessment
• Any route-to-route extrapolation should be performed
on a case-by-case, based on expert judgment of the
available scientific information;
• Where data from valid/validated tests are available and
uncertainties are not large, there may not be a reason
for applying higher margins of safety than those used
for a conventional substance;
• Where data are either insufficient or from inadequate
tests, a Risk Assessor may consider applying additional
uncertainty factors for a nanomaterial;
• Potential persistence and accumulation of nanoparticles
should also be considered.
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Nanomaterials
Current Challenges
•
Lack of validated methods for detection/
characterisation of nanomaterials – especially in
cosmetic products and in biological tissues;
•
Uncertainties and knowledge gaps in relation to
properties, behaviour and toxicological effects of
nanomaterials;
•
Lack of validated methods for assessment of
exposure via dermal, inhalation, ingestion routes;
•
Imminent ban on animal testing of cosmetic
ingredients in Europe, and the lack of validated
alternative testing methods for nanomaterials;
•
Difficulties in the use of a category approach to
safety assessment of nanomaterials;
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Nanomaterials
Guidance on Risk Assessment/ Scientific Opinions
• SCCS Guidance (2012):
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/
sccs_s_005.pdf.
• SCCS Opinion on the use of nano-ETH50 (1,3,5-Triazine, 2,4,6-tris[1,1’biphenyl]-4-yl-) as a UV filter in cosmetic products:
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/
sccs_o_070.pdf
• SCCS Opinion on the use of nano-zinc oxide as a UV filter in cosmetic
products:
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/
sccs_o_103.pdf
Summary
•
•
•
•
•
The use of CMR substances in cosmetics is prohibited
– subject to certain derogations;
Presence of non-intended trace impurities/
contaminants is only allowed subject to certain
provisions;
The use of nanomaterials will require a thorough
assessment of safety, with consideration of nanoaspects.
Guidance on safety assessment is available. First
scientific opinions on nano cosmetic ingredients are
available.
Ban on animal testing will pose a major challenge to
safety evaluation of new cosmetic ingredients especially nanomaterials.
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