of July 17, 2014 No. 594
About approval of Sanitary regulations about proper production practice for groups of the materials and products intended for contact with foodstuff
Based on part (1) and parts (9) article 9 of the Law No. 78-XV of March 18, 2004 on foodstuff (The official monitor of the Republic of Moldova, 2004, No. 83 - 87, the Art. 431), with subsequent changes and amendments, article 6 of the Law No. 10-XVI of February 3, 2009 on the state supervision of public health (The official monitor of the Republic of Moldova, 2009, No. 67, the Art. 183), with subsequent changes and amendments, and parts (2) article 3 of the Law No. 113 of May 18, 2012 on establishment of the general principles and instructions of the legislation on safety of foodstuff (The official monitor of the Republic of Moldova, 2012, Art. No. 143-148, 467), with subsequent changes, and also for the purpose of ensuring high level of protection of public health DECIDES: the Government
1. Approve Sanitary regulations about proper production practice for the materials and products intended for contact with foodstuff it (is applied).
2. The sanitary regulations about proper production practice for the materials and products intended for contact with foodstuff become effective in 6 months after its publication in the Official monitor of the Republic of Moldova.
3. To impose control over the implementation of this resolution on the Ministry of Health, work and social protection.
Prime Minister |
Iurie Leanca |
Countersigns: Minister of Health |
Andrey Usaty |
Approved by the Order of the Government of the Republic of Moldova of July 17, 2014, No. 594
The sanitary regulations about proper production practice for the materials and products intended for contact with foodstuff (further – Regulations), shift provisions of Regulations (EU) No. 2023/2006 of the Commission of December 22, 2006 about proper production practice for the materials and products intended for contact with foodstuff (the text is related to the EEA) (JOL 384, on December 29, 2006, p. 75-78), and No. 1935/2004, Items is specific measure in sense of Regulations (EU) and), c) d), e), f), g), h), i) parts (1) Articles 5, which is shifted in the national legal system by the Order of the Government No. 308 of April 29, 2011. "About approval of Sanitary regulations on the materials and products intended for contact with foodstuff".
1. These Regulations establish requirements about proper production practice for groups of the materials and products intended for contact with foodstuff (further - materials and products), listed in appendix No. 1 to the Sanitary regulations on the materials and products intended for contact with foodstuff approved by the Order of the Government No. 308 of April 29, 2011.
2. These Regulations are applied in all sectors and at all production phases, conversions of materials and products, except for sectors on production of initial substances as primary raw materials.
3. Requirements of these Regulations are obligatory for producers of the materials and products intended for contact with foodstuff, the control and regulating bodies (The national agency of public health).
4. The specific regulations stated in Items 7-8 of these Regulations are applied to the specified processes, as necessary.
5. In sense of these Regulations the following determinations are applied:
proper production practice – aspects of quality assurance which guarantee that materials and products are made and controlled in consecutive procedure for ensuring compliance to the applied regulations and the quality standards, according to their proper use so that not to threaten human health or not to cause inadmissible changes in structure of foodstuff or deterioration in their organoleptic indicators;
system of providing with quality – set of the held organizational and documentary events accepted for the purpose of ensuring with materials and products of proper quality according to the regulations and the quality standards necessary for their application and purpose;
quality control system – systematic application of the measures taken in system of quality assurance providing compliance of raw materials, intermediate and final materials and products to the specifications provided in system of quality assurance;
part which does not contact with foodstuff – the surface of material or product which is not in direct contact with foodstuff;
part which contacts with foodstuff – the surface of material or product which is in direct contact with foodstuff.
6. Economic operators shall guarantee that production operations were performed by means of:
1) effective and documentary system of quality assurance. The corresponding system considers professional training and competences of personnel in production of materials and products, including general and specific sanitary provisions in the field of production of the materials and products intended for contact with foodstuff and also the organization of technology production processes, providing thus compliance of ready materials and products to the applied regulations;
2) selections of raw materials according to production specifications for ensuring compliance of material or product to the applied regulations;
3) development and maintenance of the corresponding documentation on paper and in electronic format about specifications of parameters, formulas of production and processing, the different carried-out production operations which are relevant for compliance and safety of ready material or product, and also results of quality control system;
4) realization and maintenance of effective quality control system at development stages of specifications of production, control of compliance to health requirements of raw materials and finished goods on safety indicators, according to specifications, the technical manufacturing documentation, the organization of laboratory control of indicators of safety in the presence of contracts with accredited laboratories in the area, in the absence of own laboratories;
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