Saatja: Elen Ohov </O=JM/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=D1F60C90FE9D4133827E2E90805100FD-ELEN OHOV>
Saaja:
[email protected]
Teema: EL kosmeetikatoodete määruse avalik konsultatsioon - Eesti vastused kirjalikuks kooskõlastamiseks (10.06 tähtaeg)
Tere,
Esitame KOKile kirjaliku menetluse teel kooskõlastamiseks Eesti seisukohad EL kosmeetikatoodete määruse läbivaatamisega seotud avalikule konsultatsioonile vastamiseks (vastamise tähtaeg 21.juuni). Vastustes tugineme 10.12.2020 VV kinnitatud seisukohtadele ELi kemikaalistrateegia kohta ja 6.04.2022 KOKis heakskiidetud REACH-määruse avaliku konsultatsiooni seisukohtadele.
Vaikimisi kooskõlastamise tähtaeg on 10.juuni.
Tervitades
Elen Ohov
nõunik | Eurokoordinatsiooni ja välissuhete osak.
+372 626 9241 |
[email protected]
Sotsiaalministeerium
Suur-Ameerika 1 | 10122 Tallinn
626 9301 | http://www.sm.ee
Draft ID: 4d58798e-51c7-44c4-86cc-48df34075604
Date: 06/06/2022 08:37:08
Public consultation for the targeted revision of
the Cosmetic Products Regulation
Fields marked with * are mandatory.
Introduction
The Cosmetic Products Regulation is the main regulatory framework for finished cosmetic products placed
on the EU market. It lays down the rules applicable to all cosmetic products to ensure a well-functioning
internal market and to provide a high level of public health protection.
The Chemicals Strategy for Sustainability (hereinafter the Strategy) outlines the European Commission’s
strategy to better protect the public and the environment against hazardous chemicals and encourage
innovation to develop safe and sustainable alternatives in the framework of the EU Green Deal.
The Strategy fully recognises the fundamental role of chemicals for human wellbeing and for the green and
digital transition of European economy and society. At the same time, it acknowledges the urgent need to
address the health and environmental challenges caused by the most harmful chemicals. In this spirit, the
Strategy sets out specific measures to make chemicals safe and sustainable by design and to ensure that
chemicals can deliver all their benefits without harming the planet and current and future generations.
The Strategy recognises the need for a targeted revision of the Cosmetic Products Regulation to achieve
its objectives by overcoming a number of identified problems. To address these problems, the Commission
is considering a range of potential measures:
an automatic ban of the most harmful chemicals (the ’generic approach to risk management’),
allowing their use only where it is proven to be essential for society;
a new measure to take into account the combination effects from simultaneous or subsequent
exposure to chemicals from different sources;
a review of the definition of nanomaterial;
improving labelling information on cosmetic products, and;
streamlining scientific assessments of cosmetic products by reassigning the work of the Scientific
Committee on Consumer Safety (SCCS) to the European Chemicals Agency (ECHA).
The overall objective of the targeted revision is to ensure that the Cosmetic Products Regulation reflects
the Commission’s ambitions on innovation for safe and sustainable chemicals and a high level of protection
of health and the environment, while preserving the internal market, as provided for in the Chemicals
Strategy for Sustainability.
In this questionnaire, we ask a series of general questions and we welcome your views and feedback. We
1
also include a set of additional ’expert’ questions to cover more technical points of the Cosmetic Products
Regulation that require prior knowledge and expertise. The questionnaire will ask you questions based on
your answer to question 0.
The Commission will run a number of separate ‘targeted’ stakeholder consultations in parallel with this
public consultation to seek more detailed, technical information on the potential changes to the Cosmetic
Products Regulation.
About you
* Language of my contribution
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* I am giving my contribution as
2
Academic/research institution
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Company/business organisation
Consumer organisation
EU citizen
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Other
* First name
Gerlin
* Surname
KALLAS
* Email (this won't be published)
[email protected]
* Scope
International
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* Level of governance
Parliament
Authority
Agency
* Organisation name
255 character(s) maximum
3
Sotsiaalministeerium
* Organisation size
Micro (1 to 9 employees)
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Medium (50 to 249 employees)
Large (250 or more)
Transparency register number
255 character(s) maximum
Check if your organisation is on the transparency register. It's a voluntary database for organisations seeking to
influence EU decision-making.
* Country of origin
Please add your country of origin, or that of your organisation.
Afghanistan Djibouti Libya Saint Martin
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Miquelon
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Republic and the
Grenadines
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Príncipe
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Barbuda
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4
Austria Finland Mauritius Slovenia
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and Antarctic and the South
Lands Sandwich
Islands
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Ocean Territory
British Virgin Guyana Niger The Gambia
Islands
Brunei Haiti Nigeria Timor-Leste
Bulgaria Heard Island and Niue Togo
McDonald Islands
Burkina Faso Honduras Norfolk Island Tokelau
Burundi Hong Kong Northern Tonga
Mariana Islands
5
Cambodia Hungary North Korea Trinidad and
Tobago
Cameroon Iceland North Macedonia Tunisia
Canada India Norway Turkey
Cape Verde Indonesia Oman Turkmenistan
Cayman Islands Iran Pakistan Turks and
Caicos Islands
Central African Iraq Palau Tuvalu
Republic
Chad Ireland Palestine Uganda
Chile Isle of Man Panama Ukraine
China Israel Papua New United Arab
Guinea Emirates
Christmas Island Italy Paraguay United Kingdom
Clipperton Jamaica Peru United States
Cocos (Keeling) Japan Philippines United States
Islands Minor Outlying
Islands
Colombia Jersey Pitcairn Islands Uruguay
Comoros Jordan Poland US Virgin Islands
Congo Kazakhstan Portugal Uzbekistan
Cook Islands Kenya Puerto Rico Vanuatu
Costa Rica Kiribati Qatar Vatican City
Côte d’Ivoire Kosovo Réunion Venezuela
Croatia Kuwait Romania Vietnam
Cuba Kyrgyzstan Russia Wallis and
Futuna
Curaçao Laos Rwanda Western Sahara
Cyprus Latvia Saint Barthélemy Yemen
Czechia Lebanon Saint Helena Zambia
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Tristan da Cunha
Democratic Lesotho Saint Kitts and Zimbabwe
Republic of the Nevis
Congo
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Denmark Liberia Saint Lucia
The Commission will publish all contributions to this public consultation. You can choose whether you
would prefer to have your details published or to remain anonymous when your contribution is published. Fo
r the purpose of transparency, the type of respondent (for example, ‘business association,
‘consumer association’, ‘EU citizen’) country of origin, organisation name and size, and its
transparency register number, are always published. Your e-mail address will never be published.
Opt in to select the privacy option that best suits you. Privacy options default based on the type of
respondent selected
* Contribution publication privacy settings
The Commission will publish the responses to this public consultation. You can choose whether you would like
your details to be made public or to remain anonymous.
Anonymous
Only organisation details are published: The type of respondent that you
responded to this consultation as, the name of the organisation on whose
behalf you reply as well as its transparency number, its size, its country of
origin and your contribution will be published as received. Your name will not
be published. Please do not include any personal data in the contribution itself
if you want to remain anonymous.
Public
Organisation details and respondent details are published: The type of
respondent that you responded to this consultation as, the name of the
organisation on whose behalf you reply as well as its transparency number, its
size, its country of origin and your contribution will be published. Your name
will also be published.
I agree with the personal data protection provisions
Question 0 - What is your level of knowledge of the Cosmetic Products
Regulation?
For this consultation, there are a set of ‘general’ questions for respondents with no
or little knowledge of the Cosmetic Products Regulation, and an additional set of
‘expert’ questions for respondents with good or excellent knowledge of this
Regulation. ‘Expert’ questions will only appear if the corresponding reply has been
selected.
General
General + expert
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1. Generic approach to risk management
The Chemicals Strategy for Sustainability announced the proposal to extend the generic approach to risk
management, which means that the most harmful chemicals will be banned in cosmetic products by
default, while allowing limited exemptions under conditions clearly defined in law.
The proposal is to extend the general approach under the Cosmetic Products Regulation to cover
chemicals that are endocrine disruptors for human health, affect the immune, neurological or respiratory
systems or are toxic to a specific organ, based on their hazard and on generic exposure considerations.
This differs from a specific approach to risk management requiring proof of an unacceptable risk for each
use before restricting use.
Question 1. Would you buy cosmetic products that contain the following
substances knowing the product itself is safe, on a scale from 1 (opposed) to
5 (strongly in favour)?
(Single answer per row)
5
1 (strongly Don't
2 3 4
(opposed) in know
favour)
Substances that are carcinogenic, mutagenic
or toxic for reproduction (CMRs)
Substances that are disruptive to the endocrine
system (endocrine disruptors)
Chemicals affecting the immune system
Chemicals affecting the neurological system
Chemicals affecting the respiratory system
Chemicals toxic to a specific organ
Substances in cosmetics that are carcinogenic, mutagenic or toxic for reproduction
The Cosmetic Products Regulation already has provisions prohibiting or restricting (under certain
conditions) the use of these substances following the generic approach to risk management (i.e. Article 15).
Chemicals that have adverse effects on the environment, including endocrine disruptors for the
environment and those that are persistent and bioaccumulative and toxic, are subject to regulatory
measures under REACH.
Question 1a. To what extent do you agree with the following statements
regarding existing (or missing) provisions on substances that are
carcinogenic, mutagenic or toxic for reproduction (CMR substances) (Article
15) in the Cosmetic Products Regulation?
(Single answer per row)
8
Neither
Strongly agree Strongly Don't
Agree Disagree
agree nor disagree know
disagree
The current exemption criteria for
CMR Category 2 substances do
not need to be changed
The current provisions regarding
CMR Category 1A/B substances
should be extended to CMR2
substances as well
The current provisions regarding
CMRs should be extended to
include the adverse effects on or
via lactation
The following exemption criteria
for CMR Category1A/B
substances should be revised:
a) compliance with the food
safety requirements as defined in
Regulation (EC) No 178/2002
b) lack of suitable alternatives
c) application is made for a
particular use of the product
category with a known exposure
d) use evaluated as safe by the
SCCS in cosmetic products
(exposure to these products and
taking into consideration the
overall exposure from other
sources, and specific vulnerable
population groups)
e) a new criterion should be
added to only grant an
exemption for uses proven to be
essential for society
Endocrine disruptors
Endocrine disruptors are chemical substances that alter the functioning of the endocrine system and
negatively affect the health of humans and animals. They may either be of synthetic or natural origin.
Exposure to endocrine disruptors can occur from different sources, such as residues of pesticides or
consumer products used or present in our daily life.
The Cosmetic Products Regulation does not have any explicit provisions prohibiting or restricting the use of
9
endocrine disruptors as it does for substances that are carcinogenic, mutagenic or toxic for reproduction.
According to the objectives of the Chemicals Strategy, the generic approach to risk management should
also be extended to endocrine disruptors and they should be banned as soon as they are classified. As
such, in the process of revising the CLP Regulation, the Commission is examining whether to include new
hazard classes for endocrine disruptors. One option is to bring in two hazard classes for endocrine
disruptors (one for human health and one for environment), with categories for each class (‘category 1:
Known or presumed endocrine disruptors’ and ‘category 2: Suspected endocrine disruptors’).
The generic approach to risk management under the Cosmetic Products Regulation will cover endocrine
disruptors for human health, whereas the process under REACH is envisaged to cover endocrine
disruptors for the environment.
Question 1b. To what extent do you agree with the following statements
regarding the extension of the generic approach to risk management to
endocrine disruptors for human health in cosmetics?
(Single answer per row)
Neither
Strongly agree Strongly Don't
Agree Disagree
agree nor disagree know
disagree
Explicit provisions are needed for
both ‘known/presumed’
(Category 1) and ‘suspected’
(Category2) endocrine disruptors
for human health
Explicit provisions are needed
only for ‘known/presumed’
(Category 1) endocrine
disruptors for human health
Explicit provisions are needed
only for ‘suspected’ (Category 2)
endocrine disruptors for human
health
Future provisions should be
aligned with the generic
approach to risk management on
CMRs in cosmetics. Therefore,
the following exemption criteria
should be added:
a) compliance with the food
safety requirements set out in
Regulation (EC) No 178/2002
b) lack of suitable alternatives
10
c) application is made for a
particular use of the product
category with a known exposure
d) use evaluated as safe by the
SCCS in cosmetic products
(exposure to these products and
taking into consideration the
overall exposure from other
sources, and specific vulnerable
population groups)
e) a new criterion should be
added to only grant an
exemption for uses proven to be
essential for society
Chemicals in cosmetics that affect the immune, neurological or respiratory systems and chemicals toxic to
a specific organ
The Chemicals Strategy also announces the proposal to extend the generic approach to risk management
to chemicals affecting the immune, neurological or respiratory systems and chemicals that are toxic to a
specific organ.
To date, these substances can be restricted in the Cosmetic Products Regulation only when there is a
potential risk to public health.
Question 1c. To what extent do you agree with the following statements
regarding the extension of the generic approach to risk management on
chemicals affecting the immune, neurological or respiratory systems and
chemicals toxic to a specific organ in the Cosmetic Products Regulation?
(Single answer per row)
Neither
Don’
Strongly agree Strongly
Agree Disagree t
agree nor disagree
know
disagree
Explicit provisions are not needed
as these substances are already
adequately regulated when there
is a potential risk to human health
Explicit provisions are needed to
extend the generic approach to
risk management to chemicals
affecting the immune system
11
Explicit provisions are needed to
extend the generic approach to
risk management to chemicals
affecting the neurological system
Explicit provisions are needed to
extend the generic approach to
risk management to chemicals
affecting the respiratory system
Explicit provisions are needed to
extend the generic approach to
risk management to chemicals
toxic to a specific organ
Future provisions should be
aligned with the generic approach
to risk management on CMRs.
Therefore, the following
exemption criteria should be
added:
a) compliance with the food
safety requirements set out in
Regulation (EC) No 178/2002
b) lack of suitable alternatives
c) application is made for a
particular use of the product
category with a known exposure
d) use evaluated as safe by the
SCCS in cosmetic products
(exposure to these products and
taking into consideration the
overall exposure from other
sources, and specific vulnerable
population groups)
e) a new criterion should be
added to only grant an exemption
for uses proven to be essential
for society
Question 1d. Please indicate the expected impacts of extending the generic
approach to risk management to the use in cosmetic products of endocrine
disruptors and chemicals affecting the immune, neurological or respiratory
systems and chemicals toxic to a specific organ on the following. Use a scale
from 1 (strongly negative i.e. detrimental) to 5 (strongly positive, i.e.
beneficial):
(Single answer per row)
12
1 5 Don’
(strongly 2 3 4 (strongly t
negative) positive) know
As regards endocrine disruptors:
Administrative burden on cosmetics companies,
e.g. compliance costs
Impacts on a cosmetics company product
portfolio, e.g. extent of reformulation requested
Resources of national public authorities
Human health protection (e.g. impacts on
professional workers such as hairdressers,
beauticians) and consumers)
Competitiveness of EU cosmetics companies
Innovation and research on cosmetic ingredients
Impacts on consumers in terms of price of
cosmetic products
Other (please specify)
As regards chemicals affecting the immune
system:
Administrative burden on cosmetics companies,
e.g. compliance costs
Impacts on a cosmetics company product
portfolio, e.g. extent of reformulation requested
Resources of national public authorities
Human health protection (e.g. impacts on
professional workers such as hairdressers,
beauticians) and consumers)
Competitiveness of EU cosmetics companies
Innovation and research on cosmetic ingredients
Impacts on consumers in terms of price of
cosmetic products
Other (please specify)
As regards chemicals affecting the
neurological system:
Administrative burden on cosmetics companies,
e.g. compliance costs
Impacts on a cosmetics company product
portfolio, e.g. extent of reformulation requested
Resources of national public authorities
13
Human health protection (e.g. impacts on
professional workers such as hairdressers,
beauticians) and consumers)
Competitiveness of EU cosmetics companies
Innovation and research on cosmetic ingredients
Impacts on consumers in terms of price of
cosmetic products
Other (please specify)
As regards chemicals affecting the
respiratory system: Administrative burden on
cosmetics companies, e.g. compliance costs
Impacts on a cosmetics company product
portfolio, e.g. extent of reformulation requested
Resources of national public authorities
Human health protection (e.g. impacts on
professional workers such as hairdressers,
beauticians) and consumers)
Competitiveness of EU cosmetics companies
Innovation and research on cosmetic ingredients
Impacts on consumers in terms of price of
cosmetic products
Other (please specify)
As regards chemicals affecting the chemicals
toxic to a specific organ:
Administrative burden on cosmetics companies,
e.g. compliance costs
Impacts on a cosmetics company product
portfolio, e.g. extent of reformulation requested
Resources of national public authorities
Human health protection (e.g. impacts on
professional workers such as hairdressers,
beauticians) and consumers)
Competitiveness of EU cosmetics companies
Innovation and research on cosmetic ingredients
Impacts on consumers in terms of price of
cosmetic products
Other (please specify)
14
If ‘other’, please explain (500 words maximum)
4000 character(s) maximum
2. Granting exemptions for the use of the most harmful chemicals in cosmetics
The Chemicals Strategy for Sustainability outlines a number of commitments to tackle chemical pollution
and exposure to better protect the public and the environment, and to step up innovation of safe and
sustainable chemicals and products for the green transition. Extending the generic approach to risk
management will ensure that consumers, vulnerable groups and the natural environment are more
consistently protected, while still allowing for the use of the most harmful chemicals where this is proven to
be essential for society.
The criteria for essential use must be properly defined ‘to ensure that the most harmful chemicals are only
allowed if their use is necessary for health, safety or is critical for the functioning of society and if there are
no alternatives that are acceptable from the standpoint of environment and health’.
This means that the essential use concept would allow the use of most harmful substances only
exceptionally and under very strict conditions.
Question 2. To what extent do you agree with the following statements?
It should be possible to continue using the most harmful substances in cosmetic
products provided that:
Neither
Don’
Strongly agree Strongly
Agree Disagree t
agree nor disagree
know
disagree
a) their use is safe for human
health (as evaluated by an
independent scientific committee)
b) their use is safe for human
health and no suitable
alternatives are available
c) their use is safe for human
health, no suitable alternatives
are available and only if their use
in cosmetics is necessary for
health, safety or critical for the
functioning of society
Should not be allowed under any
circumstances
15
Question 2a. To what extent do you agree that the essential use concept,
which allows exemptions for use of the most harmful substances in
cosmetics, is needed in the Cosmetic Products Regulation as part of the
application of the Generic Approach to Risk management (GRA)?
(Single answer)
Strongly agree
Agree
Neither agree nor disagree
Disagree
Strongly disagree
Don’t know
Other (please specify below)
Question 2b. Please indicate the expected impacts of bringing in the
essential use concept to manage the most harmful substances in cosmetics
products, on a scale from 1 (strongly negative i.e. detrimental) to 5 (strongly
positive, i.e. beneficial):
1 5 Don’
(strongly 2 3 4 (strongly t
negative) positive) know
Administrative burden on cosmetics companies,
e.g. compliance costs
Impacts on a cosmetics company product
portfolio, e.g. extent of reformulation requested
Resources of national public authorities
Human health protection (e.g. impacts on
professional workers such as hairdressers,
beauticians and consumers)
Competitiveness of EU cosmetics companies
Innovation and research on cosmetic ingredients
Impacts on consumers in terms of price of
cosmetic products
Other (please specify below)
If ‘other’, please explain (500 words maximum)
4000 character(s) maximum
16
3. Combination effects from simultaneous exposure to chemicals from different
sources
Over the years, a number of reports have highlighted that chemical substances may cause adverse effects
to human health when they are combined, even if the individual substances are present at concentrations
that are considered safe. Most pieces of chemicals legislation consider intentional/commercial mixtures and
require a risk assessment of such mixtures. However, requirements to take into account consumer
exposure to a number of chemical substances from multiple sources (or “unintentional mixtures”) are
broadly lacking from legislation.
The Chemicals Strategy for Sustainability therefore announces that, in order to adequately address the
combination effects of chemicals in unintentional mixtures, legal requirements need to be laid down
consistently to take effective and systematic account of the risks from simultaneous exposure to multiple
chemicals across chemicals-related policy areas.
Question 3. Consumers are exposed on a daily basis to a number of chemical
substances (in soaps and detergents, paints and contaminants in food, water
and air).
Do you think unintentional co-exposure to chemicals from different sources
should be considered when cosmetic products are being assessed for their
safety?
(Single answer)
Strongly agree
Agree
Neither agree nor disagree
Disagree
Strongly disagree
Don’t know
According to the Commission’s Implementing Decision 2013/674/EU ‘Guidelines on cosmetic product
safety assessments’, the safety assessors of finished cosmetic products consider the potential combination
effects of ingredients used in cosmetic products (intentional mixtures) taking into account the identified
normal use and the reasonably foreseeable use. However, there is no obligation to consider combination
effects for chemicals present in cosmetics with other substances that the consumer is exposed to, including
substances present in other cosmetic products or from other sources, for example in of paints or
contaminants in food and water.
17
As it is currently not realistic or economically feasible to specifically assess and regulate the almost infinite
number of possible combinations of chemicals, a practical approach for the cosmetics safety assessment to
evaluate the simultaneous exposure to multiple chemicals would be to use the mixtures assessment factor
(MAF) approach.
The mixtures assessment factor (MAF) is a pragmatic approach to manage unknown risks since a safety
assessor is not aware of all substances that could also affect human health. In practice, when applying
MAF, exposure levels that are considered sufficiently safe for single chemicals are reduced by a certain
factor to safeguard against the risk from the combined exposure to multiple chemical substances.
Question 3a. If the mixture assessment factor approach were brought into the
safety assessment of cosmetic products, do you think it should apply to:
(Single answer)
all substances used in cosmetics (i.e. addressing non-intentional co-exposure
to all substances used in cosmetics with any other substance that the
consumer may be exposed to)
only substances that are carcinogenic, mutagenic and toxic for reproduction,
endocrine disruptors, chemicals affecting the immune, neurological or
respiratory systems and chemicals toxic to a specific organ (i.e. addressing
non-intentional co-exposure of only these substances used in cosmetics with
any other substances that the consumer may be exposed to)
Don’t know
Question 3b. To what extent do you agree with the following statements
regarding the application of a mixture assessment factor (MAF) in the safety
assessment of cosmetic ingredients?
Neither
Don’
Strongly agree Strongly
Agree Disagree t
agree nor disagree
know
disagree
A single MAF should be used for
all ingredients used in cosmetics
Different MAFs should be used
based on substance properties (e.
g. toxicological properties, mode
of action, chemical structure or
physicochemical properties)
Different MAFs should be applied
for professional workers (e.g.
hairdressers, beauticians, etc.)
and consumers
A MAF should be used during the
exposure assessment
18
A MAF should be used during the
dose-response assessment
A MAF should be used during the
risk characterisation / margin of
safety assessment (MoS)
Question 3c. To what extent do you agree that the application of (a) mixture
assessment factor(s) in the safety assessment of cosmetic ingredients will
lead to the following:
(Single answer per row)
Neither Don’
Strongly Strongly
Agree agree nor Disagree t
agree disagree
disagree know
Greater consumer protection
Greater protection of
professional workers (e.g.
hairdressers, beauticians)
Increased competitiveness of
EU cosmetics companies
More innovation and research
into cosmetic ingredients
Economic benefits for industry
A higher administrative burden
on business, e.g. compliance
costs
A higher administrative burden
on public authorities
Increased reformulations for
cosmetic products
Higher prices of cosmetic
products
Other (please specify)
4 A review of the definition of nanomaterial
Nanomaterials are characterised by their tiny size, measured in nanometres (i.e. one millionth of a
millimetre), which make them impossible to be observed by the naked eye. They are present in nature,
such as in beach sand, but they are also manufactured and added to consumer products since they exhibit
or can provide novel characteristics (such as greater strength, chemical reactivity or conductivity, etc.)
compared to the same material without nanoscale features.
19
The Cosmetic Products Regulation defines nanomaterials as ‘an insoluble or biopersistant and intentionally
manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to
100 nm’. In addition, it includes nanomaterial-specific provisions (including labelling) to ensure they are
adequately assessed for safety if used as ingredients. In 2011, the Commission adopted a recommendation
on the definition of nanomaterials, to be used as a horizontal definition, which was explicitly tailored to
facilitate consistent and efficient regulatory application. As such, it is applied in several EU regulations
including the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),
the Biocidal Product Regulation (BPR) and the Medical Devices Regulation. This recommendation has just
been reviewed.
Question 4. To what extent do you agree with the following statements?
(Single answer per row)
Neither
Don’
Strongly agree Strongly
Agree Disagree t
agree nor disagree
know
disagree
The definition of nanomaterial in
the Cosmetic Products
Regulation should be updated
The definition of nanomaterial in
the Cosmetic Products
Regulation should be consistent
with the definition applicable to
multiple sectors (i.e. a cross-
sectoral definition)
According to the Cosmetic Products Regulation, ‘nanomaterial’ means an insoluble or biopersistent and
intentionally manufactured material with one or more external dimensions, or an internal structure, on the
scale from 1 to 100 nm. A Commission Recommendation of 2011 provides a horizontal definition of
nanomaterials, stating that ‘natural, incidental or manufactured material containing particles, in an unbound
state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number
size distribution, one or more external dimensions is in the size range 1 nm-100 nm.’
Based on a Report/Review on the use of nanomaterials in cosmetics, there are differences between the
definition of nanomaterial in the Cosmetic Products Regulation and in the Commission Recommendation of
2011. This creates some discrepancies across different sectors concerning the classification of materials as
nanomaterials. For example, the cross-sectoral Regulation on Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH) applies the 2011 Recommendation and hence some materials are
considered nanomaterials under REACH and not under the Cosmetics Regulation, and vice versa. This
may create questions and inconsistent approaches amongst competent authorities and businesses across
the single market.
As planned in the Chemicals Strategy for Sustainability, Recommendation 2011/696/EU on the (horizontal)
definition of nanomaterial has just been reviewed, following an extensive stakeholder consultation. The
Commission is in process of revising the Recommendation with minor changes. Since the first
Recommendation was adopted in 2011, the Commission has been committed to ensuring consistency
between nanomaterial definitions across EU regulations through the use of the Recommendation.
20
Question 4a. To what extent do you agree with the following statements?
The current nanomaterial definition under the Cosmetic Products Regulation is:
Don’
Strongly Neither agree Strongly
Agree Disagree t
agree nor disagree disagree
know
a) sufficiently clear
b) sufficiently
comprehensive
c) effectively
implementable
d) consistent with other
EU definitions
Question 4b. To what extent do you agree with the following statements as
regards specific (present or missing) elements of the nanomaterial definition
in the Cosmetic Products Regulation?
(Single answer per row)
Neither
Don’
Strongly agree Strongly
Agree Disagree t
agree nor disagree
know
disagree
The condition of ‘insoluble or
biopersistent’ (i.e. sufficiently
stable and persistent in biological
media to allow for potential
interaction with biological
systems):
a) is required as part of the
nanomaterials definition in
cosmetics
b) should be removed as a
condition for restricting a class of
nanomaterials
c) should be kept as a condition,
but properly defined
The condition of ‘intentionality’:
a) is required as part of the
nanomaterials definition in
cosmetics
b) should be removed as a
condition for restricting a class of
nanomaterials
21
c) should be replaced by ‘natural,
incidental or manufactured
material’
For implementation reasons, a %
threshold for the particle number
in the size distribution should be
set
a) a % threshold for the particle
number in the size distribution
should be consistent with the
horizontal definition (i.e. 50%) (as
in regulations such as REACH,
BPR and Medical Devices)
b) if there are any safety
concerns, and irrespective of the
horizontal definition of
nanomaterial, the number size
distribution threshold of 50 %
may be lowered in order to follow
the most appropriate safety
assessment
The scope of application of the
future definition should take
account of additional or specific
requirements and sector
particularities
a) The scope of application of the
current definition may be
extended, but it should not
contradict the future cross-
sectoral definition
b) The scope of application of the
current definition may be
restricted, but it should not
contradict the future cross-
sectoral definition
Guidance documents are needed
to ensure a proper application of
the nanomaterial definition in
cosmetics
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Question 4c. What impact would you expect an updated definition of nanomaterial in cosmetics to have in the EU?
Very No or Very
Positive Negative Don't
positive limited negative
impact impact know
impact impact impact
A new definition with revised conditions concerning ‘insolubility/biopersistence’
would most likely have...regarding the following:
a) Compliance and administration costs for the cosmetics industry (including testing
costs, reformulation costs, etc.)
b) Research and development / innovation for the cosmetics industry
c) Competitiveness of the EU cosmetics sector and wider industry in the global
market
d) Laboratory capacity and associated costs
e) Employment levels
f) Public authorities’ resources, including administrative burden and enforcement
costs
A new definition with revised conditions concerning ‘intentionality’ would most
likely have…regarding the following:
a) Compliance and administration costs for the cosmetics industry (including testing
costs, reformulation costs, etc.)
b) Research and development / innovation for the cosmetics industry
c) Competitiveness of the EU cosmetics sector and wider industry in the global
market
d) Laboratory capacity and associated costs
e) Employment levels
f) Public authorities’ resources, including administrative burden and enforcement
costs
23
A new definition with revised conditions concerning ‘% threshold for the particle
number in the size distribution’ would most likely have…regarding the following:
a) Compliance and administration costs for the cosmetics industry (including testing
costs, reformulation costs, etc.)
b) Research and development / innovation for the cosmetics industry
c) Competitiveness of the EU cosmetics sector and wider industry in the global
market
d) Laboratory capacity and associated costs
e) Employment levels
f) Public authorities’ resources, including administrative burden and enforcement
costs
24
5 Changes to the information provided on labels of cosmetic products
The Cosmetic Products Regulation lays down rules for information to be labelled on the container and/or
the packaging of a cosmetic product. There are currently no rules laid down for digital labelling, i.e. online
labelling with the information accessible through a QR code, a website, etc.
Given that labels are the primary means to communicate essential product information to users, clear
communication is vital for legislation to be effective in protecting human health. The Fitness Check of the
most relevant chemicals legislation (excluding REACH) found that consumer understanding of labels and
consequently consumer protection can be improved by avoiding overloading labels with information and
making them more easily readable. One solution could be to move information from a physical label (on-
pack) to a digital label. If the information is provided in a digital label, the manufacturers would need to find
a way to provide this information to consumers without mobile internet access.
There is ongoing discussion in the Commission on the scope for digital labelling under the CLP, Detergents
and Fertilising products Regulations. This is detailed in an ongoing study and an open public consultation
on the simplification and digitalisation of labelling requirements of chemicals.
25
Question 5. Which way of providing information is best in your view for the following categories of information?
(Single answer per row)
Digital labelling only Digital labelling only (e. Both on-pack and
Depending on the type of
(e.g. through a QR g. through a QR code) digital labelling, (for
information - certain information on
On- code) with an with no alternative way example, for the row Don’
pack and certain by digital labelling,
pack alternative way of of providing ‘list of ingredients’, all t
(for example, for the row ‘list of
only providing information information to those ingredients both on know
ingredients’ certain ingredients on
to those with no with no mobile internet pack and by digital
pack and certain by digital labelling)
internet access access labelling)
The name and
the address of
the responsible
person
(manufacturer,
importer,
distributer, other)
The country of
origin if products
are imported
from outside the
EU
The nominal
content (weight
or volume) of the
product
The date of
minimum
durability of the
products or the
date of durability
26
after opening of
the product
Safety warnings
(e.g. ‘not to be
used on
eyelashes’, ’only
for professional
use’.)
Batch number or
the reference for
identifying a
cosmetic product
The function of
the product (e.g.
anti-wrinkle
cream,
moisturiser,
shampoo etc.)
The full list of all
ingredients
27
Question 5a. In your view, what would be the impact of digital labelling of
information in general?
Very No or Very
Positive Negative Don't
positive limited negative
impact impact know
impact impact impact
Economic impact (one-off costs)
Economic impact (recurrent
costs)
Economic impact (other such as
impact on reputation, costs of
import/export, etc.)
Environmental impact (e.g. due
to smaller packaging, higher
energy consumption due to
digitalisation)
Social impact (e.g. access to
information)
Impact for market surveillance
authorities (in-market controls)
Other comments: maximum 250 words
2000 character(s) maximum
6 Scientific and technical work on cosmetics performed by the Scientific Committee
on Consumer Safety (SCCS) and the potential to improve the efficiency,
effectiveness and coherence of safety assessments across legislation
Currently, different agencies and scientific committees provide scientific advice to the Commission on
chemicals, including cosmetics. The efficiency of maintaining several committees assessing the same
chemical is questionable, for example in terms of secretariat support, data management and the time and
resources needed for coordination with other committees.
To improve the effectiveness, efficiency and coherence of safety assessments across EU legislation and to
make best use of expertise and resources in the EU agencies, in line with the ‘one substance, one
assessment’ approach, the Chemicals Strategy proposed reassigning the technical and scientific work on
chemicals carried out under the relevant pieces of legislation to EU agencies. This includes the work of the
SCCS.
Question 6. To what extent do you agree with the following statements?
28
Moving the SCCS to a European agency will improve:
Neither Don’
Strongly Strongly
Agree agree nor Disagree t
agree disagree
disagree know
a) the efficiency of safety
assessments across sectors
b) synergies amongst
different sectors
c) the consistency of safety
assessments across sectors
d) the transparency of
procedures
Through the work carried out to implement the Registration, Evaluation, Authorisation and Restriction of
Chemicals (REACH) Regulation, the European Chemicals Agency (ECHA) is already responsible for the
environmental risk assessment of ingredients used in cosmetics products. Therefore, to maximise
synergies and ensure consistency in the risk assessment of chemical substances, the Commission
proposed reassigning the scientific/technical work to ECHA.
The Commission intends to maximise the efficiency and consistency of chemicals’ assessment across
sectors, while maintaining the dedicated expertise and respecting the particularities of the cosmetics sector.
Various options are being considered, depending on the level of possible integration of the work of SCCS
into ECHA structures. ECHA implements the EU’s chemicals legislation and has a wide knowledge base on
multiple chemicals and extensive experience with the risk assessment of chemical substances, including in
occupational settings and in non-food consumer products. The following broad options have been identified:
Option 1: business as usual (baseline scenario) - SCCS remains with the Commission;
Option 2: a stand-alone SCCS within ECHA. The SCCS is strengthened in order to maximise
synergies with existing scientific capacities of ECHA. Existing high-level expertise and methodologies
of the SCCS are preserved (e.g. non-animal methods);
Option 3: SCCS work is integrated into the Risk Assessment Committee (RAC) of ECHA, after
adaptation of the RAC framework/structure and membership to ensure sufficient capacity to deal with
a higher number of assessments and ensuring sufficient expertise and continuity of existing
methodologies developed by the SCCS;
Option 4: SCCS is absorbed by the Risk Assessment Committee (RAC) of ECHA without adapting
the RAC. In this case, the RAC framework/structure, membership and methodology will apply.
Question 6a. Please consider the impact of the four options outlined above
for re-assigning the work of the SCCS, on a scale from 1 (strongly negative i.
e. detrimental) to 5 (strongly positive, i.e. beneficial) as regards:
(Single answer per row)
29
1 5 Don’
2 3 4
(strongly (strongly t
negative) positive) know
a) Efficiency of safety assessments across
legislation (e.g. timely delivery of opinions
/assessments, cost and resource efficiency):
Option 1 (baseline)
Option 2 (stand-alone committee at ECHA)
Option 3 (integration into RAC with adaptation)
Option 4 (absorption into RAC without
adaptation)
b) Synergies amongst different sectors:
Option 1 (baseline)
Option 2 (stand-alone committee at ECHA)
Option 3 (integration into RAC with adaptation)
Option 4 (absorption by RAC without adaptation)
c) Consistency of assessments across
sectors:
Option 1 (baseline)
Option 2 (stand-alone committee at ECHA)
Option 3 (integration into RAC with adaptation)
Option 4 (absorption by RAC without adaptation)
d) Preserving expertise and methodology on
cosmetic ingredients (e.g. alternative
methods to animal testing, notes of
guidance, etc.):
Option 1 (baseline)
Option 2 (stand-alone committee at ECHA)
Option 3 (integration into RAC with adaptation)
Option 4 (absorption by RAC without adaptation)
e) Transparency in procedures (e.g.
information requirements, compliance
checks, open hearings, consultations, etc.):
Option 1 (baseline)
Option 2 (stand-alone committee at ECHA)
Option 3 (integration into RAC with adaptation)
Option 4 (absorption by RAC without adaptation)
30
f) Costs for businesses (industry and SMEs):
Option 1 (baseline)
Option 2 (stand-alone committee at ECHA)
Option 3 (integration into RAC with adaptation)
Option 4 (absorption by RAC without adaptation)
Question 6b. Please elaborate on other impacts you consider important:
maximum 500 words
4000 character(s) maximum
Final (additional) feedback
Question 7. If you would like to share anything else in addition to the
previous questions related to the targeted revision of the Cosmetic Products
Regulation, please provide details here (optional):
Kosmeetikatoodete määruse reguleerimisalasse ei kuulu küll keskkonnariskid, kuid leiame, et
kosmeetikatoodete puhul on oluline hinnata toodete kogu olelusringi, hinnates sealjuures toote ja selles
sisalduvate ainete mõju keskkonnale kõigis aspektides: toote disainil, toote kasutamisel ja toote
jäätmeetapis. Hinnangu andmisel on lisaks terviseohtlikkuse küsimustele oluline ka see, kuidas
kosmeetikatootes kasutatud ained satuvad keskkonna erinevatesse elementidesse või käituvad nendes,
eemaldades neid nahalt (nt PFOA päikesekaitsevahendites) või pakenditest pesemise teel (toote
kasutamisel) või käideldes neid jäätmetena, põhjustades seeläbi võimalikke kaudseid, kuid pikaajalisi
mõjusid. Kosmeetikatoodete üldiste nõuete ülevaatamise käigus tuleks mõelda ka pakendijäätmete tekke
vältimisele ja vähendamisele ning suunama tootjaid välja töötama pakendeid, mida oleks võimalik rohkem
korduskasutada.
Question 8. If you would like to share a document related to the targeted
revision of the Cosmetic Products Regulation, please upload it below
(optional):
Only files of the type pdf,txt,doc,docx,odt,rtf are allowed
Contact
[email protected]
31
32
SELETUSKIRI Avalik konsultatsioon kosmeetikatoodete määruse sihipärase läbivaatamise kohta Ülevaade ja eesmärk Euroopa Komisjon algatas 29. märtsil 2022. a avaliku konsultatsiooni kosmeetikatoodete määruse läbivaatamisek s, keskendudes eelkõige mitmesugustele tegevustele ja võimalikele meetmetele, et parandada kosmeetikatoodete suhtes kehtivate eeskirjade tõhusust ja tulemuslikkust. Konsultatsiooni eesmärgiks on koguda teavet, arvamusi ja kogemusi erinevatelt huvitatud sidusrühmadelt ning üksikisikutelt selle kohta, kuidas oleks võimalik kosmeetikatoodete määrust parandada, et tagada inimeste tervis ja siseturu toimimine. Konsultatsioonile vastamise tähtaeg on 21. juuni 2022. a. Kosmeetikatoodete määrus on peamine õigusraamistik ELi turule lastavate kasutusvalmis kosmeetikatoodete jaoks. Selles on sätestatud eeskirjad, mida kohaldatakse kõigi kosmeetikatoodete suhtes, et tagada hästi toimiv siseturg ja inimeste tervise kõrgetasemeline kaitse. Selle s ihipärase läbivaatamise üldine eesmärk on tagada, et kosmeetikatoodete määrus kajastaks kestlikkust toetavas kemikaalistrateegias (edaspidi „ ELi kemikaali strateegia“ ) kirjeldatud Euroopa Komisjoni eesmärki paremini kaitsta üldsust ja keskkonda ohtlike kemikaalide eest ning soodustada ELi rohelise kokkuleppe raames innovatsiooni ohutute ja kestlike alternatiivide väljatöötamisel . EL i kemikaalis trateegias tunnistatakse vajadust kosmeetikatoodete määrus sihipäraselt läbi vaadata, et lahendada mitmed tuvastatud probleemid ning saavutada seeläbi strateegia eesmärgid. Nende probleemide lahendamiseks kaalu takse mitmeid võimalikke meetmeid: kõige kahjulikumate kemikaalide automaatne keelustamine („riskijuhtimise üldine lähenemisviis“), lubades nende kasutamist ainult juhul, kui on tõestatud selle hädavajalikkus ühiskonna jaoks; uus meede, milles võetakse arvesse kombineeritud mõju, mis tuleneb samaaegsest või üksteise järel toimuvast kokkupuutest eri allikatest pärit kemikaalidega; nanomaterjali määratluse läbivaatamine; kosmeetikatoodete märgistusel oleva teabe täpsustamine ning kosmeetikatoodete teadusliku hindamise lihtsustamine, andes tarbijaohutuse komitee töö üle Euroopa Kemikaaliametile (ECHA). Käesoleva avaliku konsultatsiooniga samal ajal toimub mitu eraldi sihipärast konsulteerimist sidusrühmadega, et saada kosmeetikatoodete määruse võimalike muudatuste kohta üksikasjalikumat tehnilist teavet. Koostajad Seletuskirja koostasid sotsiaalministeeriumi EL ja väliskoostöö osakonna nõunik Elen Ohov (
[email protected] ) ja rahvatervise osakonna peaspetsialist Gerlin Kallas (
[email protected] ) . Seletuskirja on kooskõlastanud valdkonna eest vastutav terviseala asekantsler Heidi Alasepp. Avalikule konsultatsioonile vastamise üldpõhimõtted Avalikule konsultatsioonile vastamisel tugineme 10.12.2020 VV istungil ja 14.12.2020 Riigikogu EL asjade komisjonis heaks kiidetud Eesti seisukohtadele Euroopa Komisjoni algatuse „Kestlikkust toetav kemikaalistrateegia. Mürgivaba keskkonna loomise suunas (COM(2020) 667)“ kohta. Eesti seisukohad on kooskõlas rahvastiku tervise arengukavaga 2020-2030 (VV heaks kiidetud 29.04.2021) ja selle tervist toetava keskkonna programmiga ning Eesti vähitõrje plaaniga (kinnitatud tervise- ja tööministri 30.04.2021 käskkirjaga nr 46). Seisukohad on kooskõlas 06.04.2022 KOKis heakskiidetud Eesti seisukohtadega REACH-määruse läbivaatamise avalik u konsultatsiooni kohta. Avaliku konsultatsiooni vastused on lisatud seletuskirjale. Esialgne mõjude analüüs Kosmeetikatoodete määruse sihipärase läbivaatamise eesmärk on aidata kaasa tarbijate ja haavatavate rühmade kaitsele, vähendades kokkupuudet kõige kahjulikumate kemikaalidega. Kemikaalide ohtude ja riskide hindamist ning juhtimist ELis reguleeriva raamistiku üldise ajakohastamise kontekstis võib kosmeetikatoodete määruse läbivaatamine avaldada positiivset mõju nii ettevõtjate kui ka riiklike ametiasutuste jaoks seoses praeguste ja tulevaste kemikaalide tootmise ja kasutamise prognoosimisega. Näiteks võib kosmeetikatoodetes sisalduvaid aineid käsitlevate teaduslike nõuannete ühtlustamine viia ressursside järjekindlama ja tõhusama kasutamiseni ning tagada, et hindamismeetodid on erinevates kemikaalialastes õigusaktides sidusamad ja ühtlustatud. Kosmeetikatoodete määruse läbivaatamise üheks eesmärgiks on parandada õigusselgust ja toetada seeläbi ELi tööstuse konkurentsivõimet ülemaailmsel tasandil. Eelkõige on ajakohastatud regulatiivse raamistiku eesmärk aidata tööstusel tulevikus tõhusalt ja õigeaegselt täita keskkonnasäästlike kemikaalide tootmise ja kasutamisega seotud nõudeid. Lisaks on muude ELi kemikaale käsitlevate õigusaktidega kooskõlas olevate kosmeetikatoodete eeskirjade eesmärk hõlbustada ettevõtjate tegevust selles sektoris, parandades vastavustoimingute kulutõhusust. Eeldata valt aitavad mõned kosmeetikatoodete määruse muudatused, näiteks nanomaterjalide osas tehtavad muudatused ning kahjulike ainete riskihindamise ja -juhtimise täiustamine, vähenda da tõenäoliselt tööstuse kulusid. Samas võivad muud muudatused, mis tuleneks rangemate eeskirjade kehtestamisest kõige kahjulikumatele kemikaalidele (nt endokriinfunktsiooni kahjustajad), eranditoimikute koostamisest ja ohutusandmete kogumisest ning vajadusest muuta kosmeetikatoodete koostist, kaasa tuua tööstuse, sealhulgas väikese- ja keskmise suurusega ettevõtete (VKEd) , kulude suurenemise kogu tarneahelas. Digitaalne märgistus või ks eelkõige suurendada tööstuse kulutõhusust, nt halduskulude vähenemise ja sageli muudetavate etikettide teabe kiire kohandamise tõttu, samuti hõlbustades märgistamisnõuete järgimist ja lihtsustades toodete vastavuse kontrollimise protsesse (turujärelevalveasutuste jaoks asjakohane nt kohandatud teabe, kiirete otsingute ja keelte kaudu). Samuti võib tulevikus täheldada positiivseid majanduslikke mõjusid, mis tulenevad kõige kahjulikumate kemikaalide negatiivsete tervisemõjude majandusliku koormuse vähenemisest. Eesti seisukohad ja nende põhjendused Toetame kosmeetika toodete määruse s selliste kõige kahjulikemate kemikaalide loetelu täiendamist, millele kohaldatakse riskijuhtimist käsitleva t üldis t lähenemisviisi , kuna see aitab paremini kaitsta inimeste tervist ning kiiremini reguleerida riske. Toetame olulise kasutusala mõiste väljatöötamist ja kasutusele võtmist piirangute seadmisel erandite lubamiseks. Selgitus : ELi kemikaalis trateegias esitati ettepanek laiendada riskijuhtimise üldist lähenemisviisi, mis tähendab, et kõige kahjulikumad kemikaalid keelatakse vaikimisi, lubades samal ajal väheseid erandeid selgelt määratletud tingimustel. K osmeetikatoodete määruse kohast üldist lähenemisviisi laiendatakse EL-i kemikaalistrateegia ettepaneku kohaselt nii, et see hõlmaks ka inimeste endokriinfunktsiooni kahjustavaid kemikaale, immuunsust, närvisüsteemi või hingamisteid mõjutavaid kemikaale ja konkreetsele elundile mürgiseid kemikaale, lähtudes nendega seotud ohtudest ja üldistest kokkupuutega seotud kaalutlustest. See erineb riskijuhtimise sihitud lähenemisviisist, mille korral on enne kasutuspiirangu kehtestamist vaja iga kasutusala puhul tõendeid vastuvõetamatu riski kohta. Kehtivas k osmeetikatoodete määruses ei ole selliseid sõnaselgeid sätteid endokriinfunktsiooni kahjustavate , ega immuunsust, närvisüsteemi või hingamisteid mõjutavate ning konkreetsele elundile mürgiste kemikaalide kasutamise keelamise või piiramise kohta, nagu on kantserogeensete, mutageensete või reproduktiivtoksiliste (KMR) ainete puhul. Praegu saab neid aineid kosmeetikatoodete määruse kohaselt piirata ainult siis, kui need võivad ohustada rahvatervist. ELi kemikaalis trateegias on kavandatud mitu kohustust ka keemilise saaste ja kokkupuute vähendamiseks, et kaitsta paremini inimesi ja keskkonda ning soodustada rohepöördeks ohutute ja keskkonnasäästlike kemikaalide ja toodete innovatsiooni. Riskijuhtimiste üldise lähenemisviisi laiendamine tagab tarbijate, haavatavate elanikkonnarühmade ja looduskeskkonna järjepidevama kaitse, võimaldades samas kasutada kõige kahjulikumaid kemikaale seal, kus see on ühiskonna jaoks tõendatult vajalik. Tagamaks, et kõige kahjulikumate kemikaalide kasutamine oleks lubatud ainult juhul, kui see on tervise, ohutuse või ühiskonna toimimise jaoks hädavajalik ning kui puuduvad alternatiivid, mis oleksid keskkonna ja tervise seisukohast vastuvõetavad , tuleb selge lt määrata oluliste kasutusalade kriteeriumid, mis võimaldaks kahjulikumate ainete kasutamise ainult erandkonnas ja väga rangetel tingimustel. Olulise kasutusala kontseptsiooni väljatöötamise arutelu on aga alles algusjärgus ja ilma kokkulepitud põhimõteteta on keeruline hinnata, millisel juhul on kosmeetikatoodetes ainete kasutamise lubamise juures asjakohane hinnata olulist kasutusala. Nõustume, et segu hindamisteguri kasutuselevõtt on sobiv lähenemisviis tahtmatust kemikaalide segudega kokkupuutest tulenevate riskide vähendamiseks. Samas l eiame, et kosmeetikatoodete ohutuse hindamisel oleks sobivaim segu hindamistegurit kasutada ainult kantserogeensete, mutageensete või reproduktiivtoksiliste ainete, endokriinfunktsiooni kahjustavate, immuunsust, närvisüsteemi või hingamisteid mõjutavate ning konkreetsele elundile mürgiste kemikaalide suhtes. Selgitus: Mitmesugused uuringud on näidanud , et keemilised ained võivad kombineeritult avaldada kahjulikku mõju inimeste tervisele, isegi kui üksikud ained esinevad kontsentratsioonis, mida peetakse ohutuks. Enamikes kemikaale käsitlevates õigusaktides käsitletakse spetsiaalselt koostatud ja kaubanduslikke segusid ja nõutakse selliste segude riskihindamist. Paljudes õigusaktides puudub siiski nõue võtta arvesse tarbijate kokkupuudet mitmest allikast pärit keemiliste ainetega (või nn tahtmatute segudega). ELi kemikaalis trateegias on märgitud, et selleks, et asjakohaselt käsitleda kemikaalide kombineeritud mõju tahtmatutes segudes, tuleb kõigis kemikaalidega seotud poliitikavaldkondades järjekindlalt kehtestada õiguslikud nõuded selleks, et võtta tõhusalt ja süstemaatiliselt arvesse mitme kemikaaliga samaaegse kokkupuute riski. Vastavalt komisjoni rakendusotsusele 2013/674/EL („Suunised kosmeetikatoote ohutushinnangu kohta“) kaaluvad kosmeetikatoodete ohutuse hindajad kosmeetikatoodetes kasutatavate koostisainete (tahtlike segude) võimalikku kombineeritud mõju, võttes arvesse kindlakstehtud tavakasutust ja mõistlikult eeldatavat kasutust. Puudub k ohustus kaaluda kosmeetikatoodetes sisalduvate kemikaalide kombineeritud mõju muude ainetega, millega tarbija kokku puutub. Nendeks võivad olla muudes kosmeetikatoodetes sisalduvad ained või ained, mis on pärit muudest allikatest, nagu värvid või toidus ja vees leiduvad saasteained. Komisjoni segusid käsitlevas eduaruandes on toodud päriselu näiteid sellise kokkupuute ja toime kohta. Kuna ei ole realistlik ega majanduslikult otstarbekas konkreetselt hinnata ja reguleerida peaaegu lõpmatut hulka võimalikke kemikaalikombinatsioone, oleks mitme kemikaaliga samaaegse kokkupuute riski hindamiseks mõistlik võtta kosmeetikatoodete ohutuse hindamisel kasutusele segu hindamistegur (MAF, mixtures assessment factor) , mis on pragmaatiline meetod tundmatute riskide haldamiseks, kuna ohutuse hindaja ei ole teadlik kõigist ainetest, mis võivad mõjutada ka inimeste tervist. Praktikas vähendatakse MAFi kasutamisel üksikute kemikaalide puhul piisavalt ohutuks peetavaid kokkupuutetasemeid teatava teguri võrra, et kaitsta mitme kemikaaliga kombineeritud kokkupuute riski eest. Leiame, et kosmeetikatoodete kombineeritud mõju muude ainetega oleks mõistlik hinnata üksnes kõige kahjulikemate kemikaalide ( KMR id, endokriinfunktsiooni kahjustavad ained , immuunsust, närvisüsteemi või hingamisteid mõjutavad ning konkreetsele elundile mürgised kemikaalid ) suhtes. See tähendab, et hinnatakse tahtmatut samaaegset kokkupuudet ainult nende kosmeetikatoodetes kasutatavate kõige kahjulikemate ainete ja mis tahes muude ainetega, millega tarbija võib kokku puutuda. Samuti leiame, et erinevaid hindamisteguri väärtusi tuleks kohaldada tarbijatele ja kutsetöötajatele. Toetame n anomaterjali määratlus e ajakohastamis t ning s ektoriüles t ühtlustamis t , et hõlbustada järjepidev at ja tõhus at õigusnormide kohaldami st. Leiame, et kosmeetikatoodete määruses praegu sisalduv nanomaterjalide määratlus ei ole piisavalt selge , põhjalik ega kooskõlas teiste s ELi õigusaktide s esitatud määratlusega ning tuleks viia kooskõlla komisjoni nanomaterjalide määratluse soovitusega. Selgitus: Nanomaterjale iseloomustab nende väga väike suurus, mida mõõdetakse nanomeetrites (üks miljondik millimeetrit) ning mida pole võimalik palja silmaga näha. Nanomaterjale leidub looduses, näiteks rannaliivas, kuid neid ka toodetakse ja lisatakse tarbekaupadele, kuna neil on või nendega võivad kaasneda uudsed omadused (näiteks suurem tugevus, keemiline reaktsioonivõime ja juhtivus jne) võrreldes sama materjaliga, millel ei ole nanoskaala omadusi. Kosmeetikatoodete määruses on nanomaterjal määratletud kui „lahustumatu või bioloogiliselt püsiv kindlal eesmärgil valmistatud materjal, mille ühe või enama välismõõte või sisemise struktuuri suurus on vahemikus 1-100 nm“. Komisjon i 2011. aastal vastu võetud soovituse kohaselt, tuleks nanomaterjalide määratlu st kasutada horisontaalse mõistena, mille kohaselt on nanomaterjal „looduslik, juhuslikult tekkinud või tööstuslikult toodetud materjal, mis on sidumata olekus või esineb kämbu või pahma kujul ning mille lõimisest vähemalt 50 % moodustab fraktsioon osakestest, mille üks või mitu välismõõdet on vahemikus 1-100 nm“. Määratlus on spetsiaalselt kohandatud selleks, et hõlbustada järjepidevat ja tõhusat õigusnormide kohaldamist . Sellisena on seda ka mitmes ELi määruses kasutatud, sealhulgas kemikaalide registreerimist, hindamist, autoriseerimist ja piiramist käsitlevas määruses (REACH) , biotsiidide määruses ja meditsiiniseadmete määruses . Kuna k osmeetikatoodete määruses ja komisjoni 2011. aasta soovituses esitatud nanomaterjali määratluses on erinevusi , siis s elle tulemusena on nanomaterjaliks liigitamine sektoriti erinev. Näiteks käsitatakse mõnda materjali REACH-määruses nanomaterjalina, kuid kosmeetikatoodete määruses mitte või vastupidi. See võib tekitada ühtsel turul küsimusi ja põhjustada ebajärjekindlat lähenemist pädevate asutuste ja ettevõtjate seas. P raegu vaatab komisjon soovitust läbi, et viia sisse väikesed muudatused. Esimese soovituse vastuvõtmisega 2011. aastal võttis komisjon endale kohustuse soovituse abil tagada, et nanomaterjalide määratlus ELi eri määrustes oleks ühtne. Leiame, et kosmeetikatoodete määruses tuleks nanomaterjalide määratlust ajakohastada ning uue määratluse kohaldamisala ei tohiks olla vastuolus tulevase sektoriülese määratlusega. Toetame k osmeetikatoodete märgistus nõuete lihtsustamist ja märgistuse digitaliseerimist tarbijatele arusaadavamaks tegemise eesmärgil, et kaitsta tõhusamalt inimeste tervist, kuid leiame, et tarbijad ei tohiks jääda ebavõrdsesse seisu erinevate tehniliste võimaluste tõttu. Selgitus: Kosmeetikatoodete määruses on sätestatud eeskirjad kosmeetikatoote mahutile ja/või pakendile märgitava teabe kohta. Praegu puuduvad eeskirjad digitaalse ehk veebipõhise märgistuse kohta, kus teave on kättesaadav QR-koodi, veebisaidi jne kaudu. Kuna märgistus on peamine vahend olulise tooteteabe kasutajale edastamiseks, on selge teavitamine väga oluline, et inimeste tervist saaks tõhusalt kaitsta . Kõige olulisemate kemikaale käsitlevate õigusaktide (v.a REACH) toimivuskontrolli tulemusena leiti, et tarbijate arusaamist märgistest ja seega ka tarbijakaitset saab parandada, kui märgised ei ole teabega üle kuhjatud ja on kergemini loetavad. Üheks lahenduseks võiks olla teabe viimine füüsiliselt märgiselt (pakendil) digimärgisele. Kui teave esitatakse digimärgisel, peavad tootjad leidma viisi selle teabe edastamiseks tarbijatele, kellel puudub mobiilne internetiühendus. Komisjonis on praegu käimas arutelu digitaalse märgistuse kohaldamisala üle CLP-määruses , detergentide määruses ja väetisetoodete määruses . Teemat käsitletakse üksikasjalikult käimasolevas uuringus ja avalikul konsultatsioonil kemikaalide märgistusnõuete lihtsustamise ja märgistuse digitaliseerimise kohta . Leiame, et toote info digitaalse kuvamise võimalused sõltuvad spetsiaalse tootegrupi omadustest, samas ei tohiks tarbijad jääda ebavõrdsesse seisu erinevate tehniliste võimaluste tõttu. Koostisainete kuvamise puhul peame vajalikuks koostisainete täieliku loetelu märkimist ka pakendil . Peame oluliseks, et k emikaalidega seotud õigusaktides kavandatavad digitaalsed märgistuslahendused töötatakse välja koostoimes digitaalse tootepassi tehnilise lahendusega. Nõustume ettepanekuga anda teaduslik ja tehniline töö kosmeetikatoodete osas , sh tarbijaohutuse komitee (SCCS) töö, üle Euroopa Kemikaaliametile ( ECHA ) , mis annab võimalus e parandada ohutushinnangute tõhusust, tulemuslikkust ja sidusust kõigis õigusaktides . Selgitus: Praegu annavad komisjonile kemikaalide, sh kosmeetikatoodete kohta teaduslikku nõu erinevad ametid ja teaduskomiteed. Küsitav on, kas sama kemikaali hindamine mitmes eri komitees on tõhus lähenemine, näiteks sekretariaaditeenuste, andmehalduse ning teiste komiteedega kooskõlastamiseks vajaliku aja ja ressursside tõttu. Selleks , et parandada ohutushinnangute tõhusust, tulemuslikkust ja sidusust kõigis õigusaktides ning kasutada parimal viisil ära ELi ametite eksperditeadmisi ja ressursse, tehti ELi kemikaali strateegias lähenemisviisi „üks aine, üks hindamine“ kohaselt ettepanek anda asjaomaste õigusaktide alusel kemikaalidega seotud tehniline ja teaduslik töö üle ELi ametitele. See hõlmab ka tarbijaohutuse komitee (SCCS ) tööd . ECHA vastutab REACH -määruse rakendamiseks tehtava töö tõttu juba praegu kosmeetikatoodetes kasutatavate koostisainete keskkonnaohu hindamise eest. Selleks , et suurendada sünergiat ja tagada keemiliste ainete riskihindamise järjepidevus, tegi komisjon ettepaneku anda teadus- ja tehnikaalane töö üle ECHA-le . E esmärk on maksimeerida kemikaalide hindamise tõhusust ja järjepidevust kõigis sektorites, säilitades samal ajal eksperditeadmised ja võttes arvesse kosmeetikatoodete sektori eripärasid. ECHA rakendab kemikaale käsitlevaid ELi õigusakte ning tal on laialdased teadmised paljudest kemikaalidest ja ulatuslikud kogemused keemiliste ainete riskihindamisel, sh töökeskkonnas ja toiduks mittekasutatavates tarbekaupades. Kaalumisel on mitu varianti sõltuvalt sellest, kui suure osa tarbijaohutuse komitee tööst saab ECHA struktuuri integreerida. Esimese v arian di kohaselt jätkub tavapärane tegevus (lähtestsenaarium) ning SCCS jääb komisjoni alluvusse. Teise variandi korral oleks SCCS eraldi komitee ECHAs. SCCSi tugevdatakse, et suurendada koostoimet ECHA olemasoleva teadussuutlikkusega. Säilivad SCCSi olemasolevad kõrgetasemelised eksperditeadmised ja metoodika (nt loomkatsevabad meetodid). Kolmanda variandina integreeritaks SCCSi töö ECHA riskihindamise komitee (RAC) töösse pärast seda, kui RACi raamistikku/struktuuri ja liikmeskonda on kohandatud, et tagada piisavad eksperditeadmised ja võimekus suurema arvu hindamiste läbiviimiseks ning SCCSi poolt välja töötatud olemasolevate meetodite järjepidevus. Nelja n da variandi korral integreeritaks SCCS RAC i koosseisu ilma RACi kohandamata. Sel juhul kohaldatakse RACi raamistikku/struktuuri, liikmeskonda ja metoodikat. Eelistatuim nendest valikutest oleks teine lahendusvariant, mille puhul oleks SCCS eraldi komitee ECHAs. Säiliksid olemasolevad kõrgetasemelised eksperditeadmised ja metoodika ning komitee tööd tugevdatakse, et suurendada koostoimet ECHA olemasoleva teadussuutlikkusega. Peame oluliseks erinevate sektorite vahelist sünergiat, koostoime s töötamist ning ekspertteadmiste kaasamist . Arvamuse saamine ja kooskõlastamine Konsultat s ioonile vastamisel on arvestatud Keskkonnaministeeriumi, Majandus- ja Kommunikatsiooniministeeriumi ning Terviseameti sisendiga. Arvamust on küsitud ka Eesti Keemiatööstuse Liidult.