- Internal control of the production process is the process of fulfilling the responsibilities set out in the second, third and fourth paragraphs, by which the producer ensures, on his own initiative, that his EU fertilization product complies with technical regulations and officially declares this compliance.
- The manufacturer creates a technical file 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) 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 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.
e) Product test reports - 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 previously specified technical dossier content and the relevant conditions of the technical legislation.
- 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 should be available upon request from the relevant authorities. - The obligations of the manufacturer specified under the fourth article can 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.