as at: 23rd February 2016

Elastomer Guideline Extended

Transitional Rule for Part 2 of the
Positive List of Starting Substances
Only the German version is legally binding.

Necessity to extend the transitional period

The Elastomer Guideline of the German Environment Agency

(Umweltbundesamt - UBA) published in 2011 stipulates that the starting
substances, used for the production of elastomers, should be assessed
according to the principles of the European Food Safety Agency EFSA,
applicable for the authorization of starting substances for the production
of plastics in contact with foods.

The Elastomer Guideline of 22 December 2011 contains a positive list

consisting of two parts. Part 1 contains starting substances that have been
assessed. Part 2 of the positive list contains starting substances not yet
fully assessed. The manufacture of elastomers using only the substances
listed so far in Part 1 is not possible. For this purpose, also starting
substances listed in Part 2 are absolutely required. Therefore, the
Elastomer Guideline has stipulated a transitional rule stating a period
until 31 December 2016 for these starting substances to be assessed
toxicologically by this deadline. To this purpose, manufacturers are
required to file applications for substances to be included in Part 1
according to the rules of procedure for maintaining the positive list of
starting substances for organic materials, and to submit the documents
required to UBA for assessment.

For several reasons, UBA has so far received only a few applications for
the assessment of starting substances. Meanwhile, a number of activities
have been initiated by the Wirtschaftsverband der deutschen
Kautschukindustrie e. V. (wdk, association of the German rubber industry)
and the Bundesvereinigung der Firmen im Gas- und Wasserfach e. V.
(figawa, German federal association of companies in the gas and water
supply industry) to remedy this situation. However, by the date of the
German Environment Agency
present publication, none of the starting substances from Part 2 of the Section II 3.4
positive list could be transferred to Part 1 so far. Actually, this would Heinrich-Heine-Straße 1
mean that from 1 January 2017, no elastomers would be available based 08645 Bad Elster
on the positive list of 22 December 2011. To avoid this situation and
www.umweltbundesamt.de
enable a subsequent assessment of substances listed in Part 2 of the
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 positive list, the transitional period for the use of substances from Part 2 of
the positive list are extended after consulting the manufacturers’
associations. In this way, manufacturers who buy and use elastomer components for their
products (e.g. O-rings for use in fittings) will have sufficient time to adjust their products to
the use of components made from other elastomers.

Extended transitional rule

Test certificates for products from elastomers based on the Elastomer Guideline whose
formulations contain starting substances listed in Part 2 of the positive list can be issued
beyond the date of 31 December 2016 until 31 December 2021 at the latest, or extended to
this date.
Hence, the starting substances listed in Part 2 can be used until 31 December 2021 in the
sense of the Elastomer Guideline.

Test certificates awarded on the basis of the old KTW Recommendation 1.3.13 cannot be
extended further.

Necessity of assessment of all starting substances

UBA recommends that applications for new substances to be added to Part 1 and for
substances to be transferred from Part 1 to Part 2 of the positive list should be filed according
to the rules of procedure.

UBA is prepared to consider the further approach for the assessment of the starting
substances listed in Part 2 of the positive list on the basis of migration tests and additional
information submitted.

Therefore, UBA recommends that all elastomer mixtures employed for the production of
elastomer components to be used in contact with drinking water should be recorded by the
manufacturers who buy such components, and their associations, respectively (e.g. figawa,
Verband Deutscher Maschinen- und Anlagenbau e. V. (VDMA – the German Engineering
Federation)), in cooperation with the elastomer manufacturers, which are organized e.g. in
the wdk. This is to ensure a cooperation of all actors of the industry concerned along the
supply chain.

In cases where exemplary migration tests are carried out for elastomer mixtures and the
results are submitted to UBA by 31 December 2016, UBA will consider whether an assessment
of individual substances listed in Part 2 of the positive list is possible based on the
information available in order to enable a transfer of such substances to Part 1.

The migration tests have to be carried out according to the provisions of the Elastomer
Guideline. The migration waters have to be tested for the starting substances, their possible
impurities and reaction products. In these tests, also screening methods (e.g. GC-MS and LC-
MS) have to be used in order to demonstrate that no unintended substances migrate to the
drinking water.
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 For the decision on the further approach in the assessment of substances of Part 2, UBA
requires further data on the products used presently and the substances from Part 2 of the
positive list involved. Such data include information on the actual use of the products in
water distribution systems and information on the formulations, in order to be able to assess
the migration test results. Therefore, the companies and associations involved are asked by
UBA to make available also the information listed in Tables 1 and 2 of the Annex.

Award of test certificates

Products assessed by means of this transitional rule of the Elastomer Guideline can be
awarded a test certificate entitled „ Test certificate according to the transitional rule of the
Elastomer Guideline".
Test certificates with a limited term until December 2016 based on the former provisions can
be extended to max. 5 years after the date of issue.

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Annex
Table 1: Information on the use of the different elastomer materials

Manufacturer Name of the Rubber type Type of Use in water distribution (see Annex 5 to Type of test certificates (a, b or c)1
elastomer cross- the Elastomer Guideline)
mixture linking
Company A XYZ EPDM peroxidic Seals for pipes ID < 80 mm

1 There are three types of test certificates:

a) Test certificate on the basis of the withdrawn KTW Recommendation 1.3.13
b) Test certificate in accordance with the Elastomer Guideline, manufactured with substances from Part 2 of the positive list
c) Test certificate in accordance with the Elastomer Guideline, manufactured exclusively with substances from Part 1 of the positive list

Table 2: Information required to assess the migration results

Elastomer Glass Type of Substance Quantities commonly used/ Possible migration Physicochemical
material temperature cross-linking from Part 2 concentration in final product known properties 2

2 For example water solubility, octanol-water partition coefficient, molecular weight