NEWS

EuGH-Urteil zu SVHC in Erzeugnissen

September 2015

Die REACH-Verordnung verpflichtet Hersteller, Importeure und ggf. Händler zu Kommunikations- und Meldepflichten zu besonders besorgniserregenden Stoffen (SVHC) in Erzeugnissen. Der Europäische Gerichtshof (EuGH) hatte darüber zu entscheiden ob die dabei anzuwendende Konzentrationsgrenze von 0,1% auf das Gesamterzeugnis (z.B. Auto) oder auch auf Teilerzeugnisse (z.B. Autofelge) anzuwenden ist. Der EuGH hat entschieden, dass die Pflichten auch für Teilerzeugnisse gelten, die selber die Erzeugnis-definition erfüllen. Das Konzept, welches u.a. Deutschland vertritt, ist unter dem Titel „Einmal ein Erzeugnis - immer ein Erzeugnis“ („Once an article – Always an article“) bekannt. Mit diesem Urteil werden die Infor-mationsrechte für Unternehmen und Verbraucher gestärkt.
Voraussetzung für diese Pflichten ist, dass die besonders besorgniserregenden Stoffe nach dem in der REACH-VO vorgesehenen Verfahren identifiziert und in die Kandidatenliste aufgenommen wurden. Dies erfolgte bisher für 163 Stoffe. Die Pflichten bestehen nur, wenn ein besonders besorgniserregender Stoff in einer Konzentration von mehr als 0,1% im Erzeugnis vorkommt.

Chemical Safety: REACH

Die Erweiterte Ein-Generationsstudie (OECD 443) ist von der ECHA als Standardanforderung anstelle der Zwei-Generationsstudie (OECD 416) anerkannt worden. Die Kosten für die komplette Studie liegen bei ca. 750.000 Euro. Daher ist es wichtig für Registranten, nur die notwendigen Teile dieser Studie durchführen zu müssen. Dabei hilft BTO.

Nur wenige Laboratorien sind derzeit in der Lage diese Studie fachgerecht durchzuführen. BTO vermittelt gerne Kontakt zu kompetenten Labors.


Die Studie auf Embryotoxizität (OECD 414) wird mittlerweile in der Regel für zwei Spezies gefordert. BTO berät bei der Argumentation, diesen Endpunkt auf eine Spezies zu beschränken.


Progress in the use of alternatives to animal testing

 

ECHA/PR/14/10 

 

Helsinki, 2 June 2014 - ECHA's second report to the European Commission on the use of alternative methods under REACH shows an increase in the use of these methods. The report's analysis is based on over 38 000 registration dossiers submitted for the 2010 and 2013 registration deadlines.

 

According to the report, most registrants do conform with the data sharing obligation under REACH to fulfil the information requirements and to avoid unnecessary animal testing. Registrants also built categories and predicted substance properties using read-across approaches in up to 75 % of analysed dossiers for at least one endpoint. Read-across or category approach has been particularly used for higher-tier endpoints where alternative, non-animal test methods are not yet available.

 

In addition, registrants started to take up in vitro methods for skin and eye irritation, using cells, tissues or organs. The total number of in vitro studies submitted for skin and eye irritation has tripled since 2011: almost 20 % of analysed dossiers contained them for these endpoints.

 

So far, ECHA's database contains information on 7 939 new experimental studies for those endpoints which may involve vertebrate animal testing. Out of these, 4 887 are tests on vertebrate animals and 3 052 are in vitro tests.

 

During the analysis, ECHA found that 293 tests were conducted on vertebrate animals without a prior submission and approval of a proposal for testing, as required by REACH. Registrants have obligation to include higher tier studies even if they were conducted for e.g. other regulations and therefore ECHA's decision requesting the study may not have been required. ECHA is further analysing the cases to establish the possible reasons. ECHA will inform Member State Authorities on the final results of this further analysis so they can take the next steps they consider to be appropriate.

 

Testing on vertebrate animals is only allowed as a last resort under REACH and ECHA's objective is to promote non-animal testing methods and other alternatives. Every three years, ECHA reports to the Commission on how the alternative methods have been used to generate information on intrinsic properties of chemical substances and for the risk assessment. The next report is due in 2017.

 

ECHA will use the results of the report to promote the use of alternative methods in support of registrants aiming for the 2018 registration deadline

 

ECHA's second report to the European Commission on the use of alternative methods under REACH:

http://echa.europa.eu/documents/10162/13639/alternatives_test_animals_2014_en.pdf

 

Animal Numbers 2012

Comment on

The Number of Animals used for Scientific Purposes in the Federal Republic of Germany in 2012

 

The numbers of animals used for scientific purposes in Germany is rising steadily year after year and reached in 2012 an all time high of 3.080.727 animals. The increase in the animal number is mainly due to new research possibilities offered by genetically modified (GM) animals and harmful mutants (HM), predominantly mice. Transgenic animals represent already about 30% (933.853) of the all experimental animals in Germany (compared to more than 50% in the UK).

 

Rodents together with rabbits represented 90.71% of the total animal number. The second most used group of animals were birds and cold-blooded animals as reptiles, amphibians and fish with 8.19%. The horses, donkeys and crossbreeds, pigs, goats, sheep and cattle represent 0.86%, carnivores 0.13% and non-human primates 0.06% of the animals used in 2012.

 

More than 37% of animals were used in fundamental biology studies, 23% in research, development, production and quality control of products and devices in human medicine, veterinary medicine and dentistry.  Furthermore, 29% were sacrificed for scientific purposes without detailled definition what those animals are finally used for. For education 2% of the animals had been needed in 2012. Only 5.4% (166.716 animals) had been required by laws and directives for toxicological safety testing in Germany. A marked decrease in absolute as well as relative numbers could be observed over the last four years, despite additional testing requirements by the REACH legislation (Table 1).

 

=====================================================

Table 1: Number of animals used for toxicological safety testing from 2009 to 2012

 

     2009

     2010

     2011

     2012

Total animal number

2.786.331

2.856.316

2.911.705

3.080.727

Incl. Tox      absolute

201.512

173.851

174.656

166.716

                     relative

7.23%

6.24%

6.00%

5.40%

=====================================================

 

This positive result is likely to be attributed to the great efforts undertaken to reduce and replace animal studies in toxicology by alternative test methods and integrated testing strategies during the last 25 years. Unfortunately, this could not be proven by the statistics in its present form, which gives a total number of animals per endpoint only. Recommendation: An update of the statistics requirements in the European Union should include the number of tests done for each toxicological endpoint differentiated according to the kind of test and the respective animal number. An example is given in Table 2.  

 

================================================== 

Table 2: Statistics modified as recommended:

             Endpoint “Reproductive Toxicity” 

 

# Tests OECD 421/422

# Animals 421/422      

 

 

# Tests OECD 415

 

# Animals 415

 

 

# Tests OECD 416

 

# Animals 416

 

 

# Tests OECD 443

 

# Animals 443

 

 

Total number of tests

Total animal number

 

 

14867

 ==================================================

 

More sophisticated statistics would help to focus the resources of research and development of alternative methods more effectively and to further decrease the number of animals in toxicology. It is gratefully acknowledged, that Germany is supporting development of alternative methods to animal experimentation during several decades. Recommendation: The time has come, to concentrate financial support on the implementation of (pre-)validated replacement methods into regulatory practice, preferably for acute/subacute toxicity and toxicity to reproduction. In this sense, reorganisation of funding would be an attractive task for the new German Government as well as for the other EU member states and the EU Commission.

 

Besides further scientific action in the scope of toxicological safety testing, experimentation for other purposes, “consuming” most of the animals, must be urgently restricted by politics in the EU. Recommendation: As a first step, it would be a demonstration of political intent to stop use of animals in trainings and exercises. Furthermore, experimentation on primates, dogs, cats, and horses should be banned immediately.

 

A proper scientific assessment of proposals for animal experiments would automatically decrease the animal number and improve the quality of research. Recommendation: Competent authorities and centers like ZEBET in Germany should be enabled to evaluate the scientific as well as the legal part of experimentation proposals. After minor rearrangments of the existing institutions, special staff should be available for their only task: assessing service for animal experiment proposals.

 

Some of the above recommendations may not really be new. All the more they should be accomplished right now in responsibility for the natural basis of life and the animals which both is national goal determined in the German Grundgesetz (national constitution).

 

Deutsche Version

 

Product Safety: Cosmetics

Seit dem 11. März 2013 dürfen Kosmetika und deren Inhaltsstoffe in der EU nicht mehr im Tierversuch getestet werden. Von diesem Testverbot gibt es Ausnahmen.  Neue Produkte, für die Tierversuche durch-geführt werden, dürfen in der EU nicht verkauft werden. Dieses Marketingverbot betrifft allerdings nicht die Produkte, die sich bereits auf dem Markt befinden.

Die International Cooperation on Cosmetics Regulation (ICCR) hat am 26.11.2013 eine Liste von validierten Alternativen zum Tierversuch publiziert, die allerdings nicht vollständig ist.

 

Product Safety: RAPEX

The rapid alert system for non-food dangerous products (RAPEX) was established by the EU to facilitate the exchange of information between Member States and the Commission on measures taken to prevent or restrict the marketing or use of products posing a risk to the health and safety of consumers as well as to other public interests with the exception of food, pharmaceutical and medical devices, which are covered otherwise.

http://ec.europa.eu/consumers/safety/rapex

 

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