2333024440 65 Kyprou & I. Petridis, Alexandria info@physiologike.gr



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Certification Regulation

ΔΜ 3-15 | Γ' ΕΣΥΔ |

1. Subject of the Certification Regulation

The Certification Regulation briefly describes the procedures implemented by PHYSIOLOGIKI within the framework of the control and certification system, as well as the rights and obligations of the contracting entrepreneurs in accordance with Regulation 848/2018 and the relevant National Legislation.

2. PHYSIOLOGIKI IKE

2.1 PHYSIOLOGIKI as a Legal Entity

PHYSIOLOGIKI is a limited liability company that operates as an approved control and certification body for organic agriculture and livestock products. Its headquarters are located in Alexandria, Imathia.

2.2 Operating Principles

  • Respect for the Natural Environment
    PHYSIOLOGIKI adopts the basic principles of the movement for organic agriculture and ecology, with the aim of protecting the environment.
  • Quality of Services Provided
    The company controls and certifies businesses and their products based on organic production specifications, in accordance with Regulation (EC) 848/2018.
  • Responsibility and Sense of Responsibility
    PHYSIOLOGIKI carries out the work of control and certification responsibly, ensuring the interests of entrepreneurs and consumers.
  • Objectivity and Impartiality
    The company ensures the independence and impartiality of its actions, keeping its staff free from any dependence that could influence their judgment.
  • Free Access to Services
    PHYSIOLOGIKI provides free access to its services to any business operating in the field of organic agriculture, regardless of size or location.

2.3 Objectives of PHYSIOLOGIKI

The protection of the environment and ecosystems, by enhancing biodiversity.

The promotion of organic agriculture and sustainable development.

The continuous training and updating of its human resources.

The improvement of its services with the aim of developing the organic agriculture sector.

2.4 Organic Production Specifications

PHYSIOLOGIKI applies Regulation (EC) 848/2018 and its applicable amendments regarding the minimum requirements.

2.5 Changes to Organic Production Specifications

PHYSIOLOGIKI monitors developments in legislation and adapts its system and operation according to new data, while constantly informing its staff.

 

3. Inclusion Procedure

3.1 Application and Solemn Declaration

The entrepreneur can submit his application and the data declaration to the company secretariat, in order to start the inclusion process.

3.2 Signing of the Contract

The entrepreneur signs the Control Contract and the Financial Agreement, within one month of submitting the application and verifying the data through an on-site inspection.

3.3 Additional Control Contract

If the entrepreneur wishes to include new areas or populations, he signs an Additional Control Contract.

3.4 Start of the Conversion Period

The conversion period begins with the notification of the farmer's activity to the competent authority, in accordance with article 34 of Reg. 848/2018.

 

4. Certification Decision and Imposition of Sanctions

4.1 Certification Decision

The certification decision is taken by the Certification Officer after verifying the compliance of the enterprise during the surveillance.

4.2 Granting of Certification

Depending on the type of enterprise, the corresponding certificates and attestations are granted after the on-site inspection.

4.3 Revocation of Certification

PHYSIOLOGIKI reserves the right to revoke the certificate in case of non-compliance or termination of the contractual relationship.

4.4 Suspension of Certification

PHYSIOLOGIKI may suspend the validity of the certificate in cases required by the regulations.

4.5 Refusal to Issue Certificates

PHYSIOLOGIKI may refuse to issue a certificate if the entrepreneur does not fulfill his financial obligations.

4.6 Regulatory Changes

PHYSIOLOGIKI informs the contracting parties of regulatory changes and supervises their implementation.

4.7 Grading of Non-Compliances

Non-compliances with the organic production specifications are divided into three categories:

A. Minor

These non-compliances concern non-compliance with the requirements of EU and national legislation on organic farming in matters of minor importance. They do not affect the integrity of organic or in-conversion products and do not lead to the imposition of sanctions on operators. The precautionary measures are proportionate and appropriate, while the controls applied by the operator are effective. If affected products are identified, the traceability system can identify them in the supply chain and prohibit their placing on the market with a reference to organic production. The causes of the non-compliance are remedied when the operator takes appropriate corrective actions, which must be accepted within strict time limits. The repetition of the same non-compliance within 3 years is considered a recurrence.

B. Major

Non-conformities in this category concern the operator’s failure to take appropriate precautionary measures and the insufficient effectiveness of controls. In this case, the traceability system can identify the affected products in the supply chain and prohibit their placing on the market with a reference to organic production. These non-conformities affect the integrity of the organic or in-conversion product. They also occur when the minor non-conformity is not corrected in a timely manner by the operator. In this case, the reference to organic production in the labelling and advertising for the affected batch or production cycle is prohibited. The operator must implement a new conversion period, limit the scope of its certificate and improve the operator’s precautionary measures and controls.

C. Critical

Critical non-conformities are consistent with the operator’s failure to take appropriate precautionary measures and with the insufficient efficiency of controls. In addition, the traceability system does not provide sufficient information to identify the affected products in the supply chain and it is not possible to prohibit the placing of products on the market with a reference to organic production. These non-conformities seriously affect the integrity of the organic or in-conversion product. They also occur when a major non-conformity is not corrected in a timely manner. In these cases, a new conversion period is required, a ban on placing the products on the market for a specific period and a restriction on the scope of the certificate.

If there is a recurrence, the company may face the suspension or withdrawal of the certificate for 1-3 years, with simultaneous termination of the contract with the certification body and a ban on concluding a new contract.

 

4.8 Supervisory Board

PHYSIOLOGIKI assigns the supervision of the audit-certification work to a collective body, the Supervisory Board, which consists of representatives of entities with a direct interest in Organic Agriculture (suppliers, consumers, traders, etc.). The members of the Supervisory Board must not have a personal interest in their participation in it.

The purpose of the Board is to supervise the reliability and social benefit of the work of PHYSIOLOGIKI. It examines the financial, operational and quality course of the entity and may intervene in the formulation of its policy. In exceptional cases, the Board may reformulate decisions that it considers inappropriate or disproportionate and impose appropriate measures.

In case of non-compliance of PHYSIOLOGIKI with the decisions of the Board, the Supervisory Board has the right to report the incident to the competent authorities.

5. Certificates and Labels

5.1 Product Certificate

The entrepreneur or producer group that has received certification may request and receive a Product Certificate for the marketing of organic products.

5.2 The Certification Document

The official Certification Document certifies compliance with Reg. 848/2018 and is issued electronically through the TRACES application, if the controls allow it. In exceptional cases, handwritten certificates are issued.

5.3 Rules for the Use of Certificates

Entrepreneurs collaborating with PHYSIOLOGIKI must:

Use the Certificate only for information and not for the marketing of products.

Do not use it in a manner that causes confusion or misleads the public.

Immediately comply with the penalties of suspension or revocation of their certificate.

5.4 Identification Mark

PHYSIOLOGIKI grants the Identification Mark to the entrepreneur or group of producers, which is accompanied by the company code and can be used on certified products.

5.5 Rules for the Use of Marks

Entrepreneurs must:

Use the marks with caution, avoiding any misleading of the public.

Notify PHYSIOLOGIKI of the planned labeling and advertising material 20 days before their release.

6. Control - Surveillance

6.1 Surveillance Procedure
Approval Officer:
General Manager
Editor: Quality Manager
Issue/Approval: 03/02/2023
CERTIFICATION REGULATION DM 3-15 3rd ESYD Page 10

By integrating the entrepreneur or group of producers into the control-certification system of PHYSIOLOGIKI, the company undertakes surveillance with the aim of:

  • The smooth compliance with the organic farming standards
  • The implementation of measures for the entrepreneur's transition to the fully organic stage
  • The immediate identification of deviations, irregularities and violations and the taking of necessary measures
  • The correct use of Certificates and Labels

Surveillance is implemented through:

  • Full and Extraordinary Control
  • Sampling for laboratory analyses

 

6.1 Regular Audit
The regular audit is carried out at least once a year and includes:

  • Audit of facilities
  • Accounting audit
  • Audit of compliance with the required documentation
  • Audit of compliance with the Organic Farming standards, in accordance with Reg. 848/2018

For the enterprises referred to in article 34 par. 2 and article 35 par. 8 of Reg. 848/2018, an annual inspection may not be carried out, provided that no non-compliances have been identified in the last three years. In this case, the time interval between two audits shall not exceed 24 months.

For producer groups: at least 5% of the members shall be subject to an annual audit.

6.2 Extraordinary Inspections
Extraordinary inspections are carried out on at least 10% of the contracted operators annually. (See DEP 2 - Inspection Procedure).

6.3 Unannounced Inspection Visits
PHYSIOLOGIKI carries out unannounced inspection visits on at least 10% of the regular and extraordinary inspections, without warning.

6.4 Sampling and Analyses
PHYSIOLOGIKI takes samples (water, soil, agricultural products, plant or animal tissues) from at least 5% of the operators and 2% of the members of each producer group. The samples are sent to the contracted laboratory for analysis. The results are communicated to the operator and the counter-sample is kept for at least 30 days.

 

7. The Right to Object and Appeal

7.1 Objections
The entrepreneur or producer group has the right to file an objection against:

  • A Decision to Impose a Sanction by the Head of the Control Department
  • Any other act or omission of PHYSIOLOGIKI

The objection must be submitted within 5 working days of receipt of the decision. The objection is always submitted in writing, either through a special form or with any written request.

7.2 Appeals
The entrepreneur has the right to file an appeal against:

  • Decisions on the objection by the Quality Manager
  • Decisions concerning the control and certification process

The appeal must be submitted within 5 working days of notification of the decision. The appeal must be in writing, and can be made through a special form or other written submission.

 

8. Financial Terms of Cooperation with PHYSIOLOGIKI

8.1 Entity Income
PHYSIOLOGIKI derives its income only from fees for audit and certification services.

8.2 Pricing Policy
PHYSIOLOGIKI issues detailed price lists per sector of activity.

8.3 Financial Agreement
The financial agreement is signed simultaneously with the Audit Contract and analyzes the financial terms.

8.4 Settlement of Financial Obligations
In case of non-payment of financial obligations by the entrepreneur, PHYSIOLOGIKI may terminate the contract after two notices.

8.5 Services from PHYSIOLOGIKI
PHYSIOLOGIKI provides comprehensive inspection and certification services, including extraordinary inspections, issuance of certificates, and coverage of analysis costs. The entrepreneur assumes the cost of additional procedures or analyses.

 

9. Termination of the Partnership with PHYSIOLOGIKI

9.1 Ways to Terminate the Partnership

The cooperation may end with:

  • Expiry of the agreed duration of the Audit Contract
  • Complaint by the entrepreneur, with compensation to Physiologiki
  • Referral of the entrepreneur to the Supervisory Authority due to breach of obligations

 

10. Confidentiality

PHYSIOLOGIKI is fully committed and assumes responsibility for the protection of confidential information concerning contracted entrepreneurs. The company implements a specific policy for the protection of the personal data of its partners.

The communication or disclosure of information to third parties is carried out only with the express consent of the entrepreneurs. However, PHYSIOLOGIKI reserves the right to provide information to the Supervisory and Supervisory Authorities, in the context of their cooperation with the O.E.&P. In this case, provided that there is no legal prohibition, PHYSIOLOGIKI is obliged to inform the contractor of the communication.

Approval Officer: General Manager
Editor: Quality Manager
Issue/Approval: 03/02/2023
CERTIFICATION REGULATION DM 3-15 C` ESYD Page. 16

Information concerning the contracting party and originating from other sources is also treated as confidential.

 

11. Rights and Obligations of the Entrepreneur

All collaborators with PHYSIOLOGIKI sign statements, undertaking to adhere to the principle of confidentiality.

11.1 Liabilities

The Contracting Entrepreneur has the following obligations:

  • To keep a personal file with the data of YA 2543/103240/2017 and article 39 par. 1 of Regulation (EC) 848/2018 for at least five (5) years, and to provide them, whenever required, to the competent bodies.
  • To comply with the specifications for Organic Agriculture and Livestock in accordance with applicable legislation.
  • To be informed and follow the amendments to the control-certification system by PHYSIOLOGIKI.
  • To accept the controls and cooperate with the controllers of PHYSIOLOGIKI, "ELGO-DIMITRA" and the EU control bodies, providing free access to premises and records.
  • To allow the controllers to take samples for analysis, in order to verify compliance with the requirements for organic production.
  • To keep accounting books and required documents in accordance with the provisions of Regulation (EC) 848/2018.
  • To provide certificates from the Certification Bodies of its partners.
  • To comply with the rules for the use of Certificates and Marks, to notify product labeling and promotional materials to PHYSIOLOGIKI before their release on the market.
  • To record and respond to complaints and denunciations for certified products in the Complaints Book.
  • To comply with the sanctions and corrective measures imposed on it by PHYSIOLOGIKI.
  • To comply with financial obligations and to immediately inform PHYSIOLOGIKI of any changes that may affect the certification process.
  • To maintain a record of consumer complaints regarding the certification and to take the necessary corrective measures.
  • Correct non-conformities and inform PHYSIOLOGY in a timely manner.

 

11.2 Rights

The Contracting Entrepreneur has the following rights:

  • To be informed of the results of inspections and sampling.
  • To sign inspection reports and record observations.
  • To submit complaints or objections regarding the procedure or decisions of PHYSIOLOGIKI.
  • To be informed of the information concerning him and communicated to the Supervisory Authority.
  • To terminate the cooperation with PHYSIOLOGIKI, after settling his financial obligations.


 


 

Approval Officer: General Manager
Editor: Quality Manager
Issue/Approval: 03/02/2023
CERTIFICATION REGULATION DM 3-15 C` ESYD Page 18