Engineering plastics – The Manual - F.wood-supply.dk

Certifications and approvals
To ensure that our products comply with the latest valid
standards and regulations, a thorough working knowledge
and continuous checking of the relevant rules and regulations
is essential. It is the task of our Product Compliance
Management Department to ensure that our products comply
with these rules and to provide you with the relevant
certifications.
Food approvals
Materials which come into direct contact with food must be
produced in accordance with the principles of good manufacturing
practice in such a way that they do not give off any
of their constituent parts to the food under normal or foreseeable
conditions which could pose a threat to human
health.
Ensinger supplies materials which form the basis for a
wide range of different products and processing applications.
In some cases, these in turn require approval by the
relevant regulatory bodies. The Ensinger product portfolio
contains materials with a variety of different approvals,
which include the following areas:
ˌˌDirect food contact
(in compliance with FDA, BfR, 10/2011/EC, 1935/2004/
EC 2002/72/EC, 3A SSI amongst others)
ˌˌBiocompatibility (in accordance with ISO 10993, USP
Class VI amongst others)
ˌˌDrinking water contact (including KTW, WRAS, NSF61)
ˌˌFlammability (including UL94, BAM)
ˌˌRestriction of Hazardous Substances
(RoHS amongst others)
ˌˌOther approvals
This stipulation is defined in food regulatory standards and
safeguarded by means of tests, controls and stipulations.
Significant institutions in this field are the FDA (Food and
Drug Administration) in the USA, the BfR (Federal Institute
for Risk Assessment) in Germany and the EFSA (European
Food Safety Authority) for the EU. Particular focus is
on the EU regulations (1935/2004/EC, 10/2011/EC, …).
Ensinger offers a broad portfolio of plastics from stock
which comply with the requirements for direct food contact
as stipulated by BfR, FDA and EU regulations.
For detailed information please refer to our
brochure "Plastics used in food technology"
at www.ensinger-online.com
Working in close cooperation with our raw materials suppliers,
authorities and institutes, we check the possible approvals
and ensure, by using methods such as regular material
tests, that the manufactured products comply, to as
great an extent as possible, with the relevant regulatory requirements.
Depending on the material involved, we offer to issue the
listed confirmations relating to the materials from our supply
range if these are required by customers. In the interests
of ensuring seamless traceability, these confirmations
are only issued by Ensinger in direct connection with an
actual order and with the material supplied. This minimizes
the risk of nonconforming special-purpose products being
inadvertently issued with certifications and gaining access
to the market, as could occur if we permitted
uncontrolled downloading of certificates from our website.
Special attention is currently being paid to approvals in the
food and medical technology sector. Due to the strict regulations
applicable to these areas of application, they deserve
particular mention.
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