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ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of November 4, 2016 No. 1212

About approval of Methodology of risks assessment for nonfood consumer goods and the choice of the adjusting measures

For the purpose of execution of provisions of the Law No. 422-XVI of December 22, 2006 on general safety of products (The official monitor of the Republic of Moldova, 2007, Art. No. 36-38, 145), with subsequent changes and amendments, and parts (5) article 24 of the Law No. 7 of February 26, 2016 on supervision of the market concerning realization of nonfood products (The official monitor of the Republic of Moldova, 2016, Art. No. 79-89, 146) DECIDES: the Government

1. Approve risks assessment Methodology for nonfood consumer goods and the choice of the adjusting measures it (is applied).

2. To supervision bodies behind the market specified in the Law No. 7 of February 26, 2016 on supervision of the market concerning realization of nonfood products to take necessary measures for enforcement of the approved Methodology.

3. To impose control over the implementation of this resolution on the Ministry of Economics.

4. This resolution becomes effective since April 1, 2017.

Prime Minister

Paweê Phillip

Countersigns:

deputy. Prime Minister, Minister of Economic Affairs

 

Octavian Kalmyk

Approved by the Order of the Government of the Republic of Moldova of November 4, 2016 No. 1212

Risks assessment methodology for nonfood consumer goods and the choice of the adjusting measures

This Methodology shifts part IV of the Section V of the Decision of the European commission of December 16, 2009 about establishment of the guidelines for management of the operational information system of Community "RAPEX" founded based on Article 12, and the procedure of the notification established based on Article 11 of the Directive 2001/95/EC of the European parliament and Council of December 3, 2001 about general safety of products published in the Official magazine of the European Union by L 22 of January 26, 2010.

I. General provisions

1. The risks assessment methodology for nonfood consumer goods and the choice of the adjusting measures (further – Methodology) establishes methodological basis of assessment of risk level of the nonfoods (further – goods) intended for consumers conditions under which bodies for supervision of the market, in the field of the competence, choose and apply the adjusting measures to sale and use of products which pose threat to public concerns, such as health and safety in general, health and work place safety, consumer protection, environmental protection and safety.

2. In sense of this Methodology the concepts specified in the Law No. 7 of February 26, 2016 on supervision of the market concerning realization of nonfood products and in the Law No. 422-XVI of December 22, 2006 on general safety of products are used.

3. In sense of this Methodology the used concepts have the following value:

sensitivity analysis – risk level change determination if the estimated factors vary;

risk assessment – the procedure of identification and assessment of dangerous factors consisting of three stages:

a) detection of gravity of dangerous factor;

b) determination of probability that the injury owing to detection of dangerous factor will be caused to the consumer;

c) combination of dangerous factor and probability;

risk management – the subsequent actions separate of risk assessment directed to reduction or elimination of risk;

risk level – risk degree which can be "serious", "high", "average" and "low". In case of detection (highest) risk level the risk assessment is considered complete;

dangerous factor – the danger source connected with possibility of damage or causing injury. In case of risk assessment the dangerous factor is quantitatively expressed in value of severity of possible injury or harm;

internal danger of product – the danger created by properties of product;

the risk – represents combination of severity of possible injury for the consumer and probability that this injury will be done. The risk represents the balanced combination of dangerous factors and probability of damnification. The risk does not represent only probability or dangerous factor, and their simultaneous combination;

the scenario of getting injured – describes the accident which happened or which can happen to the consumer owing to consumption (use) of the corresponding product, and also severity of injury of the consumer received or which is possible for receiving from this accident.

4. The estimated risk level for product determines the adjusting measures which will be applied, depending on circumstances, to the total amount of products of certain brand (model, product, modifications) or their parts or series.

5. Risk level is determined by risks assessment which are present or can be present (further – risks assessment).

6. Risk level represents combination of degree of gravity of injury and probability that internal danger of product leads to the actual injury of the consumer.

II. Determination of criteria for evaluation of risks and their degree

See II. Determination of criteria for evaluation of risks and their degree (19Kb In original language)

III. Development of risk assessment

25. For development of the scenario of injury the supervision body behind the market performs the following operations:

1) is described by product and its dangerous factor:

a) the product is described clear. It is established if the dangerous factor is provided by product in general or only its (separable) part;

b) the quantity of dangerous factors which are provided by product (appendix No. 1 to this Methodology) is determined;

c) it is determined regulation (regulations) or the legislation applicable to product.

2) the category of the consumer which should be included in the description of the scenario of injury when using of dangerous product is determined:

a) for the first scenario of injury the user and use of the product intended for the consumer is established;

b) for other scenarios, taking into account other consumers and other types of use (see the table 1).

3) the scenario of injury in case of which the chosen dangerous factor(s) of product are the reason of injury (injuries) or negative consequence(s) for the consumer is established:

a) stages which can lead to injury (injuries) accurately and briefly ("the shortest way of getting injured", "critical path to getting injured") are described. If the scenario represents several accompanying injuries, all of them join in the same scenario;

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