EU position on cosmetics in TTIP
Comparison between 2014 and 2015 versions
May 2014
1. Introduction
March 2015
1. Introduction
The final report of the US - EU High Level
Working Group on Jobs and Growth of
February 2013 highlights that as regards
regulatory aspects TTIP should contain, in
addition to cross-cutting disciplines and TBT
plus elements, provisions concerning
individual sectors.
The final report of the US - EU High Level
Working Group on Jobs and Growth of
February 2013 highlights that as regards
regulatory aspects TTIP should contain, in
addition to crosscutting disciplines and TBT
plus elements, provisions concerning
individual sectors.
This paper outlines the main elements of a
possible approach under TTIP to promote
regulatory convergence in the cosmetics
sector. These elements build on existing
cooperation between EU and US regulators
under ICCR (International Cooperation on
Cosmetics Regulation).
This paper outlines the main elements of a
possible approach under TTIP to promote
regulatory convergence in the cosmetics
sector. These elements build on existing
cooperation between EU and US regulators
under the International Cooperation on
Cosmetics Regulation (ICCR).
It contains preliminary ideas that can be It contains preliminary ideas that can be
complemented and refined at later stage. complemented and refined at later stage. The
TTIP could cover:
The TTIP could cover:
 mutual recognition of lists of allowed and
prohibited cosmetic substances
 collaboration in good manufacturing
practices and mutual recognition of
inspection results
 collaboration in, and regulatory
acceptance of, validated alternative test
methods to animal testing
 harmonization of test methods (based on
ISO standards) and test requirements
 approximation of labelling requirements
 strengthening the harmonization work
carried at international level under ICCR
 reinforcing regulatory cooperation on
emerging areas.
 collaboration in scientific safety assessment
methods,
 collaboration in good manufacturing
practices and mutual recognition of inspection
results
 collaboration in, and regulatory acceptance
of, validated alternative test methods to
animal testing
 harmonisation of test methods (based on
ISO standards) and test requirements
 approximation of labelling requirements
 strengthening the harmonisation work
carried out at international level under ICCR
 reinforcing regulatory cooperation on
emerging areas.
The discussions are at a relatively early stage
and therefore the specific actions that may
be decided cannot yet be determined.
But these proposed items could result in
gains not only for industry arising from
reduction of diverging requirements, but
also in:
 a wider range of cosmetics products
 more efficient testing, and
 greater international harmonisation of
cosmetics regulations and practices.
The discussions are still ongoing and therefore
the specific actions have not yet been
decided.
In any case, these proposed items could result
in gains not only for industry arising from
reduction of diverging requirements, but also
in:
 a wider range of cosmetics products
available to the consumer
 more efficient testing, and
 greater international harmonisation of
cosmetics regulations and practices.
This
could
be
achieved
without This
would
be
achieved
without
compromising the protection of public policy compromising the protection of public policy
interests such as health or animal welfare
interests such as health or animal welfare
2. Possible elements for a cosmetics annex 2. Possible elements for a cosmetics annex
in TTIP
in TTIP
2.1. Mutual recognition of lists of substances 2.1. Convergence of data requirements and
that can be used in cosmetic products scientific safety assessment methods
(positive lists) and of lists of substances that
are prohibited or restricted in cosmetic
products (negative list)
The EU Cosmetics Regulation contains lists
of substances authorized for use in cosmetic
products as colorants (listed in Annex IV), as
preservatives (listed in Annex V), and as UV
filters (listed in Annex VI). The EU Regulation
contains also lists of prohibited substances
in cosmetics (Annex II) and substances
subject to specific restrictions (Annex III).
The EU Cosmetics Regulation contains lists of
substances authorised for use in cosmetic
products as colorants (listed in Annex IV), as
preservatives (listed in Annex V), and as UV
filters (listed in Annex VI).
Both Parties could explore possibilities for
the approximation and mutual recognition
of cosmetic ingredients that are allowed in
cosmetic products.
Both Parties could endeavour to align their
data requirements and scientific safety
assessment methods for cosmetic ingredients
that must be assessed and authorised for use
in cosmetic products.
For instance, only assessed and authorised For instance, only assessed and authorised
UV filters can be used in sunscreens in the UV filters can be used in sunscreens in the EU.
EU. In the US, sunscreens are classified as In the US, sunscreens are classified as over-the
over-the counter (OTC) drugs requiring
thorough
safety
assessment
and
authorisation. Both Parties could discuss
possibilities to mutually recognize scientific
findings on the safety of UV-filters used in
sunscreens.
counter (OTC) drugs requiring also thorough
safety assessment and authorisation. Both
Parties could discuss possibilities to share
scientific findings on the safety of UV-filters
used in sunscreens.
The idea would be to facilitate the
authorisation procedure for UVfilters in one
market that are proved to be safe and
therefore allowed in the other market.
2.2.
Good
Manufacturing
Practices
(regulatory recognition of the international
standard ISO 22716 on cosmetics, and
recognition of GMP inspections for OTCs)
2.2.
Good
Manufacturing
Practices
(regulatory recognition of the international
standard ISO 22716 on cosmetics, and
recognition of GMP inspections for OTCs)
Both in the EU as in the US manufacturers
have to comply with cosmetics good
manufacturing practices. The European
standard on cosmetics GMP is fully aligned
with the international standard ISO 22716
on cosmetics GMP. FDA guidance has been
recently modified so as to align it with ISO
22716.
Both, in the EU and the US manufacturers
have to comply with cosmetics good
manufacturing practices. The European
standard on cosmetics Good Manufacturing
Practices (GMP) is fully aligned with the
international standard ISO 22716 on
cosmetics GMP.
US Food and Drug Administration (FDA)
guidance has been recently modified so as to
align it with ISO 22716.
Both Parties should agree on formally
recognising that compliance with ISO 22716
is sufficient for regulatory purposes and
work towards elimination of any differences
between own standards/guidance and ISO
22716 if at all existent.
Both Parties should agree on formally
recognising that compliance with ISO 22716
is sufficient for regulatory purposes and work
towards elimination of any differences
between own standards/guidance and ISO
22716 if at all existent.
For products classified as OTC drugs in the
US, compliance with pharma GMP is
required as well as factory inspections
carried out by FDA. In this context, the
acceptance of GMP inspections carried out
by the other Party could be explored.
For products classified as over-the counter
(OTC) drugs in the US, compliance with
pharma GMP is required as well as factory
inspections carried out by the FDA.
In this context, it would be useful to explore
whether the compliance with ISO GMP
standard for cosmetics would be sufficient
also for cosmetic products classified as OTC
drugs, or whether the results of GMP Pharma
inspections carried out by authorities in the
EU could be accepted as an alternative.
2.3. Formal regulatory acceptance of 2.3. Formal regulatory acceptance of
validated alternative tests methods to validated alternative tests methods to animal
testing
animal testing
Several alternative tests methods (ATMs) to Several alternative tests methods (ATMs) to
animal testing have been validated and animal testing have been validated and
adopted as OECD test guidelines.
adopted as OECD test guidelines.
Both Parties could agree on further fostering
the development of alternative methods for
animal testing. The overall objective is to
encourage the US to formally accept
validated test methods for regulatory
purposes for cosmetics, in particular for
products being classified as OTC drugs in the
US.
Both Parties could agree on further fostering
the development of alternative methods to
replace animal testing. The overall objective
is to promote the use of validated and OECD
accepted alternative test methods for
regulatory purposes for cosmetics.
Both sides could share scientific knowledge
on the matter including existing technical
assessments and guidance documents, and
could collaborate in the development and
implementation of the 'read across data
approach and integrated testing strategies'
that use all available information and data.
Both sides could share scientific knowledge
on the matter including existing technical
assessments and guidance documents, and
could collaborate in the development and
implementation of the 'read across data
approach and integrated testing strategies'
that use all available information and data.
2.4. Harmonization of other test methods 2.4. Harmonisation of other test methods and
of test requirements
and of test requirements
Both sides should further cooperate on the
harmonization of test methods on basis of
ISO standards (e.g. ISO 24445 – test methods
to determine the sun protecting factor)
Both sides should further cooperate on the
harmonisation of test methods on the basis
of ISO standards (e.g. ISO 24445 - test
methods to determine the sun protecting
factor).
Both sides could explore possibilities for the
approximation of requirements regarding
colour additives (EU allows those on the list
of authorized colorants without further
testing. US-FDA has to approve all colour
additives (ingredient pre-approval) and for
certain colour additives batch testing is
required).
Both sides could explore possibilities for the
approximation of requirements regarding
colour additives (The EU allows those that are
on the list of authorised colorants without
further testing. In the US for certain colour
additives batch testing is required).
The possibility to waive 'batch testing' of
OTC drugs manufactured with ingredients
considered safe by both sides (including
purity levels), could be explored (in case
existing legislation allows it). In that case,
safety compliance could be checked via
inspections on a random basis.
The possibility to waive 'batch testing' of
colorants considered safe by both sides
(including purity levels), could be explored (in
case existing legislation allows it). In that case,
safety compliance could be checked via
inspections on a random basis.
2.5. Approximation of labelling requirements 2.5. Approximation of labelling requirements
Both sides could work on further aligning
labelling requirements on the basis of the
International Nomenclature for Cosmetic
Ingredients (INCI system) in particular as
regards trivial names (e.g. acceptance of the
term aqua as alternative to water).
Both sides could work on further aligning
labelling requirements on the basis of the
International Nomenclature for Cosmetic
Ingredients (INCI system) in particular as
regards trivial names.
Other labelling requirements could be
harmonized (e.g. sunscreen protection
factor (SFP) based on common ISO test
methods) as well as the labelling of colour
ingredients (FDA using INCI names and EU
requiring colour index number).
Other labelling requirements could be
harmonized (e.g. sunscreen protection factor
(SFP) based on common ISO test methods) as
well as the labelling of colour ingredients (FDA
using INCI names and EU requiring colour
index number).
In addition, both parties could pursue In addition, both parties could pursue
collaboration in emerging issues such as collaboration in new issues such as allergen
allergen labelling. For instance, scientific labelling.
opinions underpinning regulatory decisions
on fragrances allergen labelling could be
shared.
2.6. Reinforce cooperation within ICCR
2.6. Reinforce cooperation within ICCR
Both parties could commit to further
strengthen their cooperation within ICCR
and discuss ways to implement ICCR
decisions in their jurisdictions, as well as
bringing a political commitment to reinforce
the impetus of ICCR work.
Both parties could commit to further
strengthen their cooperation within ICCR and
discuss ways to implement ICCR decisions in
their jurisdictions, as well as bringing a
political commitment to reinforce the impetus
of ICCR work.
2.7. Reinforce regulatory cooperation on 2.7. Reinforce regulatory cooperation in new
areas
emerging areas
Both Parties could cooperate in good Both Parties could cooperate in new issues
regulatory practices on emerging issues, for and consider developing disciplines and
instance with respect to nanotechnology or principles aimed at good regulatory practices
alternative test methods, and consider specific to the cosmetics sector, without
developing disciplines and principles aimed duplication of the work done in the ICCR.
at good regulatory practices specific to the
cosmetics sector, without duplication of the
work done in the ICCR