a) a comprehensive description of the EU fertilization product and a description of its intended use corresponding to its declared function,
b) EU fertilization product concept design, a list of component materials used, information on manufacturing processes,
c) Declaration of conformity of the EU fertilization product,
d) Drawings, diagrams and explanations necessary to understand the manufacturing, storage and recovery process of the EU fertilization product,
d) Sample of a label or brochure or both containing the required information
e) In the case of partially applied harmonized standards or common specifications, technical documents shall include the applied sections,
f) technical and administrative evidence showing that the EU fertilization product complies with the application procedures or adopted national measures, if it contains by-products;
g) If the EU fertilizer product contains derived products, the commercial documents or health certificates required under the legislation in question and documents proving that the derived products have reached the final point in the production chain within the scope of this legislation,
h) the results of the calculations and examinations carried out,
I) Product test reports
i) Hazardous waste calculations for EU fertilizer products containing certain substances
a) The manufacturer applies to a notified body of his choice to evaluate the quality system he applies for his products. The application must contain the following information:
a-1) The name and address of the manufacturer, and in case the application is made by the authorized representative, also the name and address of the authorized representative.
a-2) Written statement stating that the same application has not been made to another approved organization,
a-3) All relevant information for the planned EU fertilization product category,
a-4) Documentation regarding the quality system.
a-5) The technical file specified in the second article.
b) The quality system ensures that the products comply with the relevant rules of the technical legislation. All elements, rules and provisions adopted by the manufacturer are maintained by filing in the form of written policies, procedures and instructions in a systematic and orderly manner. Quality system documentation; It is organized in a way that allows quality programs, plans, manuals and records to be interpreted consistently. The quality system documentation includes sufficient information and explanations, in particular:
b-1) Management's quality objectives and organizational structure, as well as its responsibilities and authorities regarding product quality.
b-2) Relevant production, quality control and quality assurance techniques, processes and systematic actions to be taken.
b-3) Inspections and tests to be carried out before, during and after production and the frequency of their performance.
b-4) Quality records such as inspection reports, test and calibration data, qualification reports of the relevant personnel.
b-5) Tools for the supervision of ensuring the desired product quality and the effective operation of the quality system.
c) The notified body evaluates the quality system to determine whether it meets the conditions specified in paragraph (b). The notified body assumes that the elements of the quality system in accordance with the relevant rules of the national standard implementing a relevant harmonized standard and/or technical specification comply with the requirements specified in point (b). In addition to experience in quality management systems, at least one member of the auditing group must have evaluation experience in the relevant product field and product technology and knowledge of the relevant rules of technical legislation. The audit also includes an assessment visit to the manufacturer's workplace. The inspection team reviews the technical file referred to in the second article in order to verify the manufacturer's ability to diagnose the relevant rules of the technical legislation and to carry out the necessary inspections to ensure that its product complies with these rules. The notified body notifies the manufacturer of its decision. The notification also includes the results of the audit and justified evaluations of the decision.
d) The manufacturer undertakes to fulfill its obligations arising from the quality system as approved and to maintain the quality system in a way that remains adequate and effective.
d) The manufacturer informs the notified body that approved the quality system about any changes it intends to make in the quality system. The notified body evaluates the proposed changes and decides whether the changed quality system meets the conditions specified in paragraph (b) or whether a re-evaluation is required. The notified body notifies the manufacturer of its decision. The notification also includes the results of the audit and justified evaluations of the decision.
a) The purpose of surveillance is to ensure that the manufacturer fully fulfills its obligations arising from the approved quality system.
b) The manufacturer allows the notified body to enter the production facilities, inspection and testing laboratories and warehouses in order to make an evaluation, and provides the notified body with all necessary information and documents, especially the following:
a-1) Documentation regarding the quality system.
a-2) The technical file referred to in the second article.
a-3) Quality records such as inspection reports, test and calibration data, qualification reports of the relevant personnel.
b) The notified body carries out periodic inspections to ensure that the manufacturer maintains and implements the quality system and issues an inspection report to the manufacturer.
c) The notified body may additionally make visits to the manufacturer without notice. During these visits, the notified body may, if necessary, conduct or have product tests performed to confirm that the quality system is functioning correctly. The notified body issues a visit report to the manufacturer and a test report if testing has been carried out.
a) The manufacturer shall place the CE marking and the identification number of the notified body specified in Article 5 on each individual packaging of each EU fertilizer product that meets the requirements of the relevant technical legislation, or, if supplied without packaging, in a document submitted together with the EU fertilizer product.
b) The manufacturer must issue a written EU declaration of conformity for an EU fertilizer product or type and keep it, together with the technical documentation, for submission to national authorities for 5 years after the EU fertilizer product has been placed on the market. The EU declaration of conformity must identify the EU fertilizer product or type for which it is issued.
c) A copy of the EU declaration of conformity must be available upon request from the relevant authorities.
a) Documents specified in paragraph (a) of the fifth paragraph.
b) The changes specified in paragraph (d) of the fifth paragraph, in their approved form,
c) Notified body decisions and reports specified in subparagraph (d) of the fifth paragraph and subparagraphs (c) and (d) of the sixth paragraph.
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1. EU type examination is a conformity assessment process in which the technical design of the EU fertilization product is examined and it is verified and approved that this design complies with the relevant rules of technical legislation.
2. EU type examination may be carried out following one of these methods:
a) Analysis of a sample (production type) representing the finished product in the production process.
b) Determination of the suitability of the product design and evaluation of a sample of at least one of the important components of the planned product (combination of production and design types), by review of the technical dossier of the product and the additional evidence specified.
c) Determining the suitability of the product design by evaluating only the technical file and additional documents without the need to examine the design type (sample) sample.
Internal audit of the production process and testing of the EU fertilization product under supervision indicates that the manufacturer has fully fulfilled the duties and responsibilities listed in the second, third, fourth and fifth paragraphs, ensured under its own initiative that the product complies with the standards required by the technical regulations, and officially declares this conformity. It is a conformity assessment procedure declared by.
The manufacturer creates a technical dossier containing the necessary risk analyzes and assessments to determine that the EU fertilization product complies with the relevant legislation. This file is directly related to the conformity assessment of the product and details the design, manufacturing process and functionality of the product. In each case, the technical file contains at least the following information:
a) a comprehensive description of the EU fertilization product and a description of its intended use corresponding to its declared function,
b) EU fertilization product concept design, a list of component materials used, information on manufacturing processes,
c) Declaration of conformity of the EU fertilization product,
d) Drawings, diagrams and explanations necessary to understand the manufacturing process of the EU fertilization product,
d) A sample label or brochure containing the required information,
e) In the case of partially applied harmonized standards or common specifications, technical documents apply sections,
f) technical and administrative evidence showing that the EU fertilization product complies with the application procedures or adopted national measures, if it contains by-products;
g) results of calculations made, examinations carried out, etc.
h) test reports, including reports on product checks for oil retention and explosion resistance,
I) Documents showing that the EU fertilization product complies with the adopted national measures, as well as technical and administrative evidence showing that they comply with the criteria established by the authorized actions,
i) Names and addresses of the sites and site operators where the EU fertilization product and its main components are produced
The manufacturer carries out all necessary measures throughout the production process and the supervision of this process in order to guarantee compliance of the produced EU fertilization product with the content of the previously mentioned technical dossier and the relevant requirements of the technical legislation.
One or more elements of each manufactured product are subjected to one or more tests by the manufacturer or by a different organization on its behalf in order to verify its compliance with the relevant rules of the technical legislation. These tests are carried out by an in-house accredited unit or under the responsibility of a notified body determined by the manufacturer, at the choice of the manufacturer. In cases where the tests are carried out by a notified body, the manufacturer puts the identity registration number of this organization on the product during the production stage, under the responsibility of this organization.
The manufacturer follows these steps:
The manufacturer shall affix the CE marking on each individual packaging of each EU fertilizer product that meets the requirements of the relevant technical legislation or, if supplied unpackaged, in a document accompanying the EU fertilizer product.
The manufacturer issues a written EU declaration of conformity for an EU fertilizer product or type and makes it available to national authorities together with technical documentation for 5 years after the EU fertilizer product is placed on the market.
c) A copy of the EU declaration of conformity must be available upon request from the relevant authorities.
The manufacturer's obligations specified under Article 4 may be fulfilled by its authorized representative. For this purpose, the authorized representative must be specified in the authorization document, acting on behalf and under the responsibility of the manufacturer.
