Samson 3349 Mounting And Operating Instructions page 81

Aseptic angle valve with usp-vi diaphragm, valve with pneumatic actuator and positioner, valve combined with pneumatic piston actuator and positioner
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DECLARATION OF CONFORMITY
Regulation (EU) No. 1907/2006 (REACH, Registration, Evaluation, Authorisation and Restriction of
Chemicals); United Nations Globally Harmonised System (UN GHS); and WFD, Waste Framework
Directive (EU) 2008/98/EC, Article 9(1)(i) as amended by Directive (EU) 2018/851 of 30 May 2018, and
their national implementations
_____________________________________________________________________________
We hereby certify that we are well informed about the REACH regulation, which entered into force on 1 June
2007 and have determined the applicable consequences and obligations, especially pre-registration and
registration of substances, notifications to public bodies, authorization, and restriction. We manufacture "arti-
cles" as defined in the REACH Regulation Article 2. As a result, we are a "downstream user" in most cases.
We do not produce any substances or mixtures that we sell.
Concerning the registration of the relevant substances we use to manufacture our products, we can inform
you based on REACH Article 10 that, on the basis of the information presently available to us, we do not
currently reach the threshold of one ton per year. It is possible for us to provide more precise data if re-
quired.
Concentration of SVHC (substances of very high concern) in SAMSON Products
We have a duty to communicate information to our customers on substances contained in our products ac-
cording to Article 33 of the REACH Regulation: SAMSON calculate the contents of the substances in every
individual article (e.g. nuts, bolts etc.) included in a bill of materials separately, following the judgment by the
Court of Justice of the European Union concerning case C-106/14 of 16 October 2015, "Once an article,
always an article" (O5A). SAMSON refer to a Candidate List of SVHC, that lists up the substances that we
report:
These substances are often determined based on the classification of chemical substances and mixtures in
the United Nations Global Harmonized System (UN GHS). We implement these systematics in Europe by
following the Regulation (EC) No. 1272/2008 (CLP) on classification, labeling and packaging of substances
and mixtures, forming a unified approach with the REACH Regulation. Both Safety Data Sheets (SDS,
MSDS) for chemicals and chemical mixtures as well as SAMSON Material Data Sheets (MDS) for declaring
a material and its substance content are prescribed by these regulations, based on an official list:
Compliance with the Candidate List of SVHC for Authorisation
Should you need to make reference to the most recent list, kindly see to the version published on the Inter-
net, with the latest SAMSON references. Go to the following website to check whether the duty to communi-
cate information according to REACH Article 33 applies to a SAMSON product:
https://www.samsongroup.com/en/about-samson/material-compliance/reach-regulation/#c2723
Also, we frequently cite further SVHC details on the delivery papers.
The Candidate List according to Article 59 (1, 10) of Regulation (EC) No. 1907/2006 (REACH) was first pub-
lished on 1 September 2008. Since then, it is constantly expanded every six months by the European Chem-
icals Agency (ECHA). The Candidate List is regularly updated around the middle and end of every year. It
now comprises of over 200 substances:
https://www.echa.europa.eu/web/guest/candidate-list-table
As a result, it is an on-going process to check whether our products contain SVHC in a concentration greater
than 0.1% (w/w). We are in close contact with our suppliers as part of this process and we will inform you if
we discover that any changes apply to us.
SAMSON REGULATION S.A.S. · 1, rue Jean Corona · 69120 Vaulx-en-Velin, France · samson@samsongroup.com
EB 8048-2 EN
(in English).
DC007
2021-12
1
14-7

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