Montag, 21. Juli 2014

Nachricht von der EU Kommission

Nachricht der EU Kommission vom 15.7.14
Betrifft: petition Nr. 18331 20L3 (Nummer bitte bei jedem Schriftverkehr angeben.)

Sehr geehrte Frau Urban,
zuerst möchte ich Ihnen herzlich danken für Ihre Teilnahme an unsere Sitzung vom 1. April
2014, in der der Petitionsausschuss die Prüfung Ihrer Petition begonnen hat, unter
Berücksichtigung der schriftlichen und mündlichen Informationen der Kommission. Zu lhrer
Information lege ich eine Kopie der schriftlichen Antwort der Kommission bei.

Im Anschluss an seine Beratungen beschloss der Ausschuss, die Kommission um weitere
Auskünfte zu ersuchen. Der Ausschuss wird die Prüfung Ihrer Petition fortsetzen, sobald er die erforderlichen Informationen erhalten hat.
Ich werde Sie selbstverständlich über alle weiteren Massnahmen im Zusammenhang mit Ihrer Petition auf dem Laufenden halten.

Mit freundlichen Grüssen
Erminia Mazzoni

Der Anhang in englischer Sprache:
Subject: Petition 1833/2013 by Gisela Urban and Gabriele Menzel (German), on
behalf of several animal protection associations, bearing 7724 signatures, on
animal testing and the REACH Regulation
l. Summary of petition
The petitioners urge the European Parliament and the European Commission to stop the
Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals
(REACH). Under this Regulation all chemicals, also those already available before the entry
into force of the Regulation, must be tested according to a uniform standard. The petitioners
claim that millions of animals suffer a cruel death in tests of highly toxic chemicals because
of this Regulation and consider it unethical to continue this massive animal testing. Animals
are living beings capable of feeling pain, fair and suffering. The petitioners claim that
scientists are expressing doubts about the usability of results from animal testing, and that
enormous amounts of data on chemicals are already available which should be used and
evaluated before any animal test is proposed. Also there are reliable alternatives to animal
testing. According to the petitioners the REACH Regulation has an alibi function. It relieves
politicians and businesses from their responsibility because they have met the standards also.
it deceives the customer in that he is told that all this is done to protect him, whereas - as the
petitioners claim - the contrary is the case because testing toxic substances on animals is
completely unsuitable for predictions on reactions in humans. The only reason animal testing
is continuing is that the scientific world has been using this method for so long. The
petitioners call on politicians to listen to the European citizens and stop animal testing once
and for all.
2. Admissibility
Declared admissible on 6 February2 014. Information requested from Commission under Rule 202(6).
3. Commission reply, received on 30 April 20L4
The petitioner requests the European Parliament and the Commission to stop the European
Chemicals legislation REACH as in their view it is in contradiction to European legislation on
the protection of animals used for scientific purposes (Directive 86l609lEEC, now replaced by
Directive20l0/63/EU), and does not fulfill its aim of protecting human health. The petitioners
also ask for central collection of existing toxicity data for chemicals, the exclusive use of
alternative methods and increased public funding for the development and validation of in
vitro tests.
Commission observations
In a recent representative Eurobarometer survey regarding the attitudes of EU citizens
towards the environment, citizens identified as one of their top concerns the impact of
chemicals used in everyday products on their health.
The REACH Regulation was developed because a large number of substances has been
manufactured and placed on the market in Europe for many years, sometimes in very high
amounts, and yet there was insufficient information on the hazards that they pose. There was
a need to fill these information gaps to ensure that it is possible to identify the hazards and
assess the risks presented by these substances, and to put in place the necessary risk management measures in order to protect human health and the environment.
On the other hand, the petitioner refers to a (non-representative) internet consultation by the
European Commission showing that European citizens do not support animal testing.
Any legislation needs to strike a balance between such diverging societal needs and interests and REACH, while ensuring the protection of human health and the environment, gives full consideration to animal welfare aspects. The EU legislation on the protection of animals used for scientific purposes (Directive No 20101631EU) requires that the use of experimental animals is limited to the minimum necessary and restricted to cases where no scientifically satisfactory alternatives are available. This principle is a central element of the REACH regulation which contains extensive provisions designed to minimise animal testing. As a general rule, REACH requires that animal testing be used only as a last resort, in cases when there is no scientifically reliable way of showing the impact of a chemical on human health and the environment without resorting to in vivo tests. Information on the toxicity of
chemicals must be generated whenever possible by means other than testing on vertebrate
animals, i.e.:
- Use of existing data: REACH does not necessarily require new testing of chemicals
that are already on the market. REACH aims to collect all existing information on
chemicals, and even if tests have not been carried out in accordance with current
standards, their results can be used as long as they are considered to provide adequate
- Data sharing: REACH obliges registrants for the same substance to share existing or
newly generated data in order to avoid repeat testing for the same substance.
- Use of non-testing approaches: REACH provides for the use of non-testing approaches
which use available information on related substances to draw conclusions on a
substance under evaluation (e.g. analysis of chemical structure to deduce certain
toxicological properties ("Qualitative or Quantitative Structure-activity relationship
models"), grouping of substances likely to have similar properties and use of
information on some substances to predict toxicity of others in the same group).
- Use of in vitro methods: If sufficient information cannot be obtained by the means
described above, any new testing must use in vitro methods wherever suitable methods
are available.
Only if, after exhausting these possibilities, it is still considered that no conclusion on the
toxicity of a substance can be made, should additional testing on animals be considered. For
higher tier tests (repeated dose toxicity, reproductive toxicity), registrants need to submit a
testing proposal to the European Chemicals Agency (ECHA), which will check, before
approving the proposal, that no useable data exists from other sources and that the proposed test is appropriate to fill the data gap.
The Commission closely monitors the functioning of these provisions. Reports on the use of
alternatives to testing on animals under the REACH Regulation are issued by ECHA every
three years, starting in 201 I on the basis of data from the first REACH submission deadline in 2010. The next report will be published in June 2014.
The 2011 report confirms that the above measures are working to limit the need for animal
testing. By far the main source of submitted information is existing data from studies that
were conducted prior to REACH. Data sharing is used in 90oÄ of dossiers received by the
first submission deadline in 2010. Also, registrants submitting data for the first REACH
deadline made extensive use of these possibilities to filI data gaps, especially in order to avoid higher tier studies (e.g. long term animal tests). The report also shows that, compared to previous estimates relatively few new studies have been conducted for REACH (1850 invivo studies), and that in vitro alternatives are being increasingly used for the endpoints where such methods are available (i.e. skin/eye irritation). Also, the number of testing proposals submitted (ca. 700) for higher tier animal studies was lower than expected. Preliminary data for the 2014 report indicate that these trends will be confirmed by the second report. These first analyses indicate that the Commission estimates of the potential of alternative
approachest o reduce the amount of animal testing required under REACH were realistic and
that the total number of animals used for toxicological testing under REACH is very likely to
be significantly below the assumptions made during the development of REACH. These
results prove that the figures sometimes circulated in the press (e.g. the 50 million animals
cited in the petition) were based on inaccurate calculations.
In addition to monitoring the use of alternatives for REACH purposes, the Commission
collects statistical data on the number of animals used for experimental and other scientific
pu{poses in the Member States of the European Union and presents a Report on the use of
animals for scientific purposes to the Council and the European Parliament every 3 years.
A comparison of the data obtained for the years 2005,2008 and 2011 shows that the number
of animals used in toxicological testing in categories relevant for REACH (i.e.
products/substances used or intended to be used mainly in industry and in the household)
constitutes only a small proportion (less than | %) of the overall use (the main uses being in
fundamental biology studies and research and the development of medicines). The number of animals used for these purposes did not increase, but rather declined, between 2005 and 2011 despite the introduction of REACH.
The petitioner claims that already today, sufficient alternatives are available to abolish
chemical testing on animals entirely and that animal test results are not relevant for safety
assessment for human health.
Any toxicological testing required under REACH and other regulatory frameworks has to be
done in accordance with internationally agreed and accepted test methods. This ensures that
data on chemicals can be consistently interpreted and compared. Up to the present, safety
assessments of chemicals have been based essentially on animal studies, for which there is a large body of experience and historical control data. It is well recognised in the toxicological
field that animal tests have certain limitations, and that results may not in all cases be easily
extrapolated to the human situation; nevertheless, results from animal experiments are
generally considered to give a good indication of the hazards of a chemical substance.
However, contrary to the view expressed in the petition, it is not generally accepted in the
scientific Community that alternatives can completely replace toxicological testing at present.
Validated and accepted in vitro test methods do exist already for some endpoints, and it is
expected that more methods (e.g. for skin sensitisation) will become available. However,
many methods are still in the research stage and, especially in relation to the more complex
endpoints, a recent report by the European Commission's Joint Research Centre showed that, in several important toxicological areas, no methods will be available in the near future to predict toxicity solely on the basis of in vitro testing. Therefore limited animal testing will
still be necessary for some time to ensure the protection of human health and the environment from harmful chemicals. This sentiment is echoed in Directive 20l0/63/Eu which
acknowledges (in recital l0) the continued need to use live animals to protect human and
animal health and the environment.
Toxicogenomic approaches, which are given particular emphasis in the petition, are a
promising methodology with the potential to further reduce animal testing and save time and
costs, and they may play an important role as a building block in chemical safety assessments.
However, they have not yet been developed to a point where they can be used routinely in
regulatory safety testing.
The petition calls for increased public funding for the development and validation of non animal testing. Following its commitment to reducing refining and replacing animal tests, the Commission is already closely involved in the development, validation and promotion of the use of alternatives under its legislation. The European Centre for the Validation of
Alternative Methods (ECVAM) is the leading player in method validation in the EU.
Moreover, the Commission has invested about 200 million Euros in research of animal-free
toxicology under Framework Programme 7 and will continue these efforts in the forthcoming
research programme, Horizon 2020.
REACH is crucial to the effective protection of European citizens and the environment from
the impact of potentially hazardous chemicals. It fully respects the societal attitudes underpinning Directive 2010/63/EU and its laudable ambition to limit animal testing to the
absolutely minimum necessary. Early indications are that the various measures put in place in REACH to ensure that progress is made towards this goal are working, and that the number of animal tests required under REACH is well below initial estimates.
Although the availability of in vitro methods capable of replacing established animal tests is
continuously increasing, sound chemical safety assessments are not yet possible solely on the basis of non-animal data, so that limited and targeted toxicological testing on animals will still be required in the near future.

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