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: J- N& r' O5 d3 t& S- D+ [http://www.zls-muenchen.de/de/le ... legungen_090505.pdf
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New PAK document ZEK 01.1-08 | 25.06.2008 |
" v) U! ]$ w8 }. A7 i2 hThe document of ZEK 01,1-08 replaces the document of ZEK 01-08 with publication date. & T7 o, h x5 M+ e
Substantial contents of the past document were not changed (e.g. requirements of products, the testing method, PAK maximum values etc. which can be kept). . @" o1 N( z. s
Changes of editorial kind were essentially made as well as on the homepage of the ZLS in connection with the document of ZEK 01-08 valid publications and/or clarifications were considered. : D* \9 W( q P0 I8 I- v& F4 k; _
, p+ `; @* N: l5 `* CThe following changes were in detail made:
* v. W& Q7 X4 I/ a | With the term „“now expressly „technical media and consumer products “are meant product. : ]7 D) b5 b: Y* x
+ x7 S+ t2 X1 O | | Clearer structure
9 s# {; M2 n* `The structure of the PAK document was restructured. A procedure is to be kept, which plans an endangerment evaluation as the first step. Subsequently, takes place the categorization, which was called in the past document as the first and from there to misunderstandings led. To be evaluated in the last step the examination (EN) to be made and their results are.
8 [% O; F$ p/ T8 j; d+ hAdditionally supplementing references to the endangerment evaluation and categorization of a product/a product group by the exchange of experience circle as well as to the use from already available test reports were taken up. + v* h5 c* m$ u( E' v- m3 n
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| | The temporary agreements to existing and new certificates, specified on the homepage, were integrated. In particular a temporary agreement was considered, which refers to certificates, whose monitoring rotation amounts to two years.
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% D9 j1 H9 m( T8 o# H! _! J6 c | | The testing method was supplemented around contributions, which describe the procedure for matrix problems. ( `' F+ c: B: |6 `+ X4 y
2 t: x. L) |, A' X* S1 m) Q, o | | From the table in category 1 the purchase too „materials, in contact with food stand “, due to more exact regulations in the LFGB painted. In all other respects the reference takes place that parts (surface, construction units, building groups, materials etc.) of the product are excluded from the application of the PAK document, if resembles and/or large legal regulations exist to PAK in products. " y$ r3 l! R* f! }$ Z4 o6 J: r3 T
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Important information for the conversion of the PAK document ZEK 01-08
8 n. e* a5 d) ^, \in connection with other legislation, in particular food rightImportant information for the application OF the PAH document ZEK 01-08 issued by the cent ral Experience Exchange Committee (ZEK) in connec tion with more other legally requirements, in particular food law
( p8 c9 \6 g0 o; w, n' v" @ | 08.05.2008 |
/ C6 g+ j( H" n8 r( y R! cIn the PAK document ZEK 01-08 in table 1, category 1 on materials, which are located in contact with food, purchase is taken.
( o! @! O @+ n7 ~, {5 iIn particular for these materials there are large speciallegal regulations (e.g. consumer article, food and animal feed law book (food and animal feed law book - LFGB)). If materials are subject to other legislation, then these are valid in place of the regulations, which are made in the PAK document. - v! ]5 P0 D; D' [( s
Here it is to be noted that the exception is valid only for the individual material, the construction unit and/or the building group and not for the entire product. Materials and parts of the product, which are not seized by the other legislation, are to be evaluated in the context of the gs indication awarding procedure according to the defaults of the PAK document.
. {/ m/ _- g8 c8 Q' s8 lExample: water-prominent parts in coffee machines, those in contact with food (e.g. ) Stand for water, etc., are subject for the other legislation LFGB and are thus exceptional from the application of the PAK document. Grasp surfaces of the coffee machine must be evaluated however further according to the requirements of the PAK document.
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Question for the application of the PAK resolution during new exhibition of an existing gs indication certificateQuestion referring ton the application OF the PAH Decision into case OF rice south OF A gs Mark of Certificate , j- F* y; T# i, w
| 05.05.2008 | 2 U# u: m: }: i, m
Is the examination of a product for that a valid gs indication certificate already exists in accordance with the requirements of the PAK resolution immediately and always necessarily, if the gs indication certificate is again issued? " f3 y4 P" q( l( W- k4 ^( }. @
The following approach was specified:
5 c0 U$ M% O0 F8 V. XAn immediate consideration is not immediately necessary during the new exhibition of a gs indication certificate already existing in the following reasons:
; J: X+ u2 G9 Y; j' K: k C. zIn the case of change of the company name usually new gs indication certificates are issued. Since the product does not change however constructionally as well as concerning other characteristics and it more or less concerns during the new exhibition of the gs indication certificate a pure formality, a consideration of the requirements of the PAK resolution is only necessary during the production plant monitoring which can be accomplished.
3 s. d% p5 p, P' ]# K! e(Consider: By the new exhibition of the gs indication certificate the periods for the execution of the control measures for the production of the product, already specified, do not change.)
# Y, n+ z3 c* [5 USame is valid in similar way with the removal of the gs indication certificate owner, if the product does not change concerning all characteristics and is necessary no additional examination in terms of safety of the product. 0 o4 l+ _4 Z" Y: X! O
For range of the secondary certificates (OEM certificates) the v. G. procedure can be likewise used. In these cases an examination is in accordance with the defaults of the PAK document at the latest up to the next control measure for the production of the product in accordance with the periods „of the main certificate already specified “and/or up to 31. To accomplish March 2009 compellingly. Over it going out monitoring intervals are not permissible in these cases.
& y* S9 P& g: g' @Regarding the OEM certificates and thus also for „the main certificates “the PAK document - as fixed - to at the latest 31 must. March 2009 to be used. , W# ~$ w: N9 i, q- x+ N
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Important information for the conversion of the PAK document ZEK 01-08 | 20.03.2008 |
" i0 j1 H# H4 K& HDue to complaints PAK document above mentioned over different approaches with application we refer to the following: . `) a* C9 m9 q/ |$ d) ]" Q
The document can cause due to its structure to a misinterpretation and thus a biased error in application. 3 k/ Z& D! `- i1 K* ?
Fundamental first a risk analysis is to be accomplished and documented appropriately by the certified places. On the basis the result is to be made then for the relevant (seizing) surfaces in accordance with categorization the document. 3 d9 h' y) m3 D( n. S
According to categorization proofs are to be furnished and/or accomplished examinations. The entire procedure is to be documented in the context of the gs indication awarding procedure.
9 ~; P8 u( ^$ k5 I: P- s/ k' |! XIn order to emphasize above mentioned procedure more clearly, an editorial change of the ZEK document 01-08 is intended as follows and immediately applicable:
+ B8 Z4 R# T) Q$ h9 u" f6 w[li]In order to ensure a uniform and appropriate procedure during the gs indication awarding, all freely accessible surfaces should not generally be examined. Intention of the document is it that actually only relevant (seizing) surfaces are regarded. It is not goal-leading, „to security “all product parts or - surfaces of examining.
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[/li][li]For the relief of the definition, which (seizing) must be regarded surfaces, the exchange of experience circles are to compile a common approach/categorization (product group specific). 6 k% ^! b5 t3 |
: P) p3 S3 E1 Q: O[/li][li]Still if no approach/categorization is certain, or concerns it a special case for a product/a product group, then is to be proceeded on the basis a risk analysis.
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Application of the PAK requirements ZEK 01-08
: n; ?; M/ [5 R ~0 n. T0 ~Application OF the PAH requirement | 04.02.2008 | ! M3 E" ]! C" N6 }, h
Effects on the validity of gs certificates
# P' K6 q& c- R: k( l(Existence, current and future certification procedures)
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Examination and evaluation of polycyclischen aromatic hydrocarbons (PAK) during the gs indication awardingTesting and Assessment OF PAH for gs certification * N3 k& [; U$ d- s: _& u
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The committee for technical media and consumer products decided to 20.11.2007 the obligatory inclusion of the examination on PAK into the gs indication assignment. So far examinations and evaluations could be accomplished by PAK voluntarily and without reference to the gs character.
( p% y1 T) u7 {: ^7 @+ iThe necessary document was revised after the defaults of the AtAV resolution and with today's date is published (document of ZEK 01-08). After a transition period the new test specification will have obligatory to be used starting from 1 April 2008 on all gs places. / n; w9 W7 w7 @9 H9 {9 }; c" j
The test specification contains also a harmonized testing instruction for all gs test laboratories. It possible does not made only resemble test conditions, but also examination in line with standard usage and a fast on PAK to examining samples. / j4 k/ b7 |2 o/ B/ B0 F
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In arrangement with Bundesinstitut for risk evaluation (BfR) at the time of the execution of analytics of the PAK resolution ZEK 01-08 is recommended to consider the following addition: Addition ZEK 01-08
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: O X8 g% P* g- q5 O% l1 m9 B2 M3 ~New accreditation ranges of the ZLS | 26.11.2007 |
) ` K0 s0 i2 YThe list of the accreditation ranges replaces those past to term pyramid.
. i' I+ a: r5 W) z+ N4 |! OYou find this list under demand documentation of the certified places and the certified supervisory bodies.
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4 j8 K* U G0 ]Please use for the definition of the requested accreditation extent exclusively
2 K9 f* Q, J4 m( S/ Pthe list of the accreditation ranges
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B6 ?( O2 r% J" w# z+ U8 RCertified supervisory bodies 1 ]7 {6 u7 ]1 ^( ?
- Statistics of the accomplished examinations 2007 - | 26.10.2007 | 9 g% W/ R( w# w
Please convey to us up to 31.01.2008 a statistics of your 2007 as ZÜS accomplished examinations. Examinations, which were accomplished by officially recognized experts, are not to be listed. ! g/ I6 B" ?8 \, o+ T8 y
3 K6 n1 ]- e* \' @Please use for this attached form.
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! V: Z: I( B& ]: q" M# W/ ]* yNew standard for certification bodies of quality assurance systems
' D. P$ n6 C0 p2 j$ I- Plan for the introduction/conversion DIN EN ISO/CInternational Electronical Commission 17021 - | 02.10.2007 | ) I* x$ d- M" ]% u/ ^/ H3 K
For the proof of the introduction and conversion of the DIN EN ISO/CInternational Electronical Commission 17021, as replacement for the DIN EN 45012, at the latest by 15 September 2008 the plan can be loaded here for the introduction/conversion DIN EN ISO/CInternational Electronical Commission 17021 down. On the basis this plan the ZLS examines the conditions of the conversion in the context of monitoring investigations.
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7 F0 a5 T+ h0 z# D1 eExamining and evaluating Polyzykli aromatic hydrocarbons (PAK) # x8 X& E4 k) L( H2 a) v
(k) a problem for gs places…?! | 24.05.2007 | - @5 H; I6 M% J4 x/ c" b3 s8 A
Due to missing laws the members have centers of the exchange of experience circle (ZEK) a uniform procedure of the certified places with the sampling, measurement and evaluation of polyzyklischen aromatic hydrocarbons (PAK), which in technical media and consumer products be contained can, decided (document of ZEK 06-07). ( w; \' \$ {# V
Here it concerns for the time being a voluntary examination, which is not a component of the examinations in the context of the gs indication assignment. / p L2 R; k' ?+ S- A6 K2 ? U0 p
The resolution became to 22. May 2007 by the committee for technical media and consumer products (AtAV) confirms. This has lively that Bundesinstitut for risk evaluation delivers a statement to the resolution, whether the suggested measures are sufficient. % |4 b2 ?+ k$ [9 W Y
On basis of this statement the AtAV can decide whether the evaluation of the PAK becomes obligating. + f9 j) H1 q' e( S5 t
A long-term goal should be it that the PAK problem is equally treated by the member states of the European Union. S, F0 F' m9 l1 `6 B4 z
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New standard for certification bodies of quality assurance systems (central quality comittee) DIN EN ISO/CInternational Electronical Commission 17021:2006 | 05.04.2007 |
: h+ }% z$ N j! ^" DThe DIN EN 45012, in which the general were fixed requirements in places, which examine and certify quality management systems, was replaced by the DIN EN ISO/CInternational Electronical Commission 17021:2006. The transition period was specified by international resolutions on two years after the date of the publication as ISO standard. That means that the past accreditations on the basis of the DIN EN 45012 until at the latest 15. September 2008 by the DIN EN ISO/CInternational Electronical Commission 17021:2006 to be replaced must.
e# I: k* s' Z ] } xSince also the accreditation places need a certain time for this conversion, the ZLS becomes after a conversion phase all places, which request central quality comittee
* d2 D* b8 |' J! }starting from 1 January 2008 accredit 17021:2006 according to the DIN EN ISO/CInternational Electronical Commission. The accordingly changed documents, like demand documentation, are e.g. published in time in the homepage of the ZLS.
$ u/ J0 {# g/ X6 q1 KAll places, which cannot over an ZLS accreditation after 45012 be ordered and in the framework by repetition accreditations by 15 September 2008 to the 17021 be changed over, must fulfill nevertheless at the latest at this time the requirements the 17021:2006. These places are written down from there of the ZLS and requested, the ZLS a plan with the necessary measures for the fulfillment of the 17021:2006 to submit. The ZLS will examine the conversion of this plan by 15 September 2008. ! V& m6 D# {/ G- f4 P
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Working comitee market monitoring (AAMÜ):
6 R- t3 c2 |. lNo gs character of tools such as drills and saw blades | 01.03.2007 |
1 y* I* D( s. S( m+ C/ OAn inquiry of the professional association tool industry to the AAMÜ led to the following definition:
# f! l8 Z$ P. R( _$ zDue to § 7 of the equipment and product safety law (GPSG) the attachment of gs characters - so far according to regulation determined § 3 nothing else - is possible only at technical media and use-finished utensils.
6 S- E9 C, f& DFor consumers and usually in the trade available tools such as drill and saw blades determined are no technical media. Rather it concerns here utensils, which however use are not and from there also not with the gs character will provide may. 7 s% K5 ^2 n( [ Z. N" ^
With the discussion of the question in the AAMÜ the representative of the Federal Ministry for work and social pointed out that this topic was to be considered during the next revision of the GPSG with. A temporal default for such a revision does not give it however yet. 8 @0 H0 K( H' m9 H& [: `
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Regulation on certified supervisory bodies (ZÜSV Hessen) of the Federal state Hessen | 22.01.2007 |
7 b x% r; t+ h. ^+ O c9 OAbove mentioned regulation stepped to 01.01.2007 into force. Certified supervisory bodies, which were accredited and designated for the Federal state Hessen, to have the obligations of the certified supervisory bodies after § 2 above mentioned regulation to consider. 1 J( J& G: i3 o2 D( L9 N
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