Pursuant to the Law of Ukraine “On Standardisation”, technical specifications are a certain normative legal document that sets up technical requirements for the products, processes, services, equipment, performance results, pre-packing, packing, labels, etc. must conform to. It also determines the procedures by which these conditions may be established or fulfilled.
This document is important when registering technical specifications for the contract manufacturing for dietary supplements, which can be obtained in the course of cooperation with Biolight, the leader in the Ukrainian market for the manufacture of food supplements. Ready-made documents for technical specifications development allow you to quickly register the product and confirm the status of the manufacturer’s intellectual property.
Technical specifications development is carried out in accordance with 2 standards:
● DSTU (State Standard of Ukraine) 1.5:2015 (ISO/IEC Directives Part 2:2011, NEQ) National standardization. Rules for technical specifications development for products, layout, and issuance of national regulatory documents.
● GOST (All-Union State Standard) 2.114-95 Unified System of Design Documentation. Technical specifications.
Technical specifications of Ukraine can be general, special, or composite. The first relates to certain similar goods, the next is focused exclusively on one material, product, or service, and the latter is focused on the constituent parts of the product.
Their availability is necessary to control all stages of the manufacturing process, they serve as a control for finished products and work performed, and become a guarantor of the protection of rights in a pre-trial and judicial proceedings.
Although this is an internal document of your manufacture:
- It will always be in the open register, and even if lost, its copy will always remain in government agencies for its speedy renewal;
- Product recognition is increased both among business partners and consumers, who will see the inscription on the product saying: “Manufactured in accordance with technical specifications...” and will be sure that the product is not a ghost and will not disappear in a month, since the permit is valid for 5 years;
- It guarantees the protection of intellectual property from unscrupulous competitors because the party whose technical specifications were registered earlier will win in judicial proceedings.
REGISTRATION OF TECHNICAL SPECIFICATIONS (DOCUMENTS FOR SELLING FOOD SUPPLEMENTS)
Although the registration of technical specifications in Ukraine was canceled in 2015, most enterprises continue registering them on a mandatory basis, relying on consulting and methodological assistance from state-owned enterprises subordinate to the Ministry of Economic Development and the Ministry of Health.
First of all new food products, flavors, proteins, enzymes, drinking mineral water, materials that are put into circulation for the first time in Ukraine, are specified in the Law of Ukraine “On Basic Requirements for Safety and Quality of Food Products”, should undergo registration of technical specifications.
To obtain permits for the production of food supplements, the following documents shall be prepared:
- Certificate of state registration of the manufacturer's enterprise.
- Application.
- A complete description of the product under the requirements of the approval of technical specifications for the products.
- The list of raw materials for the manufacture of food supplements and the sanitary and epidemiological inspection report for each component.
- Flowchart for the production.
- Instructions for use.
- Product description, packaging, labeling, and marking parameters.
- Risk monitoring under the legal framework.
- Certificates for product components.
We take on the preparation of the entire set of the documents by ourselves, only draft technical specifications and the signed and sealed constitutional documents of your company are required from you.
Our work at the stage of registration of technical specifications for food supplements is to eliminate obvious violations of the legislation and save your money before the procedure of approval and registration of technical specifications. Then the signed and certified documents are sent to Kyiv for scanning and adding to a single database. After that, we hand over the complete set of documents to you personally or by mail.
OBTAINING THE SANITARY AND EPIDEMIOLOGICAL INSPECTION REPORT
The sanitary and epidemiological inspection report has several definitions that can be found on various websites: hygienic certification under technical specifications, sanitary finding, and the State Consumer Service finding, but they do not change the essence of the document. The main purpose of the report is to obtain confirmation from government agencies that the products meet quality standards in the fields of medicine and food products, and cannot cause harm to health.
The need to obtain the inspection report is determined by more than 10 regulatory legal acts, in particular:
● the Law of Ukraine “On the List of Approval Documents in the Field of Economic Activity”;
● the Law of Ukraine “On Ensuring the Sanitary and Epidemiological Welfare of the Population”;
● the Law of Ukraine “On Waste”;
● the Law of Ukraine “On Child Nutrition”;
● the Law of Ukraine “On Pesticides and Chemicals”;
● the Law of Ukraine “On Drinking Water and Drinking Water Supply”;
● the Law of Ukraine “On the State System of Biosafety in the Development, Testing, Transportation and Use of GMOs”;
● the Law of Ukraine “On Grapes and Wine” and others.
According to this, projects of socio-economic development programs, investment programs, planning and development schemes for resorts and settlements, projects related to the living environment of people, tools and equipment, existing defense and military facilities, as well as food products, food supplements, materials, the sale of which can cause harm to health, are subject to sanitary and epidemiological expertise.
To obtain a sanitary and epidemiological inspection report, the following set of documents shall be prepared:
- Application for the execution of works for the needs of sanitary and epidemiological inspection.
- Specification (composition and indicators of the subject of examination).
- A document that declares the quality of products (composition, characteristics, shelf life, and working life).
- Data on the registration of technical specifications in Ukraine (if the product is to be imported) and a list of countries where the subject of examination is registered.
- Instructions and recommendations for use for the consumer.
- Label.
- Samples of the product for examination or documents confirming the research done in other laboratories.
- Toxicological dossier.
- Technical documentation.
Thanks to the well-coordinated system of work of the BioLight legal department, the preparation of some documents will be carried out as quickly as possible and you will be able to order technical specifications and other approvals. Then we will help in the examination of products, filling in protocols, and their further submission for signing at the Ministry of Health. After that, the sanitary and epidemiological inspection report is entered into a single register and issued directly to you.
The term for obtaining the inspection report is up to 30 calendar days; working with us, you will undoubtedly receive it in 10-14 days.
ISO 9001
The availability of an ISO certificate for food supplements is a high level of consumer confidence, which opens up equal competitive opportunities along with other brands. The certificate confirms that the product is manufactured in a safe facility and meets all standards, so the end-user can be sure that they will get a product that was manufactured in compliance with all the conditions. The international standard ISO 9001, accredited in the EU, is considered such a certificate.
The main features of the certificate are as follows:
- It is of confirmatory, not permissive nature.
- Confirms that despite external and internal changes in working conditions in production, the quality of products and services remains at a high level.
- Certification means the procedure for preparing the relevant documents for the sale of food supplements, in particular, plans, reports, methods, and enterprise activity protocols for its functioning at the highest level.
- It’s not products, but the production of any industry that undergoes certification.
- It allows taking part in tenders, builds consumer confidence, production obtains the right to receive the highest degree of accreditation.
To obtain the certificate, the constitutional documents of the company shall be prepared, as well as the staff schedule.
To speed up the process of obtaining ISO 9001, it is recommended to fill in a questionnaire regarding the activities of the enterprise, implement this standard in the company and submit documents to the national authority for examination and receipt of the document.
These are only the basic issues, as additional ones emerge during the preparation of the set of documents.
DEVELOPMENT OF HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (ISO22000)
The globalization of the food industry and increasing competition have become the basis for strengthening the food safety system both at the national and international levels, introducing ISO22000 or HACCP certification, which covers both the production of raw materials and the final consumption of the finished product.
Obtaining the certificate requires the following:
- Staff schedule, the scale of production (area).
- Description of all technological processes.
- Audit of the enterprise for the implementation of instructions according to the selected level of the quality management system.
This certificate, which you can get together with Biolight, increases the chances of participating in tenders, makes the company more competitive both nationally and internationally, and helps to minimize production costs by following the quality system of incoming raw materials.
