Accreditation of laboratories for food inspection
On January 10, 2019, the Cabinet of Ministers, by Resolution №10, approved the Procedure and Criteria for Authorization of Accredited Laboratories, including Reference Laboratories, and the Procedure for Verification of Compliance with Authorized Accredited Laboratories, including Reference Laboratories, Criteria for Authorization and Deprivation of Such Authorization.
The procedure and criteria determine in accordance with the Law of Ukraine "On State Control over Compliance with Legislation on Food, Feed, Animal By-Products, Animal Health and Welfare" the mechanism and criteria by which the State Consumer Service authorizes accredited laboratories, including reference laboratories (hereinafter - accredited laboratories, reference laboratories), for the purposes of state control of laboratory tests (tests) of selected samples of food, feed, hay, straw, animal by-products and any substances (including from the environment), which related to the production and / or circulation of food and feed, animal health and welfare.
The resolution contains separate criteria for the authorization of the accredited laboratory and for the authorization of the reference laboratory.
The following criteria are set for an accredited laboratory:
Authorization of an accredited laboratory is carried out according to the following criteria:
1) fulfillment of all requirements that are mandatory for accreditation by the national accreditation body of Ukraine and / or a foreign accreditation body that is a full member of ILAC - International Organization for Cooperation in the field of laboratory accreditation, in accordance with DSTU ISO / IEC 17025: 2006, ISO / IEC 17025: 2017 or other standards by which they are replaced, throughout the period from the date of obtaining the relevant accreditation;
2) the presence in the staff list of the position of the person responsible for the functioning of the quality management system;
3) appointment to the position of a person responsible for the functioning of the quality management system who has a higher education in the field of research (testing) or in the field of quality management system and experience in the relevant field for at least two years;
4) participation of an accredited laboratory in a comparative laboratory study (test) (round of professional testing) for the relevant types (areas) for which the laboratory intends to obtain authorization, which was successful and was conducted by an accredited laboratory in accordance with DSTU EN ISO / IEC 17043 : 2017 or EN ISO / IEC 17043: 2010 by the person (competent coordinator) within two years prior to the submission to the State Food and Consumer Service of the application for authorization of such laboratory or use of other methods provided by paragraph 7.7 of ISO / IEC 17025: 2017 tests);
5) availability of premises and equipment intended for conducting research (tests) in the relevant types (areas) for which the accredited laboratory intends to obtain authorization;
6) compliance with the procedure for ensuring the objectivity of research (tests);
7) observance of the procedure of accounting for research (tests), including their results, and preservation of records of such accounting for at least five years;
8) compliance with the procedure for submission by the accredited laboratory to the State Food and Consumer Service of information on:
- results of researches (tests) which testify to nonconformity (positive results), - immediately;
- changes and additions to the results of research (tests), in particular to expert opinions, protocols and other similar documents, about which the State Food and Consumer Service was informed earlier (positive and / or negative results) - immediately;
- other results of researches (tests) - not later than two working days from the day following the day of completion of laboratory researches (tests);
- changes in the activities of the accredited laboratory (extension or restriction of the scope of accreditation, temporary suspension or renewal or revocation of the accreditation certificate, change of name or location, as well as changes in activities resulting in non-compliance with the authorization criteria) - no later than ten working days their onset.
The resolution also determines the list of documents submitted by the accredited laboratory, the reference laboratory for obtaining authorization, the procedure and terms of consideration of these documents and decision-making by the State Food and Consumer Service.
Separately, this resolution also defines the procedure for verifying compliance by authorized accredited laboratories, including reference laboratories, with the criteria for authorization and deprivation of such authorization.
Such inspections are carried out by the State Food and Consumer Service. Inspections can be scheduled or unscheduled.
Scheduled inspection is carried out once every three years from the date of receipt of the authorization.
The grounds for an unscheduled inspection are:
1) submission by the authorized accredited laboratory, reference laboratory of a written application to the State Food and Consumer Service for inspection at the request of the relevant laboratory or appeal of an individual (individuals) about the violation that harmed his (their) rights, legitimate interests, life or health, the natural environment or the security of the state, with the provision of documents or copies thereof confirming such violations (if any);
2) receipt by the State Food and Consumer Service of the results of the arbitration study (test), which does not confirm the results of the main study (test) conducted by the authorized accredited laboratory, reference laboratory.
Until the completion of the unscheduled inspection, the accredited laboratory is authorized, the reference laboratory has no right to conduct research (testing) for the purposes of state control.
Grounds for depriving the laboratory of authorization:
- receipt by the State Food and Consumer Service from the authorized accredited laboratory, reference laboratory of the application for deprivation of its authorization;
- state registration of termination of a legal entity as a result of its liquidation or state registration of termination of entrepreneurial activity of a natural person - entrepreneur;
- detection of inaccurate information in the documents submitted by the authorized accredited laboratory, reference laboratory during the inspection;
- establishment of non-compliance with the authorization criteria based on the results of the inspection of the authorized accredited laboratory, reference laboratory;
- entry into force of a court decision to establish in court the fact of providing by an authorized accredited laboratory, reference laboratory unreliable results of research (testing) or conducting research (testing) in violation of the procedure established by law;
- establishing the fact of non-application by the authorized accredited laboratory for more than two years in a row of any of the methods provided for in paragraph 7.7 of ISO / IEC 17025: 2017 to ensure the reliability of research results (tests) for each of the types (areas) for which the laboratory is authorized;
- when the authorized reference laboratory has not participated for more than one year in an international comparative laboratory study (test) conducted by a non-resident of Ukraine accredited in accordance with the requirements of DSTU EN ISO / IEC 17043: 2017 or EN ISO / IEC 17043: 2010 professional testing) for the relevant types (areas), which ended with a successful result, for which the laboratory was authorized;
- restriction of the scope of accreditation, which affects the authorization, suspension or revocation of the accreditation certificate.
Lawyer's comment:
Overall, the positive signal is that the Government has finally approved such criteria and the authorization procedure for such laboratories. It is assumed that a clear procedure for accreditation of laboratories will demonopolize the market of official laboratory research in this area.
Minimum safety and health requirements in work areas
The State Labor Service has developed and submitted for public discussion a draft order of the Ministry of Social Policy, which plans to define and approve the Minimum Requirements for Safety and Health of Workers in Work Areas.
The development of this order is related to the need to implement the provisions of Council Directive Дире89 / 654 / EEC of 30.11.1989 on the minimum requirements for safety and health at work.
These Minimum Requirements establish requirements for the creation of safe and harmless working conditions through the proper arrangement of workplaces, work areas, industrial, sanitary and other premises of enterprises, institutions, organizations, regardless of ownership and activities (hereinafter - the enterprise), safe use by employees means of labor, providing training for employees and involving them in addressing issues of labor protection, regulation of relations on labor protection between enterprises in the case of involving employees of other enterprises.
The document sets out separate safety requirements for work areas used for the first time and for work areas that will already be operational by the time this order is adopted.
These minimum requirements contain mainly general provisions that are partly in line with other existing rules, such as the Fire Safety Rules.
Lawyer's comment:
We recommend to get acquainted with the project of such Minimum requirements and to develop the plan of their implementation at the enterprise. These minimum requirements will be an integral part of the general requirements for labor protection, so they must be taken into account in the activities of the enterprise.
Mandatory labeling of products with letters of the Latin and Greek alphabets has been postponed
On December 28, 2018, the order of the Ministry of Economic Development dated December 18, 2018 № 1938 came into force, which extended until January 1, 2021 the transitional period regarding the mandatory labeling of products with letters of the Latin and Greek alphabets.
These are the Rules for the Use of Units of Measure, according to which all producers of consumer products are obliged to mark the measurements of products with units of measurement of the International System of Units SI (kilograms, centimeters, liters, etc.).
Lawyer's comment:
Manufacturers now have enough time to change production processes and adapt to new labeling. We do not recommend postponing this issue until the last year, as these rules are unlikely to be postponed again.
On approval of lists of goods, export and import of which are subject to licensing, and quotas for 2019
On December 27, 2019, the Government adopted Resolution №1136, which approved the list of goods, the export and import of which are subject to licensing, and quotas for 2019.
This resolution approved the following lists:
1) volumes of quotas of goods, the export of which is subject to licensing;
2) a list of goods (ozone-depleting substances), the export and import of which are subject to licensing;
3) a list of goods that may contain ozone-depleting substances, the export and import of which are subject to licensing (except for goods transported in containers with personal belongings);
4) the list of goods, the import of which from the Republic of Macedonia is subject to licensing within the tariff quota in accordance with the provisions of the Free Trade Agreement between the Republic of Macedonia and Ukraine of January 18, 2001;
5) a list of goods, the export of which is subject to licensing.
Lawyer's comment:
These lists are approved annually. This year, the list is completely identical to the one in force in 2018, so the adoption of this act will not significantly affect the work of enterprises.
The rules for determining the origin of goods for free trade have been changed
From January 1, 2019, there are new rules for determining the origin of goods for the free trade agreement between Ukraine and the EU - Pan-Euro-Mediterranean preferential rules of origin.
In practice, the application of the provisions of the Pan-Euro-Med Convention means, for example, that a Ukrainian producer will be able to purchase raw materials or components from one of the parties to the Convention and export finished products to another duty-free or at a reduced rate.
Currently, the parties to the Convention are 25 parties: the EU, the EFTA countries (Iceland, Liechtenstein, Norway, Switzerland), Albania, Algeria, Bosnia and Herzegovina, Georgia, Egypt, Israel, Jordan, Lebanon, Kosovo, Macedonia, Morocco, Moldova, Palestine , Syria, Tunisia, Turkey, Ukraine, Faroe Islands and Montenegro.
Lawyer's comment:
Changing the rules of origin will expand the capabilities of both Ukrainian exporters and importers.
Exporters will be able to expand the range of possible suppliers of raw materials for their production. Importers will be able to save on import duties when importing a wider range of goods.
New form of inspection report of the State Construction Inspectorate
20.12.2018 The Ministry of Regional Development by its order №361 amended the order of the Ministry of Regional Development "On approval of forms of acts and other documents that are drawn up during or as a result of state architectural and construction control" from 15.05.2012 № 240.
These changes set out in new editions the form of the act on the results of the inspection of compliance with the legislation in the field of urban planning.
Lawyer's comment:
The form of the act contains the list of questions which the inspector can and will check. Therefore we recommend to the enterprises which are carrying out construction, to get acquainted with the specified act.
New wood quality standards
From January 2019, the forest industry of Ukraine moved to European standards for classification and measurement of timber and lumber. They have significantly changed the approaches to determining the size and quality characteristics of timber and lumber. If earlier business wood (round timber) in Ukraine was divided into three grades (I, II, III) and had a number of assortments for their purpose, then from 2019 - is divided into four quality classes (A, B, C, D), as and in European countries, with no definition of their direction of use.
New national standards, harmonized with European ones, were developed by the Technical Committee of Ukraine for Standardization of Forest Resources TC 18 "Forest Resources" and approved by the State Enterprise "Ukrainian Research and Training Center for Standardization, Certification and Quality".
The principle of classification according to the European system of standardization of round timber is not based on the purpose of assortments, but is based on indicators of the size and quality of logs; larger diameter and minimum content of wood defects at the established growth - the highest quality class:
- to quality class A it is accepted to carry timber of the highest quality class which in the majority come from the bottom part of a log, with pure wood or with insignificant defects which do not limit its use;
- to quality class B it is accepted to carry timber of average class of quality, without special requirements to pure wood and knots within average value for each breed;
- to quality class C it is accepted to carry timber below an average quality class in which those defects which do not considerably reduce natural properties of wood as material are allowed;
- quality class D should include timber that does not satisfy any of the quality classes A, B, C, but from which lumber can still be obtained for further use;
- all other round timber, from which it is impossible to obtain lumber for general use, are classified as:
a) firewood for industrial use, 2.0-4.0 meters long (production of wood chips for technological or fuel purposes, splitting into fuel wood, etc.);
b) wood for non-industrial use, up to 2.0 meters long (can be sold to individuals and legal entities as fuel).
The ratio between assortments of a certain purpose and variety according to GOSTs valid until 01.01.2019 and news standards can be followed by the corrective form, which can be downloaded from the website of the State Forestry Agency.
Lawyer's comment:
Changes in the classification of wood will be relevant for both sellers and buyers of such wood. Be sure to consider them when compiling the primary documentation for transactions with wood.
A draft of a new law on veterinary medicine has been developed
The State Food and Consumer Service has developed and published for public discussion a draft Law "On Amendments to Certain Legislative Acts of Ukraine Concerning Veterinary Medicine."
In addition to amendments to various regulations in the field of veterinary medicine, this bill provides for a new version of the Law of Ukraine "On Veterinary Medicine".
The bill contains many definitions of terms that were not previously enshrined in law.
The bill covers the following relations:
- ensuring animal health;
- ensuring animal welfare;
- implementation of veterinary practice;
- production and circulation of veterinary drugs, substances, medicated feeds and premixes for such feeds, as well as substances with anabolic, antimicrobial, antiparasitic, anti-inflammatory, hormonal or psychotropic properties that can be used as veterinary drugs.
The bill also defines the powers of individual bodies in the field of veterinary medicine, regulates the development, approval and review of veterinary measures, determines the list of animal diseases to be notified, establishes the responsibilities of market operators to protect animal health.
Among the responsibilities of market operators is the obligation to keep records. These operator records must contain information on:
1) species, categories, number of domestic terrestrial animals kept at their facilities, as well as identification data of these animals, if the obligation to identify them is established by the legislation on identification and registration of animals;
2) any movement of animals and aquaculture products from or to capacity;
3) veterinary documents that accompany domestic animals during import to capacity and / or removal from capacity;
4) for terrestrial domestic animals - cases of death among animals that took place at the facility;
5) for aquaculture facilities - cases of death in each epidemiological unit depending on the type of production;
6) water drainage (for facilities where slaughter or processing of aquaculture facilities is carried out);
7) implementation of measures to ensure biological safety, monitoring, treatment of domestic terrestrial animals, the results of research on: the relevant species and categories of domestic terrestrial animals kept at the facility; type of production; type and size of power.
8) results of inspections carried out at the facility.
Separate requirements for traceability of domestic terrestrial animals and reproductive material are defined separately.
The grounds and procedure for quarantining animals have been established.
The basic principles of ensuring the welfare of animals during keeping are determined. In particular, it is the duty of owners (holders) of animals not to cause animals unnecessary pain, suffering, injury. There are separate requirements for keeping pets at facilities, requirements for facilities where pets are kept, for feeding, watering and use of other substances.
The obligation to obtain an operating permit for facilities intended for:
1) keeping, breeding, rearing, collection and / or circulation of domestic terrestrial animals;
2) keeping, breeding, rearing and / or circulation of bees;
3) collection, production, processing and / or circulation of reproductive material;
4) maintenance, breeding, cultivation and / or circulation of aquaculture facilities;
5) destruction and / or utilization of animals, reproductive material, pathological material, biological products in order to combat animal diseases.
The procedure for issuing such a permit and the amount of payment for its issuance have been established.
The procedure for state registration of livestock facilities and market operators has been determined.
Separate sections of the bill are devoted to the issues of diagnostics and laboratory tests, production, circulation and use of veterinary drugs, implementation of veterinary practice.
State control over compliance with the legislation on veterinary medicine will be carried out in accordance with the Law of Ukraine "On state control over compliance with the legislation on food, feed, animal by-products and veterinary medicine."
Lawyer's comment:
In general, the bill contains many positive innovations and modernizes the requirements of legislation in the field of veterinary medicine. It is too early to analyze its situation in detail, because it is only a project developed by the State Food and Consumer Service. In the future, it will be submitted for consideration and approval to the Cabinet, and then put to a vote in the Verkhovna Rada. There are still a lot of changes to be made in this way.
(Number of ratings: 4 average: 4.50 of 5)
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