Russia: Issue 4 November 2016

New Requirements for Chemicals Products in the Russian Federation

Technical Regulation on Chemical Product Safety will come into effect as of 1 July 2021. It introduces requirements for chemicals products placed on the market in the Russian Federation.

It includes rules and requirements for identification, conformity assessment, terminology, packaging and labelling of chemical products. This regulation also lists chemicals to which its provisions do not apply.

Requirements for production, storage, transportation, sales and utilisation are set out in separate technical regulations for certain types of chemicals. In case such separate technical regulations do not specify requirements for the classification, warning labeling and material safety data sheets for those certain types of chemicals, the provisions of the Technical Regulation on Chemical Product Safety are to apply.

Law:  Decree of the Government of the Russian Federation N 1019 of 7 October 2016 on the Technical Regulation on Chemical Product Safety.

Application Procedures Defined for Laws and Regulations on Medical Waste Management

Federal Service on the Supervision of the Use of Natural Resources (Rosprirodnadzor) reported that Russian Federation Citizens Safety and Health Federal Act defined which types of waste belong to medical waste.

Medical waste must be collected, used, neutralised, disposed, stored, transported, kept in record and utilised pursuant to the applicable legal requirements to ensure hygiene well-being of the population. Five hazard classes (A, B, C, D, E) are defined for medical waste. They are categorized according to epidemiological, toxic and radioactive danger and negative environmental effects.

Therefore, Federal Law on Industrial and Consumption Wastes and waste regulations of Ministry of Natural Resources and Environment are not valid for medical waste except the abovementioned neutralised medical waste. The legislation is valid only for neutralised in prescribed by law order medical waste and neutralisation waste.

Federal Service on the Supervision of the Use of Natural Resources (Rosprirodnadzor) Letter N АА-03-03-32/13510 of 8 June 2016 Concerning the Request.

The  Prosecutor General’s Office  of the Russian Federation sets out the position regarding the issue of registration certificates for medical devices to private entrepreneurs

The Prosecutor General's Office acknowledges that the Rules for the registration, and safety assessment, quality and effectiveness of medical devices, adopted by  Decision of the Eurasian Economic Commission Council of February, 12, 2016 N 46 allow the issue of registration certificates for medical devices to legal persons as well as to private entrepreneurs (sole traders).  However, this Decision has not yet entered into force.

Therefore, state registration of medical devices is currently to be regulated by the norms of Federal Law ‘"On the Fundamentals of Health Protection in the Russian Federation" and the Russian Federation Government Resolution of 27 December 2012 No. 1416  “Rules for state registration of medical devices”

Law: Letter of the Federal Service on Surveillance in Healthcare (Roszdravnadzor) of October 26, 2016 No. 01И-2115/16 “On private entrepreneurs”

Fires as well as litter and grass burning are forbidden in common-use lands of public settlements

Decree introducing amendments to the Fire Safety Rules of the Russian Federation was adopted.

In cases of increased fire hazard in certain areas, the authorities may set a special-purpose fire safety regime.

In addition, it is forbidden to change the documented class of a building’s fire hazard, without performing an expert examination of a building’s planning documentation.

The decree imposed the following requirements:

  • Banners must comply with the fire safety rules applicable to external walls. 
  • Banners must be made of fire-resistant or low-combustible materials and located in the way that in case of fire would not prevent or hinder airing of stairwells or wall openings out of smoke and products of combustion. 
  • Another point that concerns buildings is that open-way electric cabling in ventilated cavities of all types of curtain wall systems is prohibited.
  • Water storage towers must be adapted to all-season utilization by fire-fighting machinery. The use of water from storage towers for manufacturing or other purposes is forbidden. Facilities must provide autonomous reserve power supply sources to ensure non-interrupted power supply of water storage towers.

Temporary constructions must be erected next to firewalls or not closer than 15 meters to other buildings.

The decree comes into effect 12 months after its official publication.

Law:  Decree of the Government of the Russian Federation N 947 of 20 September 2016 On Introducing Amendments to Fire Safety Rules of the Russian Federation.