VERIFICATION REPORT ETV n°160007-RV on … · Adresse : 660 Route de Chaix, 86130 DISSAY, France...

8, allée Geoffroy Saint

Hilaire

CS30021

F-33615 PESSAC Cedex

Tél : (33) 05 47 74 69 00

Fax : (33) 05 47 74 80 13

Mél : [email protected]

http://www.rescoll.fr

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pour

EAB-EWF 515

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EU Environmental Technology

Verification pilot programme

SIRET 437 950 173 00041 – NAF 7490B – VAT FR 81437950173

Accréditation n°3-1004 Portée disponible sur www.cofrac.fr

VERIFICATION REPORT ETV n°160007-RV on

2016/06/02

Subject : ETV Verification report of formulation :

Biofibra® BF-LHE-01

Recipient: FuturaMat

Adresse : 660 Route de Chaix, 86130 DISSAY, France

Contact : Sandra MARTIN

Courriel : [email protected]

Tél : 05 49 89 04 50

Reference : PE/140118/140056/CM/SAU

Order Reference : PE/140118/140056/CM/SAU

Previous report : n.a.

Summary : This verification report presents the results of the assessment and ETV

verification of Biofibra® BF-LHE-01 compound. It also includes all

relevant documents produced during the verification as an annex.

Date of the beginning of the ETV verification : 23/07/2014

Date of the end of the ETV verification : 02/06/2016

Auhor(s) : Verified by : Approved by :

SIGNED

ORIGINAL

SIGNED

ORIGINAL

SIGNED

ORIGINAL

Sandrine AUSSET Claire Michaud José ALCORTA

ETV inspector ETV Technical manager Head of Inspection Department

Use of verification report : The verification report shall not be reproduced except in full, without

the agreement of the verification body and the proposer.

mailto:[email protected]

http://www.rescoll.fr/


RESCOLL FORMULAIRE ETV Code :

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VERIFICATION REPORT sur 37

I. INTRODUCTION ........................................................................................... 4

Name of the product .............................................................................................................. 4

Name and contact of proposer .............................................................................................. 4

Name of Verification Body and responsible of verification ................................................. 4

Organisation of verification including experts, and verification process ............................. 5

Deviations from the verification protocol ............................................................................. 6

II. DESCRIPTION OF THE PRODUCT AND APPLICATION .................. 7

Summary description of the product ................................................................................... 7

Intended application ............................................................................................................ 7

Intend application......................................................................................................... 7

Matrix ........................................................................................................................... 8

Purpose ......................................................................................................................... 8

Technology .................................................................................................................. 8

Technical conditions .................................................................................................... 8

Verification parameters definition ....................................................................................... 9

III. EXISTING DATA ...................................................................................... 10

Accepted existing data ..................................................................................................... 10

IV. EVALUATION ........................................................................................... 10

Calculation of verification parameters ............................................................................. 11

Calculation of biobased carbon content ................................................................... 11

Analyse et mesure de référence ................................................................................ 12

Evaluation of test quality ................................................................................................. 12

Control data .............................................................................................................. 12

Audits ....................................................................................................................... 13

Deviations ................................................................................................................. 13

Verification results (verified performance claim) ............................................................ 13


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Performance parameters ........................................................................................... 13

Operational parameter .............................................................................................. 14

Environmantal parameters ........................................................................................ 14

Additional parameters, with comments or caveats where appropriate ..................... 14

Recommendations for the statement of verification ........................................................ 15

V. QUALITY ASSURANCE ............................................................................ 16

VI. REFERENCES ............................................................................................ 19

VII. ANNEXE 1 : DESCRIPTION GENERALE DU PROCESSUS DE

VERIFICATION ............................................................................................... 20

VIII. ANNEXE 2 : PROTOCOLE D’ECHANTILLONNAGE ................... 20

IX. ANNEXE 3 : FICHE TECHNIQUE ......................................................... 21

X. ANNEXE 4 : RAPPORT D’ANALYSE DE BETA LAB ......................... 22

XI. ANNEXE 5 : RAPPORT D’ANALYSE RESCOLL ............................... 33

XII. ANNEXE 6 : RAPPORT D’ASSURANCE QUALITE DE BETA LAB

............................................................................................................................. 34

XIII. ANNEXE 7 : LISTE DES DOCUMENTS FOURNIS PAR LE

CLIENT .............................................................................................................. 37

XIV. ANNEXE 8 : TERMES ET DEFINITIONS ......................................... 37

XV. ANNEXE 9 : QUICK SCAN - PROPOSITION DE VERIFICATION 37

XVI. ANNEXE 10 : PROTOCOLE DE VERIFICATION SPECIFIQUE . 37

XVII. ANNEXE 11 : RAPPORT PORTANT SUR LES AMENDEMENTS

ET LES DEVIATIONS CONCERNANT LA VERIFICATION ................. 37

XVIII. ANNEXE 12 : PLAN DE TEST (SI APPLICABLE) ........................ 37


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Environmental Technology Verification (ETV) is carried out by a third party to evaluate the

performance of a technology or a product for a given application under specific conditions with

an assurance of the quality of the data.

RESCOLL is a verification body of environmental technology in the field of « materials, waste

and resources », « energy technology » and « water treatment and monitoring ». RESCOLL has

been accredited under ISO 17020 as a type A inspection body by the French Accreditation

Committee (Comité Français d’Accréditation - COFRAC). The accreditation certificate issued

to the audit body by COFRAC ensures that the verification body has the technical competence

and capacity to implement the procedures of the ETV programme for the area of « materials,

waste and resources », « energy technology » and « water treatment and monitoring ». This

certificate also ensures that the quality management system implemented by RESCOLL

complies with the level of quality required by this ETV measure and ensures the reliability of

the results obtained.

Name of the product

Biofibra® BF-LHE-01 by FuturaMat

Name and contact of proposer

FuturaMat, 660 Route de Chaix 86130 DISSAY, France

Contact : Sandra MARTIN

Téléphone : 05 49 89 04 50


Name of Verification Body and responsible of verification

RESCOLL, 8 allée Geoffroy Saint Hilaire CS30021, 33615 PESSAC, FRANCE

Responsable Technique ETV : Claire Michaud

Téléphone : 00 33 (0)5 47 74 69 00 (poste direct 13 52),


Vérificateur ETV : Sandrine Ausset,

Téléphone : 00 33 (0)5 47 74 69 00 (poste direct 13 58),


I. Introduction





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Organisation of verification including experts, and

verification process

The verification was performed by RESCOLL according to the requirements of the General

Verification Protocol (GVP) set out under the European ETV pilot program [EU, 2014]. The

verification process is detailed in appendix 1. The process is based on methods from the GVP

and in accordance to ISO 17020 standard, INS REF 02 and the procedure established by

RESCOLL and its Quality Manuel.

RESCOLL was assisted by an external and technical expert.

The external expert was assigned to provide independent expert review of the specific

verification report and the verification report. The technical expect assigned to this verification

is :

Christine Oberlin (CO), CNRS, Expert Technique ETV dans le domaine des analyses du

carbone 14,

Téléphone : 04 72 43 13 17,


For information purposes, none of step of the verification has been subcontracted.

The tests have been performed by analytical laboratories.

The relationships between the organisations related to this verification and test are given in

Figure 1. An outline of the verification process is described in Tableau 1.

Figure 1 : Organisation de la vérification et des essais



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Responsable Documents

Organisme de vérification Quick Scan

Contrat

Protocole de vérification spécifique

Proposant Sampling

Laboratoires d’analyse Plan de test ou document équivalent

Rapport d’analyse

Organisme de vérification Rapport de vérification

Déclaration de vérification

Tableau 1 : Définition des responsabilités de chaque organisme.

Deviations from the verification protocol

There were no content deviations from the verification protocol. The project was delayed by

more than one year, compared to the verification schedule in the verification protocol. This was

mainly due to find accredited laboratories. The delay did not affect the conclusions of the

verification.

The use of hazardous substance has been defined both as an environmental and additional

parameter. This parameter will be presented as an additional parameter because the percent of

hazardous substances is calculated form information provided by FuturaMat. This change did

not affect the conclusions of the verification.


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Summary description of the product

The formulation developed by FuturaMat named Biofibra® BF-LHE-01 is a biobased

polymer. This formulation is composed of biomass product (for example : wood meal) and

biopolymer (recycled PLA) which are combined with additives and plasticers to functionalise

vegetable fibers. This makes the vegetable fiber and the polymer more compatible. The

composition of this formulation is defined in tableau 2.

Produit Biofibra® BF-LHE-01

Mat

rice

Produit sous forme de granulés

Composition Origine Quantité

CONFIDENTIAL

Tableau 2 : Description de la matière Biofibra® BF-LHE-01

Intended application

Intend application

This compound is used for the manufacture of everyday objects in the field of horticulture,

packaging or for single-use technical components. This compound may be implemented by

extrusion, injection moulding, calendering or thermoforming

II. Description of the product and application


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Matrix

This compound are manufactured form renewable resources. The composition of this

compound is described in

Produit Biofibra® BF-LHE-01

Mat

rice

Produit sous forme de granulés

Composition Origine Quantité

CONFIDENTIAL

Tableau 2.

Purpose

FuturaMat’s objective is to design polymer made from renewable resources wich meet the user

requirements.

All technical charactersitcs of the compound is defined in the technical datasheets (appendix 3)

Technology

The technical principle is derived from the addition of a vegetable filler into a polymer matrix

and from encouraging interaction between the two compounds by functionalisaing fibers while

preventing separations due to the natural incompatibility of the polar vegetable fiber with apolar

polymer. The manufacuring process is defined velow. Yhis process comprises several stages :

Stage 1 : Confidential

Stage 2 : Confidential

Technical conditions

The technical conditions are translated in terms of operational parameters, environmental

parameter and additional parameters. These parameters are detailed in section II.3.


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Verification parameters definition

Performance parameters are based on performance parameters claimed by FuturaMat and on

parameters that include the consideration of regulatory requierements, application based needs,

key environmental factors and state of the art performance of similar technologies.

For the verification of the Biofibra BF-LHE-01 polymer, the performance parameter that has

been defined is :

Biobased carbon content as a fraction of total organic carbon content, expressed as a

percentage of the total organic carbon content.

The biobased carbon content remains constant regardless of the operational parameters. None

of operational parameter has been assessed. However, in order to keep a record of the signature

of this compound, analyses by IRTF spectrometry have been performed on 3 different batches

for the same compound.

Additional parameter that has been defined is :

Mass percent of hazardous substances included in the list of substances subject to

authorization in the annex XIV of the REACH Regulation and in the candidate list for

authorization in the Biofibra BF-LHE-01 compound.


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The following table defines the verification parameters:

Paramètres

Valeurs (Unité) Dispositions

légales en

vigueur

Méthode(s) de test ou de

mesure Données

disponible

PARAMETRES DE PERFORMANCE POUR DETERMINER LA TENEUR EN CARBONE BIOSOURCE

Biobased carbon content

(as a fraction of total

organic carbon content)

% of total

organic carbon

content

none CEN/TS 16 137-

Method C none

PARAMETRE ADDITIONNEL

Mass percent of hazardous

substances included in the

list of substances subject

to authorization in the

annex XIV of the REACH

Regulation and in the

candidate list for

authorization

%

réglement

REACH (EC

No 1907/2006 ;

EU No

848/2012 ; EU

No 1272/2013 ;

EU No

317/2014)

Verification of the

presence of the compounds

constituting the compound

BF-Biofibra LHE-01 in the

list of substances subject to

authorization Annex XIV

of the REACH Regulation

as well as in the candidate

list for authorization

[ECHA, 2016A; [ECHA,

2016B].

none

Tableau 3 : Définition des paramètres de vérification

Accepted existing data

Testing by FuturaMat does not cover the verification parameters. Therfore, no data has been

accepted.

Additional tests have been conducted.

The tests on biobased content and the characterisation of the material by infrared spectroscopy

have been carried out as per the verification protocol.

III. Existing data

IV. Evaluation


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The tests have been carried out in accordance to the verification protocol and CEN/TS 16 137

– Method C : Accelerator Mass Spectrometry (AMS).Beta Analytic laboratory has measured

the biobased carbon content as a fraction of the total organic carbon content.

The characterisation of the production by infrared spectroscopy has been carried out as per the

verification protocol and T 51-500 standard.

The sampling of samples has been carried out by FurutaMat in according to the procedure

detailed in appendix 2. The sampling has been carried out during the production cycle and under

production when the blend was homogenous in compliance with the recommendation of the

verification protocol.

Calculation of verification parameters

Calculation of biobased carbon content

The biobased carbon content as a fraction of total organic carbon content of Biofibra® BF-

LHE-01 has been measured on 3 samples from the same batch. The batch reference analyzed

is BP 11122 FG which was produced on 02/05/2011. The test reports are available in appendix

4.

The biobased carbon content as a fraction of total organic carbon has been calculated according

to CEN/TS 16 137 standard with the following formula :

𝑥𝐵𝑇𝑂𝐶 = 𝑝𝑀𝐶 × 0,98

with,

𝑥𝐵𝑇𝑂𝐶 : the biobased carbon content by total organic carbon content, formulated percentage of

total organic carbon content, assuming that 100% corresponds to the set of total organic carbon

in the sample.

𝑝𝑀𝐶 : percent modern carbon, value obtained directly to the amount of biomass derived carbon

in the sample according to the AMS method.

0,98 is the correction factor.

The averaging of the biobased carbon content by total organic carbon fraction has been

calculated with the following formula :

𝑥 = ∑ 𝑥𝑖

𝑛𝑖=1

𝑛

Avec 𝑥 : average, n : number of tests and xi : the value of the test i.


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The standard deviation of the biobased carbon content as a fraction of total organic carbon

content has been calculated with the following formula :

𝜎 = √∑ (𝑥𝑖 − 𝑥)2𝑛

𝑖=1

𝑛 − 1

Avec 𝜎 : standard deviation, 𝑥 : average of the values, n : number of test et xi the value of the

test i.

Analyse et mesure de référence

The infrared spectrum of Biofibra BC-LHE-01 compound has been analysed for 3 different

batches. The spectrums are available in appendix 5. The following table lists the number of the

batches characterized by FTIR.

N° de lot

Date de prélèvement lors de la production

N° report

Essai 1 BF 11122 FG

02/05/2011

BA 161345 du 10 mars 2016

Essai 2 BF 16028B/290116/MG/MG

29/01/2016

BA 161343 du 10 mars 2016

Essai 3 BF 16028D/020216/MG/MG

02/02/2016

BA161344b du 5 avril 2016

Tableau 4 : n° des lots analysés en infra rouge

There was no production of the Biofibra® BF-LHE-01compound between 2011 and 2016. This

explains why the FTIR analyses were performed on a compound produced in 2011 and two

compounds in 2016.

Evaluation of test quality

Control data

Beta Analytic laboratory is accredited according to ISO/IEC 17025 in United States by Perry

Johnson laboratory to CEN/TS 16137 Appendix D- Method C. The reports are issued under

accreditation.

RESCOLL laboratory is accredited to ISO/IEC 17025 by COFRAC to T51-500. The reports

are issued under accreditation.


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Audits

Beta Analytic Laboratory :

Beta Analytic laboratory is accredited according to ISO/IEC 17025 for the tests performed

(acceditation n° 59423, certificat n° L14-353 delivered by PJLA). It therefore meets the GVP

requirements. A test system audit by RESCOLL is not necessary. The audit is reduced to

verifying the existence of accreditation certificates and the presence of laboratory accreditation

« Perry Johnson Laboratory Accreditation » amoung members of ILAC Mutual Recognition

Arrangement.

In terms of the test performance audit and test system control, the reports have been submitted

with the mention « ISO/IEC 17025 : 2005 Accredited Testing Laboratory - Testing

Accreditation PJLA #59423 » which confirms that the service has been performed within the

accreditation scope. This certifies the performance of the test.

In addition, Beta Analytic sends a quality assurance report associated to each sample. This

report provides the results of reference materials used to validate radiocarbon analyses prior to

reporting. These reports are available in appendix 6. The audit is consisted in verifying the

quality assurance reports. All these informations certifie the performance of the tests.

RESCOLL Laboratory :

RESCOLL laboratory is accredited according to ISO/IEC 17025 for the tests performed

(accreditation n°1-1995 delivered by le COFRAC). It therefore meets the GVP requirements.

A test system audit by RESCOLL is not necessary. The audit is reduced to verifying the

existence of accreditation certificates

In terms of the test performance audit and test system control, the reports have been submitted

with the logo of the accreditation body which confirms that the service has been performed

within the accreditation scope. This certifies the performance of the test.

Deviations

None of deviation has been observed compared to specific verification protocol

Verification results (verified performance claim)

Performance parameters

The results of the analyses of the biobased carbon content as a fraction of total organic carbon

content ( 𝑥𝐵𝑇𝑂𝐶) are described in the following table :


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N° de lot

Sampling date

N° laboratoire Beta Lab 𝑥𝐵𝑇𝑂𝐶

(%)

Essai 1 BF 11122 FG

02/05/2011

Beta-426008 100

Essai 2 Beta-426013 100

Essai 3 Beta-428001 99

Average 100

Standard deviation on average 1

Tableau 5 :Résultats des analyses pour la mesure de la teneur en carbone biosourcé.

Performance parameter is listed in the following table :

Paramètres Performance vérifiée Commentaires

Biobased carbon content as a

fraction of total organic carbon

content (expressed as a percentage

of the total organic carbon content)

100 % Average of 3 tests

Standard deviation :+0% / -1%

Tableau 6 : Paramètre de performance du compound BioFibra BF-LHE-01

Operational parameter

None of operational parameter has been verified.

Environmantal parameters

None of environemantl parameter has been verified

Additional parameters, with comments or caveats where

appropriate

The substances used in the compound BF-Biofibra LHE-01 are not included in the list of

substances subject to authorization Annex XIV of the REACH Regulation and in the candidate

list for authorization.

CONFIDENTIAL


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Composé Numéro

CAS

N°

d’enregistrement

REACH

Pourcentage de

la quantité

utilisé par unité

de produit

Confidential Not listed




Tableau 7 : liste des composés utilisés par FuturaMat pour la formulation du compound BF-LHE-01

The additional parameter is listed in the following table:

Paramètres Valeur Commentaires

Mass percent of hazardous substances included in

the list of substances subject to authorization in the

annex XIV of the REACH Regulation and in the

candidate list for authorization contained in BioFibra

BF-LHE-01

(This parameter is based on information on the

composition of the compound provided by

Futuramat)

0 %

Verification of the presence of the

compounds constituting the

compound BF-Biofibra LHE-01 in

the list of substances subject to

authorization Annex XIV of the

REACH Regulation as well as in

the candidate list for authorization

[ECHA, 2016A; [ECHA, 2016B].

Tableau 8 : Paramètre additionnel du compound BioFibra® BF-LHE-01

Recommendations for the statement of verification

The proposer shall make the statement available in full and shall not use parts of the statement

for any purpose.

It is recommended that the statement of verification is based on the values described in section

IV.3. Verification parameters state in the statement of verification will be :

Paramètres Performance vérifiée Commentaires

Biobased carbon content as a

fraction of total organic carbon

content (expressed as a percentage

of the total organic carbon content)

100 % Average of 3 tests

+0% / -1%

Tableau 9 : paramètre de performance du compound Biofibra BF-LHe-01


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Additional parameter will be :

Paramètres Valeur

Mass percent of hazardous substances included in the list of

substances subject to authorization in the annex XIV of the REACH

Regulation and in the candidate list for authorization contained in

BioFibra BF-LHE-01

(This parameter is based on information on the composition of the

compound provided by Futuramat)

0 %

Tableau 10 : Pourcentage de substance dangereuse classé. Ces résultats sont issus de données fournies par

FuturaMat et de données bibliographiques.

FuturaMat may quote the Statement of Verification as follows in part B.VIII.1 of GVP.

La déclaration de vérification est retirée par RESCOLL en cas d’utilisation abusive par le client.

Une utilisation abusive est définie comme une violation des conditions de vérification du

programme pilote ETV de l’UE. En cas de retrait, la déclaration de vérification et le rapport ou

des parties du rapport sont supprimés du site web.

Il est interdit d’utiliser le logo ETV seul, sur des produits, sur des publications (imprimés,

internet ou autres) autres que la déclaration de vérification. Néanmoins, le logo ETV peut être

utilisé sur des publications en mentionnant la référence de la déclaration de vérification,

conformément aux recommandations précisées dans le GVP et du guidance document 006- Use

of the ETV logo and post-verification requirements when marketing a technology verified

through the ETV scheme en cours de rédaction. Le logo peut être utilisé dans la limite où les

résultats de la vérification ETV sont correctement traduits dans la publication et en évitant toute

confusion sur la technologie approuvée.

The quality assurance principles in all the verification, test and analyses are presented in the

figure below.

V. Quality assurance


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Figure 2 : Assurance qualité lors des étapes de la vérification

As part of this verification, only analytical laboratories have be part of the verification.


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The quality assurance is described in the following table

Organisme vérificateur

RESCOLL

Proposant Expert

Externe

Initiales

(Fonction)

CM

(RT)

SAU

(V)

SA

(RQ)

JA

(R)

Comité

d’inspection

FuturaMat CO

Etapes

Protocole de

vérification

Examine et

approuve

Rédige Examine Participe à la

rédaction

Examine

Plan de test Approuve Examine Approuve Examine et

approuve

Système de

test

(performance

et gestion de

la qualité

Audit

Rapport de

test

Examine Examine

Rapport de

vérification

Examine et

approuve

Rédige Examine et

approuve Examine et

approuve Examine et

approuve Examine Examine

Déclaration de

vérification

Rédige Examine et

approuve

Approuve Examine

Tableau 11 : Personnel intervenant lors de la vérification ETV. RT : Responsable Technique, V : Vérificateur,

RQ : Responsable Qualité, R : Responsable département Inspection.

The internal document review has been conducted by the technical head of ETV

Test system audit are conducted by the quality manager

The tests have been conducted by accredited laboratories according to ISO 17025.

The specific verification protocol and the verification report have been reviewed by an external

and technical expert

The verification report has been reviewed by the inspection comitte.

The verification body has reviewed and approuved the test plan and reviewed the test report.

An internal audit has been done by internal auditor of RESCOLL on the inspection process.


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[ASTM D6866] ASTM D6866

Standard Test Methods for determining the biobased content of solid, liquid, and

gaseous samples using radiocarbon analysis.

[ASTM D7026] ASTM D7026

Standard Guide for Sampling and Reporting of Results for Determination of Biobased

Content of Materials via Carbon Isotope Analysis

[CEN/TS 16137, 2011] CEN/TS 16137

Plastiques - Détermination de la teneur en carbone biosourcé

2011

[EU, 2014] European Union

EU Environmental Technology Verification pilot programme.

General Verification Protocol.

2014.

[T 51-500, 1989] T 51-500

Plastiques – Résines thermodurcissables – Analyse par spectrophotométrie infrarouge.

Décembre 1989

VI. Références


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VII. Annexe 1 : Description générale du

processus de vérification

VIII. Annexe 2 : Protocole d’échantillonnage


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IX. Annexe 3 : Fiche technique


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Rapport N° Beta-426008

X. Annexe 4 : Rapport d’analyse de Beta Lab


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Rapport N° Beta-426013


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Rapport N°Beta-428001


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CONFIDENTIAL

XI. Annexe 5 : Rapport d’analyse RESCOLL


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Rapport N° Beta-426008-QA-34857

XII. Annexe 6 : Rapport d’assurance qualité de

Beta Lab


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NA

XIII. Annexe 7 : Liste des documents fournis par

le client

XIV. Annexe 8 : Termes et définitions

XV. Annexe 9 : Quick Scan - Proposition de

vérification

XVI. Annexe 10 : Protocole de vérification

spécifique

XVII. Annexe 11 : Rapport portant sur les

amendements et les déviations concernant la

vérification

XVIII. Annexe 12 : Plan de test (si applicable)

VERIFICATION REPORT ETV n°160007-RV on … · Adresse : 660 Route de Chaix, 86130 DISSAY, France...

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