The market operator must develop and maintain documentation, in particular regarding specifications, production formulas, and process sheets, which are necessary to determine the safety and compliance of finished materials or articles with the requirements established for them.
Order of the Ministry of Agrarian Policy dated October 2, 2023, No. 1743 (hereinafter referred to as the Order) establishes mandatory requirements for the written declaration of conformity of materials and articles intended to come into contact with food products, as well as the list of documents confirming the information in the declaration. The enactment of the Order is associated with the entry into force of the Law of Ukraine «On Materials and Articles Intended to Come into Contact with Food Products».
The order establishes the mandatory minimum of information and documents for the declaration of conformity of materials and articles intended to come into contact with food products.
The order covers a wide range of materials and articles, namely: active materials and articles, intelligent materials and articles, adhesives, ceramics, cork, rubber, glass, ion-exchange resins, metals and alloys, paper and board, plastics, printing inks, regenerated cellulose, silicones, textiles, varnishes and coatings, waxes, wood.
The general rule is that materials and articles at all stages of distribution must be accompanied by a written declaration of conformity, except at points of sale to final consumers, taking into account the following specific features:
regarding active and intelligent materials and articles is specified the requirement also applies to their components and/or substances, regardless of whether they come into contact with food products or with components intended for the production of such materials and articles, or with substances intended for the production of such components;
- ceramic articles intended to come into contact with food that have not yet been in contact with food must be accompanied by a declaration of compliance at all stages of distribution, including points of sale to end consumers;
- Varnishes and coatings manufactured using 2,2-bis(4-hydroxyphenyl)propane (bisphenol A (BPA)) must be accompanied by a declaration of conformity at all stages of production and distribution, except for points of sale to final consumers.
The order also details the mandatory requisites of the declaration described in Section II of the Order: identification of the market operator, description of the material/subject, regulatory basis of conformity, data on conducted tests, information on restrictions of use, expiration date, etc.
The Order also establishes the market operator’s obligation to develop and maintain the relevant documentation in paper and/or electronic form, as described in detail in Section III of the Order.
Thus, the market operator is obliged to develop and maintain documentation:
1) regarding the specifications, manufacturing formulas, and process charts required to determine the safety and compliance of finished materials or articles with the requirements established for them;
2) in which information is recorded about:
– carrying out production processes related to ensuring the safety and compliance of finished materials or items with the requirements established for them;
– results of the quality control system functioning.
Regarding active and intelligent materials and articles, plastic materials and articles, ceramic articles, as well as varnishes and coatings intended to come into contact with food, the market operator must have additional documents containing information on:
1) rules and conditions for conducting laboratory research (testing) to verify compliance with established migration limits, as well as their results;
2) the name and address of the laboratory that conducted the respective tests (assays);
3) evidence regarding the safety of materials and articles or a justification demonstrating their compliance with legal requirements.
What is also important, the Order allows materials produced before entry into force shall remain in circulation until the expiration of their shelf life.
Therefore, in accordance with the Law of Ukraine «On Materials and Articles Intended to Come into Contact with Foodstuffs», the Order details the requirements for declarations of conformity and the technical documentation that confirms the information specified in the declaration.
