EB 8048-2 EN 14-5
SAMSON REGULATION S.A.S. · 1, rue Jean Corona · 69120 Vaulx-en-Velin, France · samson@samsongroup.com 3
EU DECLARATION OF CONFORMITY
For the following product 2021-09
Angle Valve Type 3349
The Aseptic Angle Valve Type 3349 meets the requirements of the food and pharmaceutical industry.
The valve components in contact with foodstuffs meet the following requirements:
- the metal parts (valve body and plug) are made of forged stainless steel 1.4435/316L in accord-
ance with:
o the French decree of 13 January 1976 on stainless steel materials and objects in contact
with foodstuffs;
o the sheet published by the French authority DGCCRF: MCDA n°1 (V2 - 2017), Aptitude
for food contact of metals and metal alloys intended to come into contact with foodstuffs.
- The diaphragm, which ensures the seal with the outside, is made of PTFE:
o Our supplier's declaration of conformity certifies that this material complies with regula-
tions (EC) No. 1935/2004
4
and (EU) No. 10/2011
5
as amended and is manufactured in
accordance with the good manufacturing practices established by regulation (EC) No.
2023/2006
6
;
o The conditions and results of the overall and specific migration tests are detailed on the
next page.
- The optional valve seals, which provide the internal seal, are made of PEEK Natural Food & Life
Science Grade:
o Our supplier's declaration of conformity certifies that this material complies with regula-
tions (EC) No. 1935/2004
4
and (EU) No. 10/2011
5
as amended and is manufactured in
accordance with the good manufacturing practices established by regulation (EC) No.
2023/2006
6
;
o The conditions and results of our supplier's global and specific migration tests are availa-
ble on request.
According to the migration tests carried out on the plastic components in accordance with Regulation
(EU) No 10/2011 as amended, the overall and specific migrations remain within the limits set by the
above-mentioned Regulation when the complete apparatus is used under the conditions indicated below:
- for all foodstuffs specified due to the satisfactory results obtained with simulants A, B and D2 (Annex III
Tables 1 and 3);
- under the conditions covered by the tests: applications at a maximum temperature of 121°C (according
to Annex V Chapter 3 Table 3).
4
Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food
5
Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food, as last amended by Regula-
tion (EU) No 2020/1245
6
Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food
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