Source: EURLEX
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# 52013SC0067

**COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT ON THE ANIMAL TESTING PROVISIONS IN REGULATIO (EC) 1223/2009 ON COSMETICS Accompanying the document Communication from the Commission to the European Parliament and the Council on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics \_ /\* SWD/2013/067 final \*/**

  

COMMISSION STAFF WORKING DOCUMENT

EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT
ON THE ANIMAL TESTING PROVISIONS IN REGULATIO (EC) 1223/2009 ON COSMETICS

Accompanying the document

Communication from the Commission
to the European Parliament and the Council

on the animal testing and
marketing ban and on the state of play in relation to alternative methods in
the field of cosmetics

Introduction

The Cosmetics Directive[1] foresees a phasing-out of
animal testing for cosmetic products. A ban of animal testing of finished
cosmetic products has been in force since September 2004 and a testing ban on
ingredients or combinations of ingredients in order to meet the requirements of
the Directive since March 2009. As from March 2009, it is also prohibited in
the EU to market cosmetic products and their ingredients which have been tested
on animals in order to meet the requirements of the Directive, irrespective of
the origin of these products. This marketing ban applies to all but the most
complex human health effects to be tested to demonstrate the safety of cosmetic
products (repeated-dose toxicity including skin sensitisation and
carcinogenicity, reproductive toxicity and toxicokinetics), for which the
legislator extended the deadline to March 2013.

The assessment of the 2013 marketing ban deadline
is foreseen in the Cosmetics Directive itself. Article 4a (2.3) of the
Cosmetics Directive obliges the Commission to study the progress and compliance
with the implementation deadlines in relation to animal testing and to report
to the European Parliament and the Council. In particular, the Directive
provides that if alternatives to animal testing in relation to the endpoints
covered by the 2013 marketing ban are not developed and validated by the 2013
implementation date, the Commission shall inform the European Parliament and
the Council and put forward a legislative proposal. These provisions were not
changed by the recast of the Cosmetics Directive by Regulation 1223/2009/EC[2]. The Cosmetics Regulation
repealing the Cosmetics Directive as of 11 July 2013, any proposal would amend
the Cosmetics Regulation only.

The Commission has monitored the progress
in the development of alternative methods to animal testing on a yearly basis
and presented its final report to the European Parliament and the Council[3] on 13 September 2011. It
concludes that alternatives to animal testing in relation to endpoints in
question will not yet be available by 2013. It is against this background that
the potential impacts of the possible policy options in relation to the 2013
deadline are assessed.

1.           Problem
definition

Efforts to completely end animal use for
cosmetic purposes go back a long time. First provisions in relation to the
marketing ban of cosmetic ingredients or combinations of ingredients tested on
animals in order to meet the requirements of the Directive were introduced to
the Cosmetics Directive in 1993, with a foreseen application by 1998, and then
postponed three times because alternative methods were not yet available. The
current provisions were introduced in 2003.

Virtually every European citizen uses a
multitude of cosmetic products every day, from soap, shampoo, conditioner,
deodorant, toothpaste, shaving cream, aftershave, cleanser, perfume, make-up to
a whole range of other products. The objective of the Cosmetics legislation is
on the one hand to ensure that consumer health is not put at risk by their use and
on the other hand to ensure that these products can circulate freely in the
Union. To this end the responsible person must carry out a safety assessment,
which includes a study of the intrinsic properties of all ingredients contained
in the product. A number of key human health endpoints need to be addressed in
this assessment, such as whether the ingredient can cause allergies or damages
health as a result of its repeated use.

Some of the questions that must be
addressed in the safety assessment can currently only be answered by relying on
toxicological data obtained from animal testing. Alternative methods to replace
these tests will according to the Commission findings not be available by 2013.
The problem is therefore in a nutshell that the marketing ban would apply as of
11 March 2013 in the absence of full alternative methods. Under the Cosmetics legislation
only cosmetic products that are safe for human use can be placed on the market.
As a result, ingredients with insufficient data packages and for which the
safety is not established shall not be allowed to be placed on the market,
leading to a reduced access to new ingredients and ultimately innovative
products.

1.1.        Subsidiarity

The use of Union competences is governed by
the principles of subsidiarity and proportionality (Article 5 TEU). The current
EU legislation on cosmetics is based on Article 114 TFEU (ex-article 95 TEC)
and its aim is to ensure a high level of protection of human health as well as
the proper functioning of internal market. The Cosmetics Directive/Regulation
exhaustively harmonises rules on consumer safety of cosmetic products placed on
the Community market. Thus, changes to this legal framework can only be
achieved by Community action. The marketing ban directly addresses the free
movement of cosmetic products in the Union. This is already subject to
harmonized legislation and can not be addressed at Member State level. It can
therefore only be achieved at Union level.

2.           Objectives

The general objective is to ensure a proper
functioning of the internal market and maintain a high level of protection of
human health, while paying full regard to the welfare requirements of animals.

The specific objectives followed are
accordingly on the one hand linked to the functioning of the internal market (specific
objectives 1 and 2, Article 114 TFEU) and on the other hand to the animal
welfare objective (specific objectives 3 and 4, Article 13 TFEU):

·
To maintain consumer safety and consumer choice
(specific objective 1 – Consumer Safety and Choice)

·
To maintain innovation and competitiveness of
the European cosmetics industry (specific objective 2 – Innovation and
competitiveness)

·
To provide animals with a high level of
protection and welfare (specific            objective 3 - Animal Welfare)

·
To maintain the incentive for continued research
on alternative methods to animal testing (specific objective 4 – Research into alternatives)

3.           Policy
Options

The policy options discussed in the
assessment are:

Option 1: Baseline/No Action

Under option 1 the Commission would not
make a proposal and the marketing ban would enter into force on 11 March 2013.
The rationale is that this is the most effective way to obtain the overarching
political objective that led to the current provisions – to end animal testing
for cosmetic purposes.

Option 2: Postpone the 2013 deadline

Under option 2
the deadline would be postponed. Three sub-options are considered, to postpone
with a fixed deadline, to postpone in relation to certain endpoints only or to
postpone without fixed deadline. All sub-options follow the rationale to
maintain the overall objective to end animal testing for cosmetic purposes.
They take account of the finding that alternatives are not yet available and
thus make reaching the objective one way or the other dependant on the
availability of alternative methods. Option 2 (a) would postpone the
application of the marketing ban by 7 years, the time by when alternatives at
least for skin sensitisation are expected to be available. Option 2 (b) would
equally postpone the deadline, but would limit the postponement only to those
endpoints most needed to demonstrate the safety of the cosmetic products, ie.
skin sensitisation and repeated dose. Option 2 (c) would foresee a postponement
without a fixed deadline. The ban would apply as soon as alternatives actually
become available. The rationale behind this option is that it would let science
deliver and that it follows a similar logic to those in other regulatory
fields.

Option 3: Maintain the deadline and
introduce an additional derogation mechanism

Option 3 would allow cosmetics and
cosmetics ingredient manufacturers to request a derogation from the marketing
ban for ingredients or combinations of ingredients under limited circumstances.
A derogation would be granted in case the ingredient brings innovation and a
significant benefit to consumer health, consumer wellbeing and/or the environment.
Each case would come under the scrutiny of the Commission and would require weighing
benefits of any new ingredients against the stated objective of ending all
testing of cosmetics on animals. Since it would be a derogation, the cases in
which it would be granted should represent the exception, not the rule.

Manufacturers would also need to
demonstrate that toxicological data needed for the safety assessment is not
available and cannot be obtained using alternative methods to animal testing.
Details on the proposed place of testing, the protocol followed, the number of
animal involved and the animal welfare standards applied must be provided.

The commitment of the manufacturer in
relation to investment in research for alternative methods would need to be
substantited and provisions would be included to avoid duplication of testing.
In terms of procedure, a derogation would be granted in the form of a
Commission Decision, after consultation of the appropriate expertise.

4.           Comparison
of Policy options and the Assessment of their impact

Option 1 would be the most effective of the
options in relation to the animal welfare related objectives. It would end
animal use for EU cosmetic purposes by March 2013. This would mean that a
sub-set of the 15 000 – 27 000 animals estimated to be used for EU cosmetic
purposes outside the EU per year would be spared. Option 1 is expected to
maintain or even increase the current research on alternative methods, simply
because in most cases it will only be possible to bring new cosmetic
ingredients on the market once alternatives are available. It would thus have
effects beyond the Cosmetics legislation and beyond the EU in that it can act
as a critical accelerator in the development of new approaches to human risk assessment.
Specific impacts on consumer safety are not expected from option 1. In case
insufficient data is available for ingredients products containing them cannot
be brought on the market.

Option 1 could however come with certain
negative economic and social impacts. It could lead to a more reduced access to
cosmetic ingredients, since ingredients for which insufficient data packages
exist cannot be placed on the market or may not be able to be defended. This
loss of ingredients and product innovation could lead to a certain loss of
competitiveness of the cosmetics industry. It is estimated by industry
stakeholders that large companies will have an overall significant loss in
turnover and profitability, with losses ranging from 3 to 20% in the short term
(2013-2015), 7 to 20 % in the medium term (2015 – 2018) and 1 to 25% in the
long term (2018 and beyond). Reduced competitiveness could also affect
employment. Industry stakeholders expect a reduction of several thousand
R&D staff, up to 8 000 in the worst case, as well as other staff.

It has to be stressed however that these figures
are estimates from the industry stakeholders. Cosmetic manufacturers that work
under the 'Leaping Bunny' label, thus already now are not relying on animal
testing after certain cut-off dates, consider that the economic impacts could
be positive. The cosmetics industry may also be able to counterbalance these
effects by other approaches to innovation.

Option 2 would be the least effective in
relation to the animal welfare objectives in that it would lead to a continued
animal use for cosmetic purposes. While it maintains the overall objective to
end animal testing, it would postpone ending it beyond 2013. Under option 2 (a)
this would mean a continued use of the 15 000 to 27 000 animals for next 7
years. Under option 2 (b), less animals would be used as the postponement would
not cover certain tests, about 12% less animals are likely to be used. Under
option 2 (c) there would be no fixed end date to the yearly use of 15 000 to 27
000 animals, but numbers would reduce in the future when alternatives become
available.

Option 2 would however have no or very
limited negative economic and social impacts. Under option 2 the current
situation is basically maintained, a situation which has allowed the European cosmetics
industry to be home to some of the most advanced and luxurious cosmetic product
brands and to largely resist the economic crisis.

Option 3 would lead to better impacts for
animal welfare than option 2, but worse impacts than optimal. It would lead to
the possibility to request derogations and, thus, in a number of cases to
testing outside the EU for EU cosmetics purposes beyond 2013. The number of
animals impacted would depend on how often such a derogation would be granted. At
a minimum about 100 animals would be used per derogation. Assuming 10 to 15
derogations would be granted per year this would mean that between 1 000 and 1
500 animals would be used.

As regards the economic and social impacts,
option 3, while leading to a similar situation as option 1, could mitigate the
possible impacts by allowing introducing the most valuable ingredients and
product innovations with particular benefit for consumers. The operational
application of Option 3 would however be challenging, as every single
derogation would require difficult and controversial judgements by the
Commission, in particular whether the potential benefit of the cosmetic would
be significant and hence justify animal tests.

Overall, the quantitative assessment of the
different options faces limitations in relation to the animal welfare
objective, because the total number of animals involved is relatively low in
comparison with other sectors and because the differences in animal use between
the options are difficult to quantify beyond the overall estimates. In relation
to the internal market objectives, while there will be a reduced access to
existing and new ingredients and economic and social impacts are likely to
result from this, they remain extremely difficult to quantify.

All stakeholders concerned share the
overall objective to end animal testing for cosmetics. None of the stakeholders
has an interest in animal testing as such, other than as a tool to ensure and
demonstrate consumer safety. Indeed alternative methods may turn out to be
beneficial for industry.

However, the views of stakeholders voiced
throughout the consultation process on what to do in cases in which
alternatives are not available were split. Animal welfare stakeholders took a
clear position against any proposal in relation to the 2013 deadline, be it a
postponement or the introduction of a derogation mechanism. This position is
based on ethical principles. Industry stakeholders have underlined that they
expect significant negative impacts on availability of ingredients, product
innovation and on their competitiveness from the 2013 deadline and have
therefore overall supported a postponement of the deadline. Industry
stakeholders nevertheless recognised that - as a fall-back position in case the
Commission does not propose a postponement - a derogation will at least allow
access to the most innovative and beneficial ingredients.

Options 1 and 2 do not raise any specific
additional administrative costs for the industry, Member States or the Commission.
Option 3 however does raise administrative costs at industry and Commission
level.

These costs would arise on the industry
side for the preparation and the follow-up of a derogation file and are estimated to be approximately EUR 15 000 per file. In addition,
for each application the company would have to demonstrate financial commitment
in research of alternative methods.

Costs arise also for the Commission, as it would require additional resources to assess derogation
requests. Assuming that about 10 to 15 derogations per year would be dealt with
it is estimated that 2 full time staff would be needed.

5.           Conclusions,
Monitoring and evaluation

The report does not recommend a preferred
option. It recognises that the choice is a political one.

In order to ensure monitoring, the
Cosmetics Directive/Regulation foresees a regular reporting mechanism to the
European Parliament and the Council.

Implementation and enforcement issues will
in addition be reviewed in the various fora already in place, such as the
Cosmetics Committee, the Working Group on Cosmetics and the Platform of
European Market Surveillance Authorities (PEMSAC).

[1]               Council Directive of 27 July 1976 on the
approximation of the laws of the Member States relating to cosmetic products,
OJ L 262, 27.9.1976, p. 169.

[2]               Regulation (EC) No 1223/2009 of the European
Parliament and of the Council of 30 November 2009 on cosmetic products; OJ L
342, 22.12.2009, p. 59

[3]               Report on the Development, Validation and Legal
Acceptance of Alternative Methods to Animal Tests in the Field of Cosmetics
(2009), 13.9.2011, COM(2011) 558 final

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