REGULATORY NEWS

EU Updates Requirements for Migration of Dangerous Substances from Toys

European Committee for standardization (CEN) published EN 71-3 “Safety of toys - Part 3: Migration of certain elements” in April 2019. However, its announcement was planned for late July. The main goal of this standard is to minimize the risk of dangerous substances that children could get from toys. This standard specifies requirements and test methods for the migration of the following chemical elements from toys: aluminium antimony arsenic barium boron cadmium chromium (III) chromium (VI) cobalt copper lead manganese, mercury nickel selenium strontium tin organic tin zinc The EN 71-3 Standard divides toys materials into three categories and specifies the requirements and test methods for

Results of Inspections of the Accredited Certification Bodies, Laboratories, and Organizations in Ru

The Russian Accreditation Authority (Federal Service for Accreditation—RusAccreditation—inspected the activities of Russian certification bodies, organizations, and testing laboratories for possible violations. During May and June 2019, RusAccreditation conducted 183 inspections. The inspections were made to: Eliminate non-compliance with accreditation criteria Assess the implementation of previously issued injunctions Reveal possible violations by accredited individuals As a result of the inspection of certification authorities: 8 accreditation authorities received temporary injunctions in order to fix violations 6 accreditation authorities were suspended (including 1 certification body, 4

Panama Extends Compliance Deadlines for Certain Household Equipment

On June 21, 2019, the Panamanian Ministry of Commerce and Industry approved two Resolutions № 46 and 47. The documents are aimed at extending the compliance deadlines set out by Resolutions on Technical Regulations on Energy Efficiency and Labeling of Refrigerators, Freezers and Three-phase Squirrel-cage Induction Motors. It should be considered that the above-mentioned requirements for the minimum energy efficiency levels and labeling as well as restrictions for selling the non-compliant products in Panama will come into force from August 28, 2019. According to Technical Regulations the importers, manufacturers or sellers must comply with three aspects: 1.The Technical Regulations require c

Changes in EU RoHS 2 come in force in July

The EU RoHS Directive 2011/65/EU (also known as RoHS 2) restricting the use of hazardous substances in electrical and electronic equipment has been in force since June 2006 in the entire EU. However, the requirements of the EU RoHS have been applied to manufacturers of electronic equipment gradually as various electrical and electronic equipment (EEE) categories have come into scope one by one over the years. On March 31, 2015, the European Commission added four new phthalate substances to the restricted substances list under Annex II of the EU RoHS Directive 2011/65/EU. An amendment to the EU RoHS Directive 2015/863 was published in the EU Official Journal on June 4, 2015. The new substance

Indonesia Publishes New Technical Regulations on Low-Power Wide-Area Devices

SDPPI of Indonesia published the Regulation #3/2019 on Technical Requirements on Low-Power Wide-Area (LPWA) Devices on May 17, 2019. This regulation contains requirements to LPWA devices that must be met to get access to the market of Indonesia. According to the Regulation, LPWA telecommunication devices are divided into Subscriber station and Base station Both LPWA subscriber station and base station can use NB-IoT (NB1 and NB 2 standards) or LTE-M (M1 or M2 standards). There are two types of requirements for the LPWA devices: General requirements Conformity requirements General requirements include: 1. Power supply It is applicable for devices with AC PSU, that rated voltage should be 220

New Zealand Market Access for Electrical and R&TT Products

In order to access the market of New Zealand, products must get all the required approvals established by the government of the country. Safety approvals The Electrical Regulatory Authorities Council (ERAC) is the regulatory body of electrical safety regulators in New Zealand. ERAC ensures electrical safety regulatory systems are contemporary and harmonized wherever possible. There is a national database where all suppliers and certain types of equipment must be registered prior to being offered for sale. Product categories which fall under the scope of the Safety approval are: Greater than 50 V AC RMS or 120V ripple-free DC (Extra-low voltage) Less than 1000V AC RMS or 1500V ripple-free DC

Brazil Establishes New Energy Efficiency Requirements for Refrigerators and Freezers

On July 31, 2018, the Brazilian Ministry of Energy and Mines adopted Portaria No. 1/2018. The document establishes the Target Program for the energy efficiency of refrigerators and freezers. This Regulation applies to refrigerators and freezers for domestic use, operating on alternating current of 60 Hz and nominal voltages of 127 V or 220 V, or voltage ranges that encompass the same, or direct current operation, which are manufactured, imported, commercialized and/or used in Brazil. It sets out the maximum levels of consumption (C/Cp) for the following product categories, as classified by IEC-62552:2007: minibars refrigerators frost-free refrigerators combined combined frost-free side-by-si

WEBINAR: Guide to Russian Market Access for Radio and Telecom Products

Overview: Most radio and telecom products accessing the market of the Russian Federation must meet regulations and compliance requirements of the Federal Agency of Communication and the Federal Security Service prior to export their new products in Russia. This webinar will cover the main rules of the Russian certification system supported by comments and examples and help you understand the general procedure of Russian market access for R&TT equipment. Join this webinar and learn how to make the import of your products faster with less effort. You will learn: General principles of Russian Telecom Approval for R&TTE FAC certification and FAC declaration procedures. What is the main differenc

Australia Market Access For Electrical and R&TT Products

In order to access the market of Australia, products must get all approvals required by the government of the country. Safety approvals The Electrical Regulatory Authorities Council (ERAC) is the regulatory body of electrical safety regulators in Australia. ERAC ensures electrical safety regulatory systems are contemporary and harmonized wherever possible. There is a national database where all suppliers and certain types of equipment must be registered prior to being offered for sale. Product categories which fall under the scope of the Safety approval are: Greater than 50 V AC RMS or 120V ripple-free DC (Extra-low voltage) Less than 1000V AC RMS or 1500V ripple-free DC (high voltage) In-sc

Indonesia Issues New Regulation for Short-Range Communication Devices

SDPPI of Indonesia published the Regulation #4/2019 on Technical Requirements for Dedicated Short-Range Communication Вevices on May 17, 2019. This regulation applies to DSRC tools or devices that are going to be put to the market of Indonesia and contains general provisions and technical requirements to the equipment. According to this Regulation, DSRC devices include: Road-side Units On-board Units Among the technical requirements that should be considered are the following: 1. Power supply It is applicable for devices with AC PSU with rated voltage of 220 V ± 10% with a frequency of 50 Hz ± 2% The external PSU (AC/DC converter) must not affect the ability of the device to meet all the rel

United States Issues Guidance on Conformity of Medical X-Ray Devices with International Standards

On May 8, 2019, the US Food and Drug Administration (FDA) has issued two final guidance documents regarding X-ray devices designed to more closely align FDA requirements with internationally developed standards: The Guidance “Policy Clarification for Certain Fluoroscopic Equipment Requirements” This guidance covers standards for fluoroscopic equipment, clarifying aspects of US performance requirements: fluoroscopic irradiation time, last image hold, and emergency fluoroscopy mode. The draft guidance was issued in September 2014. The Guidance “Medical X-Ray Imaging Devices Conformance with IEC Standards” The final guidance updates the draft policy issued in August 2016. This Guidance describe

USA Market Access for Electrical and R&TT Products

In order to access the market of the USA, products must be approved according to the existing legislation and get the required document of conformity. Electrical and electronic equipment manufacturers planning to sell their products in the United States must ensure that their equipment doesn't interfere electromagnetically with other products or cause harm. The Federal Communications Commission (FCC) is the regulatory body: responsible for telecommunications type approvals in charge of the development, enforcement, and implementation of regulations set forth by the Congress in the Communications Act of 1934 and the Telecommunications Act of 1996 oversees and enforces requirements for radio d

Philippines Delays Launch of New Medical Device Regulations

To comply with the ASEAN Medical Device Directive (AMDD), the Philippines issued new "Guidelines Governing the Issuance of Authorization for Medical Devices based on the ASEAN Harmonized Technical Requirements". The document governs the notification or registration of medical devices with the Food and Drug Administration (FDA) prior to importation, exportation, marketing, manufacturing, and distribution on the territory of the Philippines (known as Administrative Order 2018-0002 dated January 26, 2018). The FDA of the Philippines intended to implement the first two phases of the new medical device regulatory system on April 11, 2019. However, the implementation date has been delayed. Extra t

Indonesia Publishes New Regulation on Technical Requirements for WLAN Devices

SDPPI of Indonesia published the Regulation #2/2019 on Technical Requirements for WLAN Devices on May 17, 2019. This regulation applies to WLAN tools or devices that are going to be put to the market of Indonesia and contains general provisions and technical requirements. The main technical requirements include: 1. Power supply It is applicable for devices with AC PSU that rated voltage should be 220V ± 10% with a frequency of 50 Hz ± 2% The external PSU (AC/DC converter) must not affect the ability of the device to meet all the relevant technical parameters 2. Non-Ionizing Radiation protection WLAN devices should comply with the requirements of the International Commission on Non-Lonizing R

Indonesia Implements Mandatory National Standards for Audio, Video, and Similar Electronic Apparatus

On June 26, 2018, the Indonesian Ministry of Industry published the Regulation № 15 "Enforcement of Mandatory Indonesian National Standards for Audio Video and Similar Electronic Apparatus". It concerns the products manufactured in Indonesia or imported, distributed, and marketed in the country. From June 26, 2019, products that are in scope of this Regulation will must fulfill SNI requirements and have to undergo conformity evaluation. The regulation includes the following products are: Televisions Television set top boxes DVD Disc Players Blu-rays Head unit mobiles Active speakers Importers and manufacturers are required to obtain a Certificate of Conformity and affix the SNI Mark and othe

Product HS Code Becomes Mandatory in NOM Certificates of Goods Imported to Mexico

On October 23, 2018, the Mexican Secretariat of Economy published an agreement which amends the Mexican Foreign Trade Rules “NOM Agreement”. Changes came into effect on June 3, 2019 and affected all devices submitted for radio and safety type approval in Mexico for NOM standards. The product HS code is now required for all current NOM certificates otherwise they are invalid at customs. This ensures compliance to the relevant NOMs at the point of entry into Mexico. All previously issued certificates must be updated with the HS code. The update process is administrative only and will not require re-testing or re-certification. For manufacturers of imported spare parts, it is important to note

Energy Efficiency Requirements for Air Conditioners Come Into Force in Brazil

On July 31, 2018, the Brazilian Ministry of Energy and Mines enacted Portaria No. 2 approving the Target Program for the energy efficiency of air conditioners. This Regulation applies to air conditioners operating in an alternating current of 60 Hz and nominal voltage 127-220V and imported or made domestically for use in Brazil. The list includes the following types of the equipment: mono-block air conditioners window or wall air conditioners single or split hi-wall air conditioners ceiling and floor air conditioners from a single evaporator unit Air conditioners with water cooler condensers are excluded from the scope. The minimum energy efficiency levels for window air conditioners as foll

Main Safety Requirements for Toys Entering EAEU Market

When accessing the EAEU market, toys manufacturers shall ensure that their products have been designed and produced in accordance with the requirements set out in the EAEU TR 008/2011 “On the Safety of Toys”. The technical regulations contain basic health and safety requirements that should be taken into consideration. The compliance with the requirements of the EAEU TR 008/2011 is carried out with regard to: Applied materials Toys for children up to 3 years old should not contain natural fur, natural leather, glass, porcelain, and brushed materials (rubber, cardboard and paper). It is also not allowed to use recycled materials obtained as a result of recycling of used materials. For produc

Slovenia Updates RoHS Starting from June 2019

Placing or use of certain dangerous substances and preparations (ROHS) on the Slovenian market is regulated by the Ordinance on Restricting the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (published in the Official Gazette of the Republic of Slovenia, Uradni List № 102/2012) issued by the Minister of Health. This Regulation lays down rules and special conditions for the use of certain hazardous substances in electrical and electronic equipment (EEE) in accordance with Directive 2011/65/EC. The regulations are based on the Rules issued by the Minister of Health. On May 17, 2019, the Slovenian Ministry of Health published Uradni List № 32/2019 (the Rule) which ap

Mexico Issues Standard on Energy Efficiency of Refrigerators and Freezers

On June 28, 2018, the Mexican National Commission for Energy Efficiency (CONUEE) and the National Consultative Committee of Standards for the Preservation and Rational Use of Energy Resources (CCNNPURRE) published Standard NOM-015-ENER-2018 on Energy Efficiency of Refrigerators and Freezers. This standard sets out the maximum power consumption limits for refrigerators, refrigerators/freezers, and household freezers. It applies to domestic refrigerators, freezer/refrigerators for domestic use up to 1104 L and domestic freezers up to 850 L operated by hermetic compressor marketed in the national territory. The following equipment is excluded from the scope: Products included in Official Mexica

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