acknowledgements and authorizations

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ACKNOWLEDGEMENTS AND AUTHORIZATIONS

ISO 17025:2005

All laboratories within the Mérieux NutriSciences network are in compliance with ISO 17025:2005. The 5 laboratories in Italy are accredited by Accredia.

 Bergamo (0144 B) Micro analysis in food and pet food. First accreditation 2000.

Lusciano - Naples (1025) Micro analysis in food. First accreditation 2010.

 Prato (0144 A) Micro, chemical – physical, biochemical, nutritional, microscopic and sensory analysis for food.

First accreditation 1997).

 Priolo Gargallo (0953) Chemistry analysis in environmental samples. First accreditation 2009.

Resana (0051)

Micro, chemical - physical, biochemical, nutritional, GMO, microscopic analysis in agriculture, food, environment,

detergents, cosmetic, food contact material, industrial hygiene. First accreditation March 1993.

ISO 9001:2008 CERTIFICATION

Certification of the Quality Management System in compliance with the UNI EN ISO 9001:2008 standard granted by

CERTIQUALITY ( certificate nr. 2171 ) for the following activities in Resana (n. 2171) “Planning and provision of chemical, physical and microbiological analysis, research and technical- scientific services for industrial, craft, trade and service enterprise” (1 st certification June 1999). The certification is valid inside the IQNet circuit ( certificate nr. It-6915 ). Prato lab is granted by CERTITALIA (n.B06109-R1)

“Design and provision of services related to chemical, physical and microbiological analysis ”. (1 st certification Dic 2009).

ISO 14001:2004 CERTIFICATION

Certification of the Environmental Management System; it refers only to the following site: Via Castellana 118/A,

Resana and is in compliance with the Standard UNI EN ISO 14001:2004 granted by CERTIQUALITY ( n. 10899 ) for the following activities “Only for sampling services and technical-scientific assistance for industry, agriculture and environment”

. First certification July 2006. The certification is valid inside the IQNet circuit ( certificate nr. It-41432 ).

REGISTRATION IN THE REGISTER OF RESEARCH LABORATORIES

Registration in the register of research laboratories according to art. 14 of D.M. 593 of 08/08/2000 (prot. nr. 55 of

01/04/2002, Italian Ministry of Instruction, University and Research Decree of 12/27/2001). (Resana lab).

APPROVED ORGANISATION CARRING OUT R&D ACTIVITIES FOR THE ACCOUNT OF PRIVATE COMPANY

FOR THE RECOGNITION OF THE FRENCH CREDIT D'IMPOT RECHERCHE (CIR)

Inclusion in list of approved organisations carrying out R&D activities by the French

Ministère de l'Enseignement supérieur et de la Recherche, Direction générale pour la recherche et l'innovation, for the recognition of the "Crédit

Impôt Recherche – CIR" ( Décision d'Agrément 16/09/2013

).

FOOD

APPROVED LABORATORIES THAT PERFORM ANALYSIS FOR SELF-MONITORING PLAN

 Bergamo: registration in the Lombardia Regional Register (valid on Italian territory) of the laboratories that perform analysis requested by the self-monitoring plan procedures in the food industry according to L. 9/266

14/7/2010. Registration number: 030016301009).

Lusciano: registration In the Campania Regional Register (valid on Italian territory) of the laboratories that perform analysis requested by the self-monitoring plan procedures in the food industry according to D.D.R.

6010/05/2013. Registration number: 100 CE.

 Prato: registration in the Toscana Regional Register (valid on Italian territory) of laboratories performing analysis requested by the self-monitoring plan procedures in the food industry according to D.R. 3001

03/07/2008. Registration number: 016.

Resana : registration In the Veneto Regional Register (valid on Italian territory) of the laboratories that perform analysis requested by the self-monitoring plan procedures in the food industry according to L. 07/07/2009 nr.

88. First registration: decree nr. 366 on 02/ 08/2005 of the General Prevention Direction according to D.L.vo

26/05/1997 nr. 155, current registration: decree nr. 37 on 16/04/2015 . Registration number: 7.

Chelab Silliker - a Mérieux NutriSciences company.

Head office: Via Fratta 25, 31023 Resana, Italy. Phone. + 39 0423.7177

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REGISTRATION IN THE ITALIAN MINISTRY OF AGRICULTURE, FOOD AND FORESTRY POLICIES REGISTER

OF LABORATORIES WHICH PERFORM ANALYSIS FOR ORGANIC FARMING PRODUCTS

Registered in the list of the Italian Ministry of Agriculture, Food and Forestry Policies as a laboratory approved to perform analysis of samples from organic farming in accordance with Article12of Regulation (EC) No. 882of 29

April2004 and subsequent amendments and additions ( Resana and Prato sites )

REGISTRATION IN THE ITALIAN MINISTRY OF HEALTH REGISTER OF LABORATORIES WHICH PERFORM

PESTICIDES, NITRATES AND NITRITES TESTING ON FRUIT AND VEGETABLES FOR THE EXPORT TO RUSSIA

The list of the authorized laboratories is available on the following link: www.salute.gov.it/

QS - FACHGESELLSCHAFT OBST-

GEMüSE-KARTOFFELN GmbH APPROVAL

The Resana and Prato labs have been acknowledged by QS

– Fachgesellschaft Obst-Gemüse-Kartoffeln GmbH - as laboratory authorized for the monitoring of residues on fresh fruits, vegetables and potatoes in the QS quality system

Prato first acknowledgment 2006, certificate nr. 401743 . Resana first acknowledgment August 3, 2007, certificate nr.

402097 .

EDEKA APPROVAL

Resana laboratory has been acknowledged by EDEKA as laboratory authorized for the monitoring of residues on fresh fruits, vegetables and potatoes and for the recording of the data in the I-monitoring database. The list of the laboratories is available in the website www.fruitmonitoring.com/it/laborliste.html

FRUIT MONITORING

Prato and Resana are authorized by the Fruit Monitoring system to perform pesticide residues on fruit and vegetables commercialized in Germany. The list of laboratories is available in the website www.fruitmonitoring.com

AUTHORIZATION TO PERFORM OFFICIAL ANALYSIS ON WINES AND WINE EXPORTATION

Authorization from the Italian Ministry of Agricultural and Forest Policies to perform official analysis on wines and to issue analysis certificates for wine exportations according to the Italian and Community regulations. Authorization from Ministry of Agricultural, Food and Forest Policies Decree of 14/03/2013 . Resana lab.

AUTHORIZATION TO PERFORM OFFICIAL ANALYSIS ON OIL

Authorization from the Italian Ministry of Agricultural and Forest Policies to perform official analysis on oils, according to the Italian and Community regulations. Authorization on Ministry of Agricultural, Food and Forest Policies Decree of

14/03/2013 . Resana lab.

AUTHORIZATION FOR ANALYSISON MEDICATED FEED

Authorization from the Italian Ministry of Health to perform quantitative and qualitative analysis on medicated feed according to the Decree of 11/16/93 (prot. nr. 600.9/24315/AG117L/ 21/2602 of 11/30/1995). Resana lab.

AUTHORIZATION FOR ANALYSISON FAT CONTENT IN MILK

Authorization of Veneto Region for analysis on fat content in milk for quality payment purpose, according to

Circ. Nr. 5 of 03/20/93 (prot. nr. 9320/40142 of 09/21/1993). Resana lab.

ASSOBIRRA AUTHORIZATION

Beer and Malt Industry Association (ASSOBIRRA) authorization for conducting quantitative PCR analysis on corn and for traceability for GMO-free corn. Resana lab.

REGISTRATION IN THE LIST OF LABORATORIES RECOMMENDED BY AIC

Registration in the list of the laboratories recommended by the Italian Celiac Association (AIC) to detect gluten in food.

Resana lab. List of the laboratories AIC .

REGISTRATION IN THE LIST OF LABORATORIES AUTHORIZATED BY FACE (Federacion de Asociaciones de

Celiacos de Espana)

Registration in the list of the laboratories authorized by the Spanish Federation of the Celiacs Association (FACE) to detect gluten in food. http://www.celiacos.org

. Resana lab.

REGISTRATION IN THE LIST OF COOP ITALIA LABORATORIES

Registration in the list of the COOP ITALIA authorized laboratories for the execution of microbiological analyses, dioxin research, GMO analyses, pesticide analysis, migrations analysis in packaging and foods, analysis of nitrates, analysis of mycotoxins, analysis of allergens, analysis of aromatic polycyclic hydrocarbons, analysis of heavy metals. Resana and

Prato lab.

Registration COOP Italia laboratories .

REGISTRATION ICA

Registration in Colombia as a Quality Control Laboratory of Agricultural Bioproducts, to determine free amino acids in

Chelab Silliker - a Mérieux NutriSciences company.

Head office: Via Fratta 25, 31023 Resana, Italy. Phone. + 39 0423.7177

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raw material and formulated product by the Instituto Colombiano Agropecuario (ICA), through the resolution 000939, dated April 11, 2012. Resana. Registration ICA .

REGISTRATION IN THE LIST OF JAPANESE MINISTRY OF HEALTH FOR ANALYSYS OF FOOD EXPORTED IN

JAPAN

Registration in the list of Japanese Ministry of Health (through the Italian Ministry of Health) for analysis of food exported in Japan.Resana registration number IT10052, Prato and Bergamo registration number IT10431.

QUALIFIED LABORATORY FOR ITALIAN NATIONAL PROGRAMME FOR SALMONELLOSIS (PNCS)

According to what is stated in the note 0025886-09 / 12/2014-DGSAF-COD_UO-P of the Italian Ministry of Health, the site of Resana has been recognized as qualified by the Ministry of Health to perform the analysis of samples from the

2015 PNCS . The laboratory has been included in the list of private laboratories suitable, available in the public part of the webportal www.vetinfo.sanita.it ->sezione zoonosi ->piani salmonellosi - >Identificazione laboratory private che intendono eseguire le analisi dei campioni prelevati dagli OSA (PNCS).

APPROVED ORGANISATION CARRING OUT R&D ACTIVITIES FOR THE ACCOUNT OF PRIVATE COMPANY FOR

THE RECOGNITION OF THE FRENCH CREDIT D'IMPOT RECHERCHE (CIR)

Registered in list of approved organisations carrying out R&D activities by the french Ministère de l'Enseignement supérieur et de la Recherche, Direction générale pour la recherche et l'innovation, for the recognition of the "Crédit Impôt

Recherche

– CIR" (Décision d'Agrément 16/09/2013)

PHARMACEUTICAL

INSPECTED, ACCEPTED AND REGISTRED BY FDA

Resana laboratory is registred by FDA as Outside Testing Facility engaged in control activities for dosage forms and active ingredients release. Last FDA inspection January 2014. Establishment Inspection Report,

January 27-28, 2014; FEI 3009859065 .

Resana.

QUALITY CONTROL LABORATORY AUTHORIZATION FOR HUMAN MEDICINAL PRODUCTS

Authorization by the Italian Competent Authority (AIFA) as independent Contract Research Organization which performs

Quality Control Testing (microbiological, chemical/physical and biological) of human Medicinal Products, Investigational

Medicinal Products for human use and active pharmaceutical ingredients ( authorization nr. aM –21/2013 ). Resana.

GMP CERTIFICATE

Authorization by the Italian Competent Authority (AIFA) under the national inspection program in connection with manufacturing authorization n. aM

–21/2013 in accordance with art. 40 of Directive 2001/83/EC. The GMP certificate states that our laboratories complies with the Good Manufacturing Practice (GMP) requirements referred to The principles and guidelines of GMP laid down in Directive 2003/94/EC ( certificate nr. IT/61-1/H/2013 ). Resana.

QUALITY CONTROL LABORATORY AUTHORIZATION FOR MEDICINAL PRODUCTS FOR VETERINARY USE

Authorization by the Italian Ministry of Health as Contract Quality Control laboratory for microbiological, chemical/physical and biological testing of Medicinal Products and active pharmaceutical ingredients for veterinary use . Authorization

N./14/2011/V . Resana.

GMP CERTIFICATE

Authorization by the Italian Competent Authority under the national inspection program in connection with manufacturing authorization N./14/2011/V in accordance with art. 44 of Directive 2001/82/EC. The GMP certificate states that our laboratories complies with the Good Manufacturing Practice (GMP) requirements referred to in The principles and guidelines of GMP laid down in Directive 91/412/EC ( certificate nr. NBF/4/2015/V ). Resana.

QUALIFICATION AS LABORATORY INVOLVED IN CLINICAL TRIALS (BIOANALYTICAL PART OF

BIOEQUIVALENCE TRIALS AND PHASE-I CLINICAL TRIALS) OF MEDICINAL PRODUCTS by the local health authority (ASL) in accordance with art. 1 of Italian DM 19/03/1998 ( 27/01/10 ). Resana.

INSERTION IN REGISTER OF PRIVATE CLINICAL LABORATORIES INVOLVED IN CLINICAL TRIALS

Bioanalytical part of bioequivalence/bioavailability trials and phase-I clinical trials of medicinal products by OsSC

(National Monitoring Centre on Clinical Trials of Drugs) ( 17/03/2010 ).(Resana)

Chelab Silliker - a Mérieux NutriSciences company.

Head office: Via Fratta 25, 31023 Resana, Italy. Phone. + 39 0423.7177

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AUTHORIZATION FOR USE OF INTERNATIONALLY CONTROLLED SUBSTANCES

Authorization of Italian Ministry of Health for use, only for analytical control, of substances listed in the Table I and II of the Italian DPR 309/90. Authorization nr. 14645 . Resana.

LICENCE FOR DRUG PRECURSORS

License by the Competent Authority as operator engaged in import, storage and use of substances listed in Category 1 of the Annex of Regulation (EC) No 111/2005. L icense n° 14643

. Resana.

AUTHORIZATION TO ANALYTICAL CONTROLS ON MEDICAL CHEMISTRY DEVICE

Permission of the Italian Ministry of Health to carry out chemical, physical-chemical, microbiological, technological controls on PRESIDI MEDICO CHIRURGICI ( Controls Decree PMC. No 35/2012/Off.304

). Resana.

GOOD LABORATORY PRATCTICE (GLP)

GLP CERTIFICATE

The Italian GLP monitoring authority (Italian Ministry of Health) certifies that our test facility is eligible to carry out tests in compliance with the principles of Good Laboratory Practice within the following areas of expertise: 1) Physical-Chemical

Testing; 2) Toxicity Studies; 3) Mutagenicity Studies; 4) Environmental Toxicity Studies on Aquatic or Terrestrial

Organisms; 5) Studies on Behaviour In Water, Soil and Air; Bioaccumulation; 6) Residue Studies; 9.2) Inactivation and

Removal Studies of Pathogens; 9.3) Biocompatibility Studies; 9.5) Microbiology Studies; 9.7) Pharmacokinetics/

Toxicokinetics and ADME Studies; 9.10) Biocidal/Virucidal Activity Studies ( certificate nr. 2015/8 ). Resana.

AUTHORIZATION AS FACILITY ENABLED FOR THE USE OF FISH

Authorization of the Italian Ministry of Health as facility enabled for the use of animals (fish) for experimental and other scientific purposes pursuant to the art. 12 of the Italian Legislative Decree 116/92 ( Decree Nr. 298/2012-A 21/12/2012 ) for ecotoxicological studies in fish ( Decree Nr. 94/2011-B 24/05/2011 ). Resana.

APPROVED LABORATORY COMPETENT TO CARRY OUT THE TEST REQUIRED BY THE REGULATION (EC)

648/2004

Registered in the list of approved laboratories that are competent to carry put the tests required by the Regulation (EC)

648/2004, according to Article 8(2) of Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31

March 2004 on detergents

. Resana. List approved .

CONSUMER GOODS

ACKNOWLEDGMENT TO PERFORM ANALYSIS ACCORDING TO ECOLABEL UE SYSTEM

Approval by the Ecolabel- Ecoaudit Committee to perform the independent preliminary control (according to regulation

66/2010) necessary to obtain the European mark for ecological quality ECOLABEL. Resana lab. Certificate Ecolabel .

The approval covers the following products:

- Hand dishwashing detergents (Decision 2011/382/UE);

- Detergents for dishwashers (Decision 2011/263/UE);

- Laundry detergents (Decision 2011/264/UE);

- All purpose detergents and cleaners for sanitary elements (Decision 2011/383/UE)

AUTHORIZATION BY VINCOTTE

Authorization for analysis of packaging necessary to obtain the mark OK COMPOST in according to standard EN

13432:2000 and directive 94/62/EEC. Resana lab. Authorization Vincotte .

REGISTRATION CPSC

Registration in the Consumer Product Safety Commission (CPSC) list as qualified laboratory lead testing on paint, children’s metal jewelry, children’s metal products and children’s non-metal products. Resana lab.

Registration CPSC .

REGISTERED AS ICEA QUALIFIED LABORATORY

Registered as ICEA qualified laboratories (Ethical and Environmental Certification Institute) for certification of cosmetics.

Resana lab. Registration ICEA .

Chelab Silliker - a Mérieux NutriSciences company.

Head office: Via Fratta 25, 31023 Resana, Italy. Phone. + 39 0423.7177

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ENVIRONMENTAL - INDUSTRIAL

ACKNOWLEDGMENT FOR ANALYSIS ON EMISSIONS, DUMPS, GARBAGE AND REUSABLE MATERIALS

Acknowledgment of Veneto Region for physical, chemical and biological analysis on emissions, dumps, garbage and reusable materials according to L.R. nr. 33/85 and its subsequent changes and amendments. Resana lab.

ACKNOWLEDGMENT OF COMPLIANCE FOR ANALYSIS ON ASBESTOS

Acknowledgment of compliance of Italian Health Ministry for analysis on asbestos according to D.M. of 14/05/1996 by

MOCF, SEM and DRX. Resana lab.

QUALIFIED SUPPLIER FOR ENI S.P.A.

Registration in the Vendor List of Eni S.p.A. for the execution of chemical, physical and product analysis. Resana lab and

Priolo Gargano.

ARPAV QUALIFICATION

Qualification for analysis on soil in accordance with DGRV 2241/05 e DGRV 1407/06 . Resana lab.

REGISTRATION IN THE LIST OF THE LABORATORIES AUTHORIZED TO CONDUCT FERTILIZERS ANALYSIS according to D.M. n. 3235 24/02/2014of Italian Agriculture Ministry. First registration: decree 27/04/2011. Resana lab.

Registration in the list of the laboratories authorized .

Chelab Silliker - a Mérieux NutriSciences company.

Head office: Via Fratta 25, 31023 Resana, Italy. Phone. + 39 0423.7177

Rev 86 020715 – P. 5 / 5 www.merieuxnutrisciences.it

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