Revision dated 3 2013-10-10 Page 1 of 23 BRC - TœV Italia

Revision dated 3 2013-10-10

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GENERAL REGULATIONS FOR CERTIFICATION

Description of the revision

Misprints and clarifications

Department Date Name Signature

Preparation : PS-FHB 2013-10-10 Marco Berruti F.to Marco Berruti

Verification : RQ 2013-10-10 Luca Boniardi F.to Luca Boniardi

Approval : PS-FHB 2013-10-10 Nicola Berruti F.to Nicola Berruti

TÜV Italia - TÜV SÜD Group

INDEX 1. Introduction .............................................................................................................................. 3

2 Objective and Legal Validity ..................................................................................................... 3

1. Area of Application and Reference Documentation .................................................................. 3

3.1 BRC Global Standard for Food Safety .............................................................................. 4

3.2 BRC Global Standard for Packaging and Packaging Materials ......................................... 4

4. Terminology and Definitions ..................................................................................................... 5

5. Liability ..................................................................................................................................... 5

6. Supervision of rules and Regulations ................................................................................... 5

7. Certification procedure ............................................................................................................. 5

7.1. Pre-Audit .............................................................................................................................. 6

7.2. Start of the Certification Procedure ....................................................................................... 7

7.2.1 Definition of the Scope of the Audit ................................................................................. 8

7.2.2 Determination of the Audit Team ........................................................................................ 8

7.4. First Certification Audit ......................................................................................................... 9

7.5 . Audit Progression ................................................................................................................ 9

7.6 Handling of the results of the Audit ...................................................................................... 10

7.6.1 Classification of requirements and scoring .................................................................... 11

7.6.2 Developement of an “Action Plan” and approval of corrective actions ........................... 11

7.7 Emission of the certificate .................................................................................................... 13

7.8 Renewal Audit ..................................................................................................................... 14

7.8.1 Scheduling re-audit dates.............................................................................................. 14

7.8.2 Justifiable circusmstances for a delayed re-audit .......................................................... 15

7.8.3 Justifiable circusmstances for an anticipated re-audit .................................................... 15

7.9. Revisit Audit ....................................................................................................................... 15

7.10 Extension Audits ................................................................................................................ 15

7.11. Follow up Audits ............................................................................................................... 15

7.12. Unannounced audit sheme (only BRC Global Standard for Food Safety) ......................... 16

7.13. Audit of Multiple Sites ....................................................................................................... 17

8. Index of companies with a certification ...................................................................................... 18

9. Procedures to refer to the certification ....................................................................................... 18

9.2 BRC Global Standard Directory ........................................................................................... 19

10. Suspension /Withdrawal of the Certificate ............................................................................... 19

11. Handling of complaints and notifications from client companies and other interested parties .. 20

12. Supervision of the examination report by TÜV Italia SRL ........................................................ 20

13. Modification of the certified productions .................................................................................. 20

14. Modification of the rules of the certification sytem ................................................................... 20

15. Specifications regarding Companies that have gained their Cerification from other entities .... 21


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16. Privacy Protection ................................................................................................................... 21

17. Litigation, Complaints or Appeals ............................................................................................ 21

18. Complaints regarding TÜV ITALIA .......................................................................................... 21

19. Pay scale Table for BRC Certification ..................................................................................... 22

19.1 Annual BRC registration Fee ............................................................................................. 22

20. Billing ...................................................................................................................................... 22

20.1 Billing in case of cooperation between TÜV Italia and TÜV SÜD Management Service GmbH 22


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1. Introduction

TÜV Italia S.r.l. (denoted TÜV Italia in the following text) is an organization for certification which works according to the guidelines of the norms UNI CEI EN ISO/IEC 17065:2012 concerning the certification of products and according to UNI CEI ISO/IEC 17021:2011. TÜV Italia has adapted its activities to a quality system. It takes into consideration the current valid jurisdiction and subjects itself to a voluntary regulation and has developed this certification scheme in order to give clients the confidence to work in the field of certification with professionalism, expertise and transparency. TÜV Italia does not perform consulting, either in the sector of product certification or regarding the management system of pertaining documents; that means it aims at guaranteeing the utmost correctness and transparency concerning the certification process in accordance with this regulations. TÜV Italia is a self-supporting entity that finances itself from the payments for the subsequent main activities: certification of management systems (quality, environment, occupational health and safety , IT-security, social responsibility etc.); examination and certification of products; training; examination and environmental certifications; examination and safety certification.

2 Objective and Legal Validity

This regulation defines preconditions and procedures for certification according to BRC Global Standards:

BRC Global Standard – Food

BRC Packaging Global Standard – Food Packaging and Other Packaging Materials

This document aims to define and co-ordinate the certification activities which pertain to the BRC schemes, as well as to the relationship between TÜV Italia and a company. This regulation came into effect on the date of the publication and replaces the previous regulation regarding BRC certification. This document is in force from the date of publication and replaces any previous version of it. The Organization has a month to adapt to the new rules or to terminate the contract.

1. Area of Application and Reference Documentation

This regulation must be applied uniformly and impartially with regard to all companies which choose to use the certification services of TÜV Italia concerning the applicable scheme. There are no fixed rules regarding financial arrangements and other owned conditions in particular. Access to the certification is not dependent on the size of the company, or membership in a particular association or group, and is also not dependent on a number of companies that are already certified. This does not touch the applicability of other regulations connected with other certification schemes under which the company may already be certified by TÜV Italia and/or other certification entities. BRC certification activity is conducted by TÜV Italia using the accreditation ACCREDIA. You may directly view the certificate and all relevant attachments comprising the areas covered by the accreditation on the sites www.tuv.it and www.accredia.it . The norms (or comparable documents), which are applicable with BRC Certification are:

• Requirements for Certification Bodies Offering Certification Against The Criteria of BRC Global Standards, (rev.applicabile)

• BRC Global Standard for Food Safety - Issue 6 July 2011

• BRC Global Standard for Packaging and Packaging Materials - Issue 4 February 2011

• Other reference documents for BRC Certification are:


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• UNI CEI EN ISO/IEC 17065:2012 - General Regulations for Entities which manage certification systems for Products

• IAF GD5:2006 - Guidance on the Application of ISO/IEC Guide 65:1996

• UNI CEI 70017:2008 (ISO/IEC Guide 67:2004) – Conformity Evaluation – Main Elements of product certification

• ACCREDIA RG-01 - Regulation fpor Accreditation of certification entities

• ACCREDIA RG-09 - Regulation for using the Trade mark ACCREDIA

• ACCREDIA RT-06 - Regulation for accreditation of certification entities in the sector of products/services certification;

• ACCREDIA Products in contact with food (MOCA) – Regulation for accreditation in the sector of materials in contact with food "MOCA" [2010-03-23]

Other reference documents for IFS Certification are: IAF GD5:2006 - Guidance on the Application of ISO/IEC Guide 65:1996; UNI CEI 70017:2008 (ISO/IEC Guide 67:2004) – conformity evaluation – main elements of product certification; ACCREDIA RG-01 - Regulation for accreditation of certification entities; ACCREDIA RG-09 - Regulation for using the Trade Mark ACCREDIA; ACCREDIA RT-06 – Regulation for accreditation of certification entities in the sector of products/services certification; Regarding everything that has not been explicitly predetermined by this regulation please refer to the current valid version of the applicable standard and to the official explanations and interpretations of the proprietor of the Standard (i.e.: FAQ guidance notes, position statements).

3.1 BRC Global Standard for Food Safety

The certification scheme BRC Global Standard for Food Safety is applicable to the production of processed food and to the preparation of primary products supplied as retailer branded products, branded food products and food or ingredients for use by food service companies, catering companies and food manufacturers. The certification will only apply to products that have been manufactured or prepared at the site where the audit has taken place and will include storage facilities that are under the direct control of the production-site management. The Standard shall not apply to food products which do not undergo any process at the site audited or to activities relating to wholesale, import, distribution or storage (outside the direct control of the company in certification process) The BRC has developed a range of Global Standards setting out the requirements for the wide range of activities undertaken in the production, packaging, storage and distribution of food. Appendix 1 provides further detail of the scopes of, and relationship between, the current Global Standards.

3.2 BRC Global Standard for Packaging and Packaging Materials

The certification scheme BRC Global Standard for Packaging and other Packaging Materials is applicable to the production of packaging materials to be used in direct contact with food but also to the materials used as primary packaging in sectors other that the food industry, i. e. consumer products as well as packaging materials for storage and distribution for all types of usage.

This can be applied to:

- Production and retail of packaging material used for the packaging of food and for bottling


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- Production and retail of other non-processed or transformed material used in packaging or for following packaging operation (i.e. inks, coatings, adehesive)

- disposable consumer products to be used in contact with food (i.e. plastic plates, papercups and disposable cutlery);

- Packaging materials for cosmetics, personal hygiene products and baby care products.

The Standard shall apply to products which undergo the production process at the site audited and includes storage under the direct control of the company in certification process

4. Terminology and Definitions

The wording of the Regulation is compliant to following norms:

- UNI EN ISO 9000:2005 "Quality management systems – Fundamentals and vocabulary";

- UNI CEI EN 45020 (February 2006): "Standardization and related activities – general vocabulary";

- BRC Global Standard for Food Safety

- BRC Global Standard for Packaging and Packaging Materials

5. Liability

The Product Manager Food (subsequently called PM) is liable for the editing, the update and the enforcement of this regulation. Any modification of this regulation can only come into effect after approval by the PM.

6. Supervision of rules and Regulations

This documenti s available to all interested parties on the website: www.tuv.it However companies may request a copy on paper. TÜV Italia properly informs all companies which have a certification contract in the case of a revision of the regulation. Every modification is highlighted by a vertical line adjacent to the modified text. In case of new editions, as the changes are significant, single modifications are not highlighted on the contrary the entire content of the document will prevail.

7. Certification procedure

To obtain a BRC Certification, a company needs to demonstrate that it comply to the requirements of the reference standard. This is a certification of products from the agricultural-groceries and non agricultural-groceries sector. Therefore the elements listed in table 1 below are necessary in order to comply with reference document UNI CEI 70017:2008 for certifications of product type 6. BRC Certification procedure in detail includes following phases:

• Starting the certification process • Planning of the audits for the first certification; • on-site visit for certification (includes document check regarding quality management and

HACCP System); • development and issuance of the preparatory report and of an action plan to be drawn up

(list of highlighted points of the audit) from the company • the company develops an Action Plan with detailed corrective measures, date of

implementation and the name of the person in charge at the company; • transmission of the action plan to the auditor; • The Auditor approves the action plan (following possible clarifications) and drafts a final

report; • evaluation from approval committee of TÜV Italia; • Issuing of the certificate after positive evaluation by the approval committee of TÜV Italia ;


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• Periodical audits for maintaining the certificate (renewal audit), which may include follow-up audits in order to ascertain whether corrective measures – as required by the renewal audit – have been carried out.

Table 1

Element of the System of Product Certification

(Ref. ISO/IEC Guide 67:2004 Table 1) Paragraph of RG-IFS Regulation

Determination of characteristics by means of inspection and evaluation of the production processes

7.4 First Audit of the Certification

Evaluation of the reports regarding the examination 7.6 Handling of audit results

Decision regarding Certification 7.7 Issuing of the Certificate

Licensing for using the Trade Mark 9 Reference modalities of the Certification

Monitoring of production processes and/or of the applicable elements of the quality system which are connected to the products in certification

7.8 renewal Audit (re-audit)

7.9 additional Audit (re-visit)

7.11 surveillance audits

7.12 unannounced audits

All BRC Certifications are specific to the product and the site.

This means that the certificate will refer in detail to the production site where the whole processing of the products takes place. In case the product processing takes place in different sites of the company, the certificate may list the producting subsidiaries,

I.e.: One certificate pertains to 2 subsidiaries in case one is responsible for dairy production, the other for aging the product, produced in the first site; whether the product cannot be sold if not processed (aged), or in general, if the first site produces unprocessed product, which will be completed in the second site. In the case of one certificate pertaining more interdependent subsidiaries every site shall be audited. Each independent site which produces end products needs to obtain it´s own certificate. The area of application of each audit is agreed upon by the company and TÜV Italia and is also highlighted in the audit report and on the certificate. Regarding the certification of companies with many subsidiaries please see paragraph 6.12 of this regulation.

7.1. Pre-Audit

This concerns a visit which is done under request of the client. It takes place before the actual certification process starts. The modalities for the conduction of Pre-Audits are subject each time, to prior agreement with the client; it might mean a site visit, or a preliminary necessary document check either at TÜV Italia, or at the company, or both. The pre-audit allows TÜV Italia a deeper understanding of:

• the dimensions and the kind of activity of the company; • the suitability check to establish if the company can deal with the certification process; • The production process of the products to be certified � possible applicability of norms and legal requirements;


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• The required expertise of the assessors for the certification prior to the first visit on-site; • The entirety of the necessary resources for the transaction of the first visit for the

certification.

� The type of experience required of the auditor team to under take the first audit for the certification

� Resources necessary to undertake the first on site audit for the certification

An on-site pre-assessment will allow the company to:

� clearly identify the scope and of the audit and its extension; � identify eventual deficiencies in the documentation prepared for the certification process; � identify eventual deficiencies in the performance of the Standard requirements and of the

certification regualtions � Obtain clarifications on details of the certification process � A more accurate estimation of the duration of the certification process and refine the related

schedule

TÜV Italia only undertakes optional on site pre-assessment before the certification process begins officially. Such action is not considered part of the certification process and its optional exevution does not reduce the audit time due for the certification.

The results of the first visit are concisely recorded by the audit team in the adequate form. The report only determines where the requirements of the norm are not met without mentioning which actions have to done to achieve the conformity to the requirements. In order to ensure that an independent judgment by TÜV Italia is granted to the company during the certification process, the auditors performing the Pre-Audit procedure, shall not be the same as the ones performing the certification audit.

TÜV Italia performs the pre-assessment visit before the official start of the certification procedure. This is not part of the certification process and this optional on-site pre-assessment does not reduce the audit duration for the certification

7.2. Start of the Certification Procedure

TÜV Italia sends the applicant the informative questionnaire to collect the necessary items of Information to formulate an offer. By means of the data provided from the applicant, TÜV Italia determines whether the application can be accepted or not and proposes an objective for the certificate to the applicant and determines the duration of the audit according to the rules defined from the Standard. (see Section III, Part 1, paragraph 7.3 of the Standard BRC Food) To assess the expected time required to undertake the audit on the production site, the calculation table, developed from BRC, will be used (for further information please visit www.brcglobalstandards.com). In the event that the audit against the Standard BRC, should be combined with other Standards, the total audit time shall be sufficient to fulfill the BRC protocols and it shall be calculated by multiplying the estimated required time for the BRC Audit by a conversion factor between 1,1 and 1,5. The details of the combined audits shall be specified on the audit report After accepting the commercial quote and with it, the General Regulations for Certification, by signing the offer, TÜV Italia shall issue an Order Acknowledgement that finalises the contractual relationship between the parts. In the event that some inconsistencies emerge during the evaluation of the documents or during the certification audit, against what has been previously declared from the company in the questionnaire, the commercial quote may be subject to review by TÜV Italia


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The contract between the company and TÜV Italia for Certification against BRC is valid for 3 years. During this time, the first audit for certification and at least 2 following audits are undertaken according to the modalities explainded in the following paragraphs.

7.2.1 Definition of the Scope of the Audit

The scope of the audit, products produced and manufacturing processes, shall be agreed between the Company and TÜV Italia in advance of the audit is performed in order to ensure the allocation of an auditor with the correct category and product knowledge The audit scope shall be examined against an attentive risk analysis and validated, before the beginning of the audit, and eventually modified. The objective of the audit is clarified without any ambiguity in the contract and thus verbalized in the audit report as well as on the certificate. It includes the entire activity of the company and not only the production line concerning the products using the TM of the distributors. At the beginning of the audit and afterwards, an attentive risk analysis is taking place, the objective of the audit is revised and evaluated and if necessary modified. The exclusion of products from the audit objective of BRC Food shall be only acceptable in the case that the excluded products can be clearly differentiated from products within scope and make up a minority of the products produced at the site; in the case that the products are produced in a separate area of the factory; or in the case that they are produced on different production equipment. Where exclusions from audit objectives are allowed these shall be clearly stated on the audit report and certificate issued and these will be related only to the products processed at the audited site Products purchased for resale as factored goods by the company cannot be included within the scope of the certificate. Two Product categories are identified within the Standard BRC Packaging on the base of the hygienic risk connected to the end usage of the packaging materials

• High Risk: high hygiene risk for the packaging intended for direct contact with food or with other high hygiene-sensitive products.

• Low risk: low hygiene risk for packaging intended for consumer products and storage and distribution.

The permitted exclusions from audit scope for the Standard BRC Packaging shall be allowed only in the case that these scopes cannot be applied to the production of specific materials. Such exclusions shall be clearly defined on the audit report

7.2.2 Determination of the Audit Team

TÜV Italia employs only auditors who possess a BRC qualification for BRC audits and whose profile matches the product scopes and technology scopes, and is in accordance with the activity of the company that is audited (see appendix 3 and 4 in the BRC Standard to check the requie specific skills, the auditor must have to under take a BRC audit).

TÜV Italia retains for at least 5 years the detailed record of the auditors´ training

In case of a conflict of Interest the company may not accept an auditor proposed from TÜV Italia

TÜV Italia shall avoid permitting the same auditor to audit more that three times in sequence the same site (5 times in the case of BRC Packaging)

7.3. Planning of the Audit

All types of Audits are undertaken in compliance to the norm UNI EN ISO 19011

Each audit is planned.


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The audit due dates and the auditor team are to be notified to the company in written form, furthermore, the team leader of the audit needs to develop an audit plan, which will is sent to the company at least 2 days in advance. 1 The company reserves the right to request information regarding the audit team assigned by TÜV Italia and to receive it. In case of a conflict of interests, the company has the right to object to the team members. According to the norms which supervise certification activities, the company must allow observers of TÜV Italia or of the accreditation entity and/or of BRC, who are appointed with the monitoring of auditors, to take part in the audit. The company has the right to not accept this, to object to the monitoring of the audit, but this leads to the non-concession of the certificate or a suspension/ withdrawal of the certificate. During the audit planning it shall be duly taken into account that the Auditor team must have the opportunity possibility to assess the company verifying all requisites expected from the Standard, all production processes in the same site and all products within the certification scope.

7.4. First Certification Audit

The first certification audit aims to assess whether the company possesses effective means to manage processes and products, object of the certification in order to guarantee compliance with the specific requirements of the chosen BRC Standard, of the general regulations for certification and its related documentation. The audit regards the activities, mentioned in the certification scope, including products and processes that the company wants to certify, which are assessed according to the applicable requirements of the BRC standard. The audit includes documental review and verification of the production process at the company premises: the Company guarantees that the production program, i. e. the activity during the audit will be as representative as possible for all products/ services which are included in the scope of the certification. In the case of sporadic / seasonal production, the audit may last several non consecutive days and is only considered finished when all products/ product groups, included in the certificate objectives have been audited. If a company possesses different subsidiaries, which execute the same processes for the same products, every subsidiary shall be specifically audited. Every site gets its own certificate depending on the audit result. If a company has decentralized structures for production and one audit at one site is not enough to gain a complete overview of the qualitative characteristics of the company, all other production sites need to be taken in consideration in the audit. All relevant sections of the BRC Standard are be regarded as applicable from the company; the eventual non-applicability of some requirements is to be justified by the company with a risk analysis and will be assessed by TÜV Italia during the audit.

7.5 . Audit Progression

Every audit starts with an opening meeting with the participation of the head of department of the company and the audit team. Main aims of this meeting are the:

• Introduction of the attendees and confirmation of the respective functions;

• Confirmation of the scopes and areas of application of the audit;

• Confirmation of the audit duration and and necessary resources to undertake the on site assessment

• Provide a brief account of the audit procedures

1 See par 7.12. for unannounced audit


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• Confirmation of communication channels;

• Offering clarifications regarding the certification process to the company; • Confirmation of the possibility of necessary protective equipment (DPI) for the audit team; • Providing information to the company regarding the methods of reporting and classification

of the highlighted points; • Providing information regarding the complaint procedure for the audit handling and/or the

results of the audit. • Confirmation of Privacy Protection regarding the information that the audit team receives

During the audit, the team collects evidence via document check, direct observation of the activities, and interviews with the persons in charge and with the operative personnel. The audit team uses a check list that has been prepared in advance and has to be considered as a guideline, and not as binding document. (The team may carry out researches which are not explicitly part of the check list). TÜV Italia undertakes sample audits, in order to get the assurance that the ongoing processes, regarding the certified product, are effectively contributing to the achievement of the compliance – and in the case of a detected non compliance, the company shall carry out corrective actions. However these assessments do not exclude the presence of non-conformities, (and also of non conformities, which have not been noticed at all) against the binding requirements, hence the maintenance and evaluation of compliance to the binding requirements remains under the sole responsibility of the company If the evaluation group from TÜV Italia detects non compliance with one or more binding requirements, which not directly relate to the objective of the audit, the management board shall be notified as well as the approval committee of TÜV Italia which decides about the issue of the certificate and after consulting with the committee for safeguarding impartiality (CSI). During the audit, the company will fully assist the audit team in all phases of the audit, but especially in these cases:

• The company allows the audit team to access all areas which are relevant to assess the processes to be certified and allows the staff to be interviewed;

• The company provides detailed information, in compliance to the legal requirements on hygiene health and Safety at work, regarding specific risks they may face during the assessment and informs them about preventive and emergency measures. Furtehermore the company will provide the audit team with (IPD) individual protective equipment, or informs TÜV Italia prior to the proceedings about the kind of IPD required for the audit team to assess the company

• The company provides the audit team with the documents for the performance of the audit (manuals, procedures, instructions, programmes etc.) as well as with the records required by the norm against which the company wishes to be certified.

• The company appoints a person as “interface point” with TÜV Italia for the time during all phases of the certification procedure.

In case the company has an External consultant, this may attend the proceedings upon request of the client during the inspection, but does not replace any other person in charge in their function.

7.6 Handling of the results of the Audit

The audit concludes with a closing meeting, during which the audit team presents a summary of the audit findings to the management board; the company receives a pre-report regarding the evaluation including list of audit results (whether positive as well as non conformities) and the level of certification achieved, which is appointed according to the non conformities identified.


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The report contains brief but full information regarding the company services in every area of the standard and provides the necessary elements to evaluate an improvement over time. (through the following reports of the renewal audits). If it is not possible to release to the company a pre-report and the list of audit results during the closing meeting, these will be sent to the company from the Lead Auditor within 2 working days after the closing of the assessment. The final report will be released together with the certificate. As determined by the ISO/IEC Guide 65, the certified company must inform the chosen certification body within 3 working days about any relevant events regarding the products which did not comply to the requirements of the certification system, such as alerts, product recalls or complaints.

7.6.1 Classification of requirements and scoring

The BRC classifies non conformities in three different levels:

Critical: where the requirement is not met due to legal issues or critical issues for the safety of the product

Major: where there is a substatial failure to meet the requirement “statment of intent” or any clause of the Standard or a situation is identified which would, on the basis of available objective evidence, raise significant doubt as to the conformity of the product being supplied. Minor: where a requirement has not been fully met but, on the basis of objective evidence, the conformity of the product is not in doubt. It is therefore not allowed to award a single major non-conformity where minor non-conformities are repeatedly raised against a particular requirement. In case that more than 20 minor NC are awarded but no major NC, the auditor must provide a written explanation in the audit report All evidence and NC will be communicated to the company at the time of the findings and will be discussed further during the closing meeting. Even in case of a Critical NC or a Major NC the audit will be brought to the end in order to offer the company a correct assessment of all requirements

7.6.2 Developement of an “Action Plan” and approval of corrective actions

For each non-conformity raised, the company shall, in addition to undertaking the necessary immediate corrective action, undertake a review of the underlying cause (root cause) of the non-conformity. The root cause shall be identified and an action plan to correct this, arranged. The terms for the submittal of correction of the NC and the verification process from the side of TÜV Italia are reported in the following tables. In case the company fails to submit evidences of the close out of the evidenced NC, TÜV Italia shall raise a critical NC to the company and the certificate will not be issued The action plan shall be verified and approved by the auditor and enclosed in the final report, it does not influence the grade awarded but it may influence the final decision to grant a certification or not


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Table 2- BRC Food

Grade

Critical or major nonconformity against the statement of intent of a fundamental

requirement

Critical Non-

conformities

NC Major

NC Minor

Corrective actions

Procedure to verify

corrective actions

Audit freque

ncy

A/A+

1 to 10 28 days Documentary 12

months

B/B+

11 to 20 28 days Documentary 12

months

B/B+

1 1 to 10 28 days Documentary 12

months

C/C+

21 to 30 28 days Inspection 6

months

C/C+

1 11 to 30 28 days Inspection 6

months

C/C+

2 1 to 10 28 days Inspection 6

months

No grade

1 or more

Certification not granted

Re-audit

No grade

1 or more


Re-audit

No grade

31 or more


Re-audit

No grade

2

21 or more


Re-audit

No grade

3 or more


Re-audit


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Table 3- BRC Packaging

Grade

Critical or major nonconformity against the statement of intent of a fundamental requirement

Critical Non-

conformities

NC Major NC

Minor Corrective

actions

Procedure to verify

corrective actions

Audit frequen

cy

A 10 or less

28 days Documentary 12

months

B 1 10 or less


months

B 11 to 20


months

C 2 0 to 20 28 days Inspection 6

months

C Less than

2 to 30 28 days Inspection

6 months

D 1 or more Certification not granted

Re-audit

D 1 or

more

Certification not granted Re-audit

D 3 or more Certification not granted

Re-audit

D 2 21 or more

Certification not granted Re-audit

D Less than

2 31 or more


Re-audit

7.7 Emission of the certificate

The procedure described in the previous paragraph is followed in each audit conducted by TÜV Italia at the certified companies, whether it concerns the first audit or the renewal audit. The task of the approval committee (CDA) is to decide about the certification of the company and about a check of the report of the audit team and other data which regard the practice. During the examination of the audit report CDA may decide to request clarifications from the audit team or about a new additional investigation with a new on site assessment. Every different evaluation of the CDA – against those of the audit team – will be communicated to the company in due time. Following the positive feedback from the approval and within 42 days from the first audit date, TÜV Italia issues a conformity certificate according to the described scopes of the company. The report shall be uploaded on the BRC directory within 7 working days from the certificate emission date. The certificate shall be issued only after the commercial quote for the audit and the reporting requirement has been accepted by the company and the due amount received by the certification body. (Including the BRC annual fee). The validity of the certificate is 6/12 months (depending on the grade awarded, as per previous Table) + 42 days, starting from the first day of the certification/renewal audit )


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The emission of the certificate automatically means the permission for the company to use the certificate and the released BRC TM according the predetermined modalities of the standard. The documents proving the certification are:

a) a letter of certification, containing: the positive decision, the conditions for maintenance of the certification, the deadline for the following renewal audit, information regarding how to use of the BRC logo;

b) A certificate, containing: ID-No. with corresponding revision date, if certificate shall be revised, trade name with subsidiaries and addresses, reference requisites, area of application in IT and EN including eventual exclusions from certification, the product category, emission date - the same as the decision date for the certification-, the logo of the accreditation body, a deadline for subsequent audits, the signature of the head of the department.

Validity depends on the technical and economic conditions which are presented in this regulation. If the approval committee decides against a certification, a new application for certification may be submitted at the earliest after 6 months from the decision date.

7.8 Renewal Audit

Renewal audits aim at guaranteeing that certified companies possess an effective system to ensure compliance to the requirements of the applicable BRC standard. The first audits for certification and the annual renewal audits are conducted in the same way and evaluate the requirements against the standard. At the beginning of the renewal audit, the company documentation is examined again, particularly the section revised by the company from the last audit. Careful attention is placed on determining the presence of non-conformities and the examination of the fulfillment of corrective and preventive actions and their effectiveness, such corrective actions shall be specified in detail in the Action Plan of the previous audit. In case the effectiveness of an AC undertaken against an NC detected during a previous audit is evaluated negatively, as well as in case of recurrence of a NC against the same requirement, the auditor judges whether it is the case of attributing greater weight to the non conformity highlighted In the end, it will be examined whether the certificate of TÜV Italia has been used correctly, and if complaints and notifications of clients and interested parties have been handled correctly. Should the certified company not comply with the deadlines for a renewal audit, it must inform TÜV Italia in written form within, at least, 4 months prior to the assessment due date. That implies the automatic revocation of the contract with TÜV Italia and an immediate withdrawal of the certificate by TÜV Italia. If the above mentioned notification regarding a cancellation of contract reaches TÜV Italia later than 4 months prior to the nominal date of the transaction of the examination, TÜV may request the payment for the annual renewal audit as written down in the contract - even if the renewal audit was not conducted.

7.8.1 Scheduling re-audit dates

During the 3 years validity period of the certification contract, renewal audits shall be carried out at the intervals required by the certification level achieved by the company, to confirm the validity of the certificate.

The re-audits described in this paragraph correspond to the “ongoing audits” defined in the BRC Standard. The frequency of the re- audits will be 6 or 12 months (according to the abovementioned table) calculated from the first audit date, and irrespective of whether further site visits were made to verify corrective action arising from the initial audit, as well as irrespective from the certificate issue date but 28 days before the same certificate expires.


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It is the responsibility of the company to respect due dates. Where an audit is delayed beyond the due date, TÜV Italia shall raise a major non-conformity being awarded to the company at the next audit.

7.8.2 Justifiable circusmstances for a delayed re-audit

A delayed re-audit is allowed without assignation of a major NC only in following cases:

• a site situated in a specific country or an area within a specific country where there is government advice to not visit and there is no suitable local auditor

• within a statutory exclusion zone that could compromise food safety or animal welfare;

• a site in an area that has suffere a natural or unnatural disaster, rendering the site unable to produce or the auditor unable to visit.

Any circumstances that justifies a delay in the performance of a renewal audit shall be reported in the audit report.

7.8.3 Justifiable circusmstances for an anticipated re-audit

In some circumstances it is possible to undertake the audit earlier than these due dates, for example to to allow combined audits with another certification scheme, or to include a product produced at a different season. Where an audit date is brought forward the following rules shall apply:

- the audit report will detail the reasons why an audit has been brought forward.

- The re-audit due date must take in account the new audit date and reset to be 6/12 months from this

- The certificate exipry date will consider the new audit date validity 6/12 months + 42 days

7.9. Revisit Audit

If the company was graded a C level of certification at the end of the audit TÜV Italia will perform a new additional audit within 28 days from the date of the previous audit, in order to verify the closure of NC reported. Unless otherwise decided by TÜV Italy, such additional audits will be billed to the audited company

7.10 Extension Audits

If new products or procedures come into existence between 2 audits for certification, which differ from the ones mentioned in the audit objective (i.e. new production plant, new production technology, new products), the certified company notifies the certification body in a timey manner in order to obtain a risk analysis to evaluate if an extended on site audit needs to be conducted or not.

If an extension of scope is required shortly before the expiry date of the certificate it is advisable to undertake a complete new audit, followed by the emission of a new certificate which contains the same expiry date as the main certificate

The conditions for passing such an audit are the same as for a normal announced audit and non- conformities highlighted will be documented and handled according to the protocol of the standard

7.11. Follow up Audits

BRC provides the possibility, when considered necessary by TÜV Italia or by BRC (i.e. as a result of justified complaints or notifications for product recalls or lawsuits for product-safety), to perform additional audit; partial or complete, announced or unannounced.

Requests for additional visits can be filed by customers or other recipients of the audit report.

Unless otherwise appointed by TÜV Italy, these audits will be billed to the audited company


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7.12. Unannounced audit sheme (only BRC Global Standard for Food Safety)

Companies which already obtained the BRC Food certification and have been awarded a grade A, A+, B, or B+ may choose to adhere to the unannounced audit scheme. The unannounced audit options provide sites with the opportunity to demonstrate the maturity of their quality systems and successful sites are awarded grades of A+ (the top BRC grade), B+ or C+. provideing a company´s customers with added confidence in the company´s ability to consistently maintain standards.

The condition for participating to the program is to grant the auditor the possibility to access the site on his arrival. In the event that the access to the site is denied on arrival of the auditor, the opeartional costs for the assignment of the auditor and travel expenses will be billed to the company and participation to the unannounced audits scheme will be revoked. In this case, TÜV Italia has also the right to suspend or withdraw the existing certificate.

Companies that choose to participate to the unannounced audit programme, must apply to TÜV Italy (at least three months after the last audit).

There are two options for the unannounced audit programme. With both options the date of the audit of the factory good manufacturing processes (GMPs) is unannounced

Option 1: For option 1, the whole Standard is audited on a single unannounced audit visit, typically lasting two days.

When choosing to participate in the programme the company has the right to communicate periods (up to 15 days) in which it shall not be possible to perform unannounced audits. In the case of seasonal production the production period must be notified when presenting the participation request to the program. During this period, no date can be made unavailable for an assessment audit.

The duration of the non announced audit is the same as the duration o fan announced one and will be performed between the 3rd and 12th month counting from the date of the previous audit (typically between the 8th and 12th month).

The date of the audit shall not be communicated in any way to the company.

The audit will commence within 30 minutes from the arrival of the auditor on site and after a brief opening meeting it will begin with a visit to the production site and, if the production is in progress, with the verification of the manufacturing processes.

At the end of the audit, if the company has obtained a grade of A + or B +, the company shall choose:

- Confirm its participation in the program with Option 1;

- Confirm its participation in the program but switch to option 2;

- Waive participation to the programme.

In case of awarded grade C + the participation to the unannounced audit programme shall be revoked automatically.

Option 2, the audit visit is split into two separate visits, each typically lasting one day. The first visit, which is unannounced, assesses predominantly factory GMPs, as highlighted by the colour-coding system in the Standard requirements. The second part of the audit, which is planned, assesses predominantly the documented systems and records. This approach allows companies to ensure that appropriate managers are available to assist with the audit of documentation.

When choosing to participate to the program the company has the right to communicate periods (up to 10 days) in which unannounced audits shall not be performed


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The total duration of the audit is the same as the duration of an announced one and is equally divided into two parts.

The first part of the audit (unannounced) will be held between the 6th and 10th month from the previous audit and it begins, after a brief opening meeting, with a visit to the production site and, if the production is progress, with the verification of the manufacturing processes. The auditor verifies the GMP requirements (see colored partitions of the requirements in the standard), but can also check records supporting the evidence related to these requirements.

The auditor records in the check list the audited evidences and at the end of the visit, issues the list of NC detected (and gives it to the company). The company prepares an Action Plan to correct the detected NC and to define the AC to eliminate the root causes and sends it to TÜV Italia for approval within 28 days from the end of the visit. The actual implementation and effectiveness of the AP will be verified during the second part of the audit. In case the result of the first part of the audit indicates a grade that does not allow the renewal of the certificate (see abovementioned table), the existing certificate is immediately withdrawn, otherwise the existing certificate remains valid until a new certificate is issued at the end of the second part of the audit.

The second part of the audit (agreed with the company) will be made within 28 days before the expiry of the 12 months from the last audit and has as its object the verification of documents and records, but must include a visit to production site in order to verify the AC relating to any NC detected in the first part of the audit.

The auditor records the audited evidences in the check list and during the closing meeting, confirms the NC detected and gives the list to the company. The company prepares an Action Plan to correct the detected NC and define the AC measures to eliminate the root causes and sends it to TÜV Italy, for approval in accordance with the deadlines in the table above. The actual implementation and effectiveness of the AP will be verified according to the procedures and schedule in the table above and depending on the level of certification achieved.

The audit report is issued at the end of the second part of the audit and also shows the evidence and any NC relating to the first part of the audit.

All NCs highlighted during both phases audit contribute to the calculation of the level of certification achieved by the company.

If the final result of the audit awards a grade that does not allow the renewal of the certificate (see table above), the existing one is immediately withdrawn.

if the company obtains a grade of A + or B + at the end of the audit, they may choose:

- Confirm participation to the program with Option 2

- Confirm participation to the program but switch to option 1

- Waive participation to the program

In case the grade C + is awarded, the participation in the program is automatically terminated.

In case of seasonal production the production period must be notified when adehering to the program. During this period, no date can be made unavailable for audit.

If the company decides to choose option 2 of the programme, in order to allow the completion of corrective actions, the audit of documents and systems will take place on a fixed date at least 28 days before the expected start of the seasonal production.

7.13. Audit of Multiple Sites

The BRC certificate shall be only site specific (related to only one production site). However more than one site may be included under a single certification in case all of the following rules apply:

• all sites are under the same organisation ownership


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• all sites are operated against the same documented quality management systems

• sites manufacture product which is part of the same manufacturing process

• the sites solely supply the other sites with no additional customers

• the sites are no more than 30 miles/50 km apart

All sites must be visited as part of the same audit schedule (i.e. within same timeframe).and the audit report as well as the certificate must clearly state that the audit the audit has consisted of visits to more than one site address.

In order to audit all activities within a manufacturing group and all requirements against the standard for companies with a production site separated from the central office, the assessment will be conducted following these indications:

• during the audit the company will provide all ietms of information and documents required to verify the requirements managed in the central office of the comapny

• a two stage at both the sites will be performed (i.e. Head office location and manufacturing site). In this case the transfer time from one site to another shall not be part of the audit duration and must be specified in the audit plan.

For futher details on the management of these two kinds of audit please refer to appendix no. 7 in the BRC Food Global Standard

8. Index of companies with a certification

TÜV Italia updates monthly the list of certified companies. The following information is published: � trade name of certified company � certificate number � certification validity status � standard � site and subsidiaries covered by the certificate � type of products, processes, services included the certification An index of companies, certified by TÜV Italia, is available at www.tuv.it.

9. Procedures to refer to the certification

If the Certification is obtained, the company initiates – a documented procedure for the handling of reference modalities for the certification (especially for use of certificate and TM) for all communication channels. The procedure determines which function the company has, who is in charge of what and which modalities apply for the use of the certificate and the TM, to ascertain that the following preconditions are met. If the BRC Certification is obtained, the company may use it during the period of validity in publications of technical and public nature, in correspondence etc. and respecting procedures defined by the applicable BRC Standard. The correct usage of the certificate and the correctness of the references to the certification in general are examined by the audit team during the renewal audit and are recorded under in the report. Where appropriate the audit team issues a NC in this subject. An incorrect use of the certificate may lead to the withdrawal/revoke of the same In case of suspension or withdrawal of the certificate the company must cease using the certificate and any other reference to the certification TÜV Italia reserves the right to take legal actions, should this not happen


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Partial copies of the certificate are not allowed, augmentation and reduction are allowed without distortion of the certificate structure. But they have to be uniform and legible.

9.1 Using the BRC logo

The BRC Logo is protected by Copyright and is a registered TM, absolute property of the British Retail Consortium. Using the BRC Logo is only allowed under formal authorization in compliance to the conditions explained under section III paragraph 13 in the BRC Standard and on the Website www.brcdirectory.com. Using the BRC Logo and referring to the BRC Certification is not allowed on the packaging of final products or on the packaging for the final consumer.

9.2 BRC Global Standard Directory

TÜV Italia shall inform the company that the certification data are directly communicated from BRC

The Global Standards Directory www.brcdirectory.com is an online searchable directory of companies certificated to the BRC Global Standards for food safety, packaging, consumer products and storage and distribution. Each entry includes relevant site details, and contact and certification information. Data is centrally managed and controlled to maintain accuracy and integrity.

10. Suspension /Withdrawal of the Certificate

TÜV Italia retains the right to suspend an existing certificate for a predetermined period. There have to be grave reasons of an unassailable judgment and the company has to be notified thereof. In this case, the company loses the right to refer to the certification during this period and loses the license to use the BRC logo. Suspension and withdrawal of the certificate may happen in the following case given by te Standard and also if:

� the company refers to the certification and uses the BRC logo in a way that is not conform to the BRC rules.

� the company does not record complaints and notifications of interested parties which regard to the area covered on the certificate and the corrective measures;

� the company does not pay for the already performed services � the company does not satisfy the requirements of TÜV Italia for a conclusion of suspension; � the company modifies relevantly production processes / the management of the products in

the certification scope without informing TÜV Italia; � the company interrupts activities, or processes, or production, or supply of products and

services specified in the certificate objectives for a period of more than one year; � the company cancels the certification contract; � The company communicates that it is not interested in a renewal audit and rejects the

performance of an unannounced audit, necessary to ensure the validity of the certificate until the due date of the renewal audit.

� TÜV Italia changes the rules of the certification systems and the company does not want to adapt to the new modifications

� If the company itself formally requests the withdrawal TÜV Italia. If a certificate is suspended or withdrawn, TÜV Italia officially informs the company via registered mail with receipt and communicates the conditions to be met within a certain due date to revoke the suspension to re-issue the certificate. The suspension or the withdrawal of the certificate is also communicated to the proprietor of the standard, BRC and to the accreditation body ACCREDIA (valid for certificates that are issued within the framework of ACCREDIA´s accreditation) within 2 working days after suspension/withdrawal of the certificate and is recorded on the BRC Directory within 5 working days.


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If a company – after the suspension or the withdrawal of the certification continues to make use of it, TÜV Italia may take legal action. TÜV Italia - more precisely its approval committee - takes all decisions relating to the suspension or withdrawal of a certificate. In the case of Suspension or Withdrawal of the certificate the company must immediately inform the client. The conditions for a conclusion of Suspension or withdrawal are determined by TÜV Italia based on the reasons which led to the decision to suspend or withdraw the certificate and conform to the preconditions of the applicable BRC Standard.

11. Handling of complaints and notifications from client companies and other interested parties

The company (already certified by TÜV Italia, or not yet certified by TÜV Italia, but applying for a certification with TÜV Italia) must have a documented procedure which deals with complaints and notifications. This must assert the following:

- Record of complaints, client notifications and interested parties notifications pertaining to the activity and/or processes and/ or implementation and/or supply of products / services to be certified, which may influence the compliance with the requirements of the certification.

- Carry out an appropriate investigations regarding complaints and notifications and the recording of these;

- Implementation of corrective measures if necessary and the recording of these. The company makes these records available in case of examination from ACCREDIA representatives.

12. Supervision of the examination report by TÜV Italia SRL

By accepting this regulation the company authorizes TÜV Italia to transfer the conformity certificate (proprietor TÜV Italia) and the reports (proprietor is the audited company) to BRC where they will be enclosed in the BRC Directory and made available to third parties. The audit report and the relevant documents must be retained by TÜV Italia for 5 years. The evaluation report and the relevant documents must be retained by the company for 5 years.

13. Modification of the certified productions

Any modification which influences the compliance, safety and legality of the certified production must be notified to TÜV Italia and to the responsible place of jurisdiction promptly and in written form. The timeframe is 3 working days. TÜV Italia shall assess if an additional unplanned audit is needed due to the modifications. This may mean a revision of the certificate or the start of a new certification procedure. Not observing these conditions may lead to the suspension of the certificate. The company informs TÜV Italia promptly (or within the timeframe of 3 working days) about the presence of inconsistencies, such as law suits, accidents, emergencies and legal non-conformities. The information must relate to the occurred event and summarized in a report which describes how the event was handled and what consequences it had for the management system. TÜV Italia checks the information and the report to assess its completeness and correctness and decides what actions shall be performed:

− confirmation of certification; − possible additional audit; − suspension or withdrawal of certification.

14. Modification of the rules of the certification sytem

TÜV Italia retains the right to modify its certification system, described in this document. In this case TÜV Italia allows the certified companies to make proposals.


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If modifications are made, TÜV Italia informs about the date, at which the modification comes into effect and mentions possible corrective measures to be executed by the company. An appropriate time frame shall be granted to adapt to the modifications. If a company cannot or will not adapt the modification, TÜV Italia will withdraw/revoke the Certification.

15. Specifications regarding Companies that have gained their Cerification from other entities

A certified company, which has been certified by other bodies against a BRC Standard, can apply to TÜV Italia for a BRC Certification, under the condition that the certification with the other certification body ceases to be valid. There are no specific conditions for the transfer to TÜV Italia. The first visit will be regarded as the first audit.

16. Privacy Protection

TÜV Italia ensures that all information connected to the activity of certification is treated with absolute confidentiality, except in cases in which it is differently required by: - legal provisions; - provisions of accreditation bodies - proprietors of certification schemes. In these cases the client is advised about the information provided to third parties. The personnel at TÜV Italia connected to the certification sign a formal declaration regarding privacy protection of which the company may obtain a copy on request. Audit reports are only transmitted to companies, (a copy for the Archive at TÜV Italia) to the BRC audit team members (to upload the documents on the BRC Directory, where they will be available to third parties) and to any accreditation body, which may request a copy of them.

17. Litigation, Complaints or Appeals

The company using the certification services of TÜV Italia has the right to put in a written complaint or appeal to a decision taken by TÜV Italia regarding a suspension or withdrawal of certifications. The company that decides on such a course of action sends a registered mail with receipt to TÜV Italia s.r.l. attention head of the dept. PS-FHB – Via G. Carducci 125 – 20099 – Sesto San Giovanni (MI). This letter must bear the letterhead of the company, the subject matter of the suit, the reasons thereof, possible appendices which serve to prove the statements, the signature of the authorized representative. If one of the above listed elements is missing, the complaint will be refused. In this case TÜV Italia sends the sender a letter containing the reasons. The head of the department PS-FHB sends a confirmation of receipt of the complaint/ appeal and sends a provisional answer within 10 work days after receipt of the complaint. Simultaneously, he initiates the investigation phase of the complaint, therein including the parties involved in the process, so that the claimant will be informed about the results of the investigation. (Within 20 days from receipt of complaint) In case of a law suit against TÜV Italia srl the court having jurisdiction will be Milan.

18. Complaints regarding TÜV ITALIA

TÜV Italia takes in consideration complaints and notifications of companies (or other sources) under the following conditions:

• in writing (letter, fax, email are allowed) with detailed description of the situation causing the complaint

• name, address and residence of the complaining party must be clearly indicated • Reason for the complaint must be clear.


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If this information cannot be inferred from the notification or complaint, the company or the other source will be contacted to gain the necessary clarification. Complaints and notifications are managed by the complaint register. A letter of confirmation of the receipt is sent for every item and within 10 days from receipt of the complaint the party gets a provisional answer. Complaints are checked by the head of the department together with the quality manager and the operative and technical personnel that participated. Also, a suitable investigation is conducted. If the situation requires it, TÜV Italia retains the right to do an additional audit in order to verify the status of the management system regarding the complaint/ notification. At the end of the complaint management process, TÜV Italia sends a written notification to the protestant/ sender of the letter regarding the conclusion of the investigation and possible initiated measures. Information concerning the content of the complaint/ the notification and a solution may not be made public without the permission of the interested parties.

19. Pay scale Table for BRC Certification

TÜV Italia defines the economic conditions for the Certification so to make a suitable profit to be able to guarantee the impartiality in the performance of the certification processes and the improvement of offered services, both existing and new services.

Pay Scale Table of TÜV Italia includes the following positions: 1. Certification (audit on-site/ multi-site) 2. renewal of certificate 3. business trip expenses 4. activities connected with additional audits (i.e.: follow up audit) 5. annual fee as determined by the Standard

19.1 Annual BRC registration Fee

In order to obtain the certification against BRC the Accreditation body requires an annual fee to be paid. This does not depend on the results of the inspection. The amount will be billed by TÜV Italia in name and on the part of the proprietor of the Standard BRC. By paying the fee the certified company gives TÜV Italia permission to transmit all data regarding the Certification to the proprietor of BRC Standards and everything else necessary for a publication of the certification on the BRC Portal. TÜV Italia is not allowed to publish the final certification documents (i.e. Final report or certificate) before the payment of the annual fee has been completed.

20. Billing

Billing for the services provided by TÜV Italia takes place after the conclusion of the audit. The following terms and conditions shall apply:

− in case the company cancels the planned Audit within 20 working days prior to the Audit date already confirmed in written form, TÜV Italia retains the right to withdraw the amount for the inspection as per order confirmation;

− In case of cancellation of the certification procedure due to any reason, the company will be billed by TÜV Italia for the professional services rendered until the moment of the interruption of the certification process (in particular if the company does not start the certification procedure, after signing the contract, it will be billed for origination fees)

− TÜV Italia retains the right, to revise the contractual documents if, modifications against the conditions declared by the company (on which conditions the contract is based) are observed during the course of the certification proceedings

20.1 Billing in case of cooperation between TÜV Italia and TÜV SÜD Management Service GmbH


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In case of a co-operation between TÜV Italia and TÜV SÜD Management Service GmbH, billing takes place according to the conditions offered by TÜV SÜD Management Service GmbH.

Revision dated 3 2013-10-10 Page 1 of 23 BRC - TœV Italia

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