ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of August 11, 2015 No. 492

About approval of Sanitary regulations about the materials and products from the processed plastic intended for contact with foodstuff

List of amending documents

Based on Article 5, parts (1) and (9) article 9 of the Law on foodstuff No. 78-XV of March 18, 2004 (The official monitor of the Republic of Moldova, 2004, Art. No. 83-87, 431), with subsequent changes and amendments, article 6 of the Law on the state supervision of public health No. 10-XVI of February 3, 2009 (The official monitor of the Republic of Moldova, 2009, No. 67, the Art. 183), with subsequent changes and amendments, DECIDES: the Government

1. Approve:

Sanitary regulations about the materials and products from the processed plastic intended for contact with foodstuff according to appendix No. 1;

Additions which are made to the Sanitary regulations about proper production practice for the materials and products intended for contact with foodstuff approved by the Order of the Government of the Republic of Moldova No. 594 of July 17, 2014 according to appendix No. 2.

2. The sanitary regulations about the materials and products from the processed plastic intended for contact with foodstuff become effective after 6 months from the date of its publication in the Official monitor of the Republic of Moldova.

3. Sale and use of materials and products from the processed plastic which part the processed plastic received as a result of conversion process before entry into force of these Regulations is is allowed before the termination of inventories of these materials and products.

4. To impose control over the implementation of this Resolution on the Ministry of Health, work and social protection.

Prime Minister

Valeriu Strelets

Countersigns: Minister of Health

Ruksanda Glavan

 

Appendix №1

to the Order of the Government of the Republic of Moldova of August 11, 2015 No. 492

Sanitary regulations about the materials and products from the processed plastic intended for contact with foodstuff

The sanitary regulations about the materials and products from the processed plastic intended for contact with foodstuff (further – Regulations), shift provisions of Regulations of the Commission No. 282/2008/EC of March 27, 2008 about the materials and products from the processed plastic intended for contact with foodstuff and about modification of Regulations (EC) No. 2023/2006 and No. 1935/2004, subitems a), c), d), e), f), h), i) and j) Item is specific measure in the context of Regulations (EU) (1) Article 5, transferred to the national legal system by Sanitary regulations on the materials and products intended for contact with foodstuff, the approved Order of the Government No. 308 of April 29, 2011.

I. General provisions

1. These Regulations are applied to materials and products from plastic and to their components intended for contact with foodstuff as it is specified in Item 1 of Sanitary regulations on the materials and products from plastic intended for the contact with foodstuff approved by the Order of the Government No. 278 of April 24, 2013 which contain the processed plastic (further – materials and products from the processed plastic).

2. Action of these Regulations does not extend to the following materials and products from the processed plastic if they were made according to the regulations of proper production practice established by Sanitary regulations about proper production practice for the materials and products intended for contact with foodstuff, the approved Order of the Government No. 594 of July 17, 2014:

1) the materials and products from the processed plastic made of the monomers and raw materials received by chemical depolymerization of materials and products from plastic;

2) the materials and products from the processed plastic made from the waste formed as a result of cutting, and/or the waste received owing to production process according to the Order of the Government No. 278 of April 24, 2013 which are processed on site productions or are utilized in other place;

3) materials and products from the processed plastic in which the processed plastic is used behind functional barrier from plastic as it is specified in the Order of the Government No. 278 of April 24, 2013.

3. Action of the Order of the Government No. 278 of April 24, 2013 continues to extend to materials and products from the processed plastic to which requirements of these Regulations extend.

4. For the purposes of these Regulations the following concepts are used:

the scheme of distribution of materials in the closed and controlled chain – cycles of production and distribution in which products circulate within controlled system of reuse and distribution and in which the processed materials come only from chain elements so that inadvertent introduction of external material corresponded to engineering procedure;

raw materials from the processed food plastic – the materials and products from the processed plastic collected and uses sorted later which are used as raw materials in the course of conversion;

conversion process – process within which it is made processed plastic;

the processor – the physical person or legal entity responsible for ensuring compliance with these Regulations concerning conversion process which will be executed at the companies under its management;

the test of efficiency – demonstration of efficiency of process of conversion for exception of chemical pollution of materials or products of plastic.

II. The requirements applied to materials and products from the processed plastic

5. Materials and products from the processed plastic are placed in the market only in case they contain the processed plastic received as a result of the authorized engineering procedure of conversion according to these Regulations.

6. The engineering procedure of conversion having sanitary authorization according to Item 5 of these Regulations is controlled by means of the system of quality assurance guaranteeing that the processed plastic conforms to the requirements established by the sanitary conclusion.

This system of quality assurance shall correspond to the detailed conditions given in Items 7 and 8 of these Regulations.

7. For receipt of sanitary authorization process of conversion shall correspond to the following conditions:

1) quality of raw materials from the processed plastic shall be corresponding and be controlled according to the requirements specified in the Sanitary regulations about the materials and products from plastic intended for contact with foodstuff approved by the Order of the Government No. 278 of April 24, 2013 guaranteeing that final material or product from the processed plastic corresponds to regulations of Items 5-6 of Sanitary regulations on the materials and products intended for the contact with foodstuff approved by the Order of the Government No. 308 of April 29, 2011;

2) primary raw materials from the processed plastic shall come from materials and products from plastic which were made according to regulations of Sanitary regulations on the materials and products from plastic intended for the contact with foodstuff approved by the Order of the Government No. 278 of April 24, 2013;

3) primary raw materials from the processed plastic shall come from the products which are in the closed controlled chain that guarantees use only of those materials and products which intend for contact with foodstuff, and also exception of any pollution of primary raw materials of plastic chemicals in the concentration exceeding the regulations specified in Items 14-19 of Chapter IV of Sanitary regulations on the materials and products from plastic intended for the contact with foodstuff approved by the Order of the Government No. 278 of April 24, 2013;

4) quality of the processed plastic shall be corresponding and be controlled according to the established criteria stated in Chapters II-IV of Sanitary regulations about the materials and products from plastic intended for the contact with the foodstuff approved by the Order of the Government No. 278 of April 24, 2013, guaranteeing that final material or product from the processed plastic corresponds to regulations of Items 5 and 6 of Sanitary regulations on the materials and products intended for the contact with foodstuff approved by the Order of the Government No. 308 of April 29, 2011. The laboratory determining quality of the processed product shall be accredited according to the Law on activities for accreditation and assessment of conformity No. 235 of December 1, 2011;

5) the conditions for use of the processed plastic guaranteeing that materials or products from the processed plastic correspond to provisions of Items 5 and 6 of Sanitary regulations on the materials and products intended for the contact with foodstuff approved by the Order of the Government No. 308 of April 29, 2011 shall be established.

8. Regulations of Items 7-10 of Sanitary regulations on the materials and products from plastic intended for the contact with foodstuff approved by the Order of the Government No. 278 of April 24, 2013 are applied to the used chemicals and assessment of processes of conversion.

9. Technical documentation shall contain information provided by Items 6-8 of these Regulations for assessment of safety of process of conversion.

10. In terms, stipulated by the legislation about allowing documents of the regulating bodies (10 working days) from the date of receipt of the valid statement, the body for regulation and supervision issues the sanitary conclusion establishing compliance or discrepancy of process of conversion to the conditions provided by Items 6-8 of these Regulations.

11. Statements for issue of the sanitary conclusion, the additional information provided by applicants and the conclusions issued by body for regulation and supervision, except for to confidential information are available to the public according to the current legislation.

12. The body for regulation and supervision considers applications of applicants according to the procedure of the sanitary authorization provided in appendices No. 1 and 2 to the Order of the Government No. 384 of May 12, 2010. "About Service of the state supervision of public health".

13. The sanitary conclusion for process of conversion includes:

1) name of process of conversion;

2) name and address of the owner (owners) of the conclusion;

3) short process description of conversion;

4) the conditions or restrictions concerning primary raw materials from plastic;

5) conditions or restrictions of process of conversion;

6) the characteristic of the processed plastic;

7) the conditions concerning scope of the processed plastic which was made by means of conversion process;

8) requirements to control of compliance of process of conversion to the conditions established in the conclusion;

9) conclusion effective date.

14. The sanitary conclusion issued to the owner acts on all territory of the Republic of Moldova. The authorized process of conversion registers in the Register provided in Item 18 of these Regulations.

15. After receipt of the sanitary conclusion on process of conversion according to these Regulations the owner of the sanitary conclusion complies with all conditions or restrictions set by this conclusion.

16. The owner of the conclusion or any other economic operator applying the authorized conversion process without delay informs body for regulation and supervision on any new information of scientific or technical nature which can affect assessment of safety of process of conversion in relation to health of the person. If necessary the body for regulation and supervision reviews assessment.

17. Provision of the sanitary conclusion does not limit civil, administrative or criminal liability of economic operators in that, as for the authorized process of conversion of the materials or products containing the processed plastic made within the authorized conversion process, and foodstuff which come into contact with such materials or products.

18. The body for regulation and supervision creates and stores the Register of sanitary permissions for the authorized processes of conversion according to the Law on registers No. 71-XVI of March 22, 2007.

19. The register is available to the public by means of the official web page of body for regulation and supervision.

20. Any information entered in the Register shall include the data specified in Item 13 of these Regulations.

21. The body for regulation and supervision exercises the state control of ensuring compliance with these Regulations according to provisions of the Law on the state control of business activity No. 131 of June 8, 2012.

22. During the state control the body for regulation and supervision checks that process of conversion corresponded to the authorized process according to requirements of these Regulations and that the system of quality assurance according to Sanitary regulations about proper production practice was applied to the materials and products intended for contact with foodstuff, the approved Order of the Government No. 594 of July 17, 2014.

III. Declaration of conformity

23. In addition to requirements of Item 19 of Sanitary regulations of the materials and products intended for the contact with foodstuff approved by the Order of the Government No. 308 of April 29, 2011 and Items 31-35 of Sanitary regulations on the materials and products from plastic intended for the contact with foodstuff approved by the Order of the Government No. 278 of April 24, 2013, the declaration of conformity of materials and products from the processed plastic shall include information specified in Item 24 of these Regulations.

24. In addition to requirements of Items 31-35 of Sanitary regulations about the materials and products from plastic intended for the contact with foodstuff approved by the Order of the Government No. 278 of April 24, 2013, the declaration of conformity of the processed plastic includes:

1) information, confirmatory that only the processed plastic made as a result of the authorized conversion process with indication of the assigned number in stop on regulation and supervision for the authorized conversion process was used;

2) information, confirmatory that primary raw materials from plastic, process of conversion and the processed plastic meet specifications on which the sanitary conclusion is issued;

3) information, confirmatory that the system of quality assurance according to Items 9-10 of these Regulations is applied.

Appendix № 2

to the Order of the Government of the Republic of Moldova of August 11, 2015 No. 492

Additions which are made to the Sanitary regulations about proper production practice for the materials and products intended for contact with foodstuff approved by the Order of the Government No. 594 of July 17, 2014

The sanitary regulations about proper production practice for the materials and products intended for contact with foodstuff approved by the Order of the Government No. 594 of July 17, 2014 are supplemented with Items 9 and 10 of the following content:

"9. The system of quality assurance applied by the user shall guarantee that process of conversion conforms to the requirements established in the sanitary conclusion.

10. For all elements, requirements and provisions accepted by the user in the system of quality assurance documentation in the form of written procedures and decisions shall be kept systematically.

Documentation of system of quality assurance shall provide uniform interpretation of decisions and procedures concerning quality, for example, programs, plans, managements, records and measures in the field of quality assurance which were taken for ensuring traceability, and includes:

1) the management concerning quality assurance policy containing accurate determination of tasks of the processor in the field of quality, the organization of society including organizational structures, responsibility of managing personnel and its authoritativeness in respect of production organization of the processed plastic;

2) plans of quality control, including concerning the characteristic of primary raw materials from plastic and the processed plastic, qualification of suppliers, processes of sorting, processes of washing, processes of deep clarification, processes of heating or any other part of process important for quality assurance of the processed plastic including the choice of critical points for quality control of the processed plastic;

3) the ministerial and technological procedures applied to monitoring and management of all process of conversion including control methods and quality assurances at all production phases, especially establishment of critical limits in the Items having crucial importance for quality assurance of materials from the processed plastic;

4) methods of monitoring of effective functioning of system of quality assurance, in particular, capabilities of achievement of desirable quality of the processed plastic, including control of inappropriate products;

5) the tests and test reports applied to in time and after production of the processed plastic, the frequency of their carrying out, and also the used test equipment; traceability of calibration of the test equipment shall be provided properly;

6) the approved registration documents".

 

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