| Brazil |
BRA/480 |
Personal protective equipment
Brazil
Personal protective equipment
Draft Ministerial Act on conformity assessment procedures for Personal Protective Equipment (PPE) by a compulsory third party certification, carried out by an accredited body to determine that relevant requirements within the Brazilian System of Conformity Assessment - SBAC are fulfilled. |
4/10/2012 |
5/19/2012 |
| Brazil |
BRA/479 |
Sanitizing products
Brazil
Sanitizing products
This draft technical regulation establishes revision, modification and update of procedures and technical requirements for the registration of sanitizing products that are corrosive to the skin and can lead to irreversible eye injury.
All products manufactured under the Resolutions RDC no 163, 11 September 2001, and RDC No 240, 6 October 2004, can be marketed until their expiration dates.
It revokes Anvisa´s Resolution RDC no 163, 11 September 2001, RDC no 240, 6 October 2004, and Ordinances no 08 MS/SNVS, 10 April 1987, and 13 MS/SNVS, 20 June 1988. |
3/29/2012 |
5/19/2012 |
| Brazil |
BRA/482 |
Pharmaceutical products
Brazil
Pharmaceutical products
This draft technical regulation establishes the prioritization of technical analysis of petitions within the General Drugs Registration Office.
The criteria on this draft resolution were defined according to public relevancy to ensure or improve access to pharmaceutical care.
The prioritization of the technical analysis of petition applies to the drugs that fit in one or more of the criteria established in article 3 of the draft resolution and that achieve the minimum score of 10, as set out in its Annex I.
It revokes Resolution RDC No 28, 4 April 2007 |
5/9/2012 |
5/20/2012 |
| Trinidad and Tobago |
TTO/106 |
Thermal Solar Systems and Components
Trinidad and Tobago
Thermal Solar Systems and Components
This Trinidad and Tobago Standard specifies requirements on durability (including mechanical strength), reliability and safety for liquid heating solar collectors. It also includes provisions for evaluation of conformity to these requirements.
It is not applicable to those collectors, in which the thermal storage unit is an integral part of the collector to such an extent, that the collection process cannot be separated from the storage process for the purpose of making measurements of these two processes. It is basically applicable to concentrating collectors; thermal performance testing as given in EN 12975-2:2006, 6.3. (quasi dynamic testing) is also applicable to most concentrating collector designs, from stationary non-imaging concentrators as CPCs to high concentrating tracking designs.
Collectors that are custom-built (built in, roof integrated collectors that do not comprise factory made modules and are assembled directly on the place of installation) cannot be tested in their actual form for durability, reliability and thermal performance according to this standard. Instead, a module with the same structure as the ready collector is tested. The module gross area in the case of custom built collectors should be at least 2 m². The test is valid only for larger collectors, than the tested module. |
4/10/2012 |
5/23/2012 |
| Canada |
CAN/361 |
Human blood
Canada
Human blood
Blood and blood components are currently regulated as drugs by a combination of provisions that are not specific to blood, found in several Divisions of Part C of the Food and Drug Regulations (FDR).
The purpose of this initiative is to introduce in the Food and Drugs Act (FDA) specific Regulations for human blood and its components intended for transfusion or for further manufacturing into human drugs. The proposed regulatory framework would address the safety, efficacy and quality of blood and its components with requirements related to the donor suitability assessment, collection, testing, labelling, storage, distribution and importation, for all establishments performing these activities. The proposed regulatory initiative would consolidate the existing requirements in new Regulations specific for blood and its components, apply to all establishments that perform any of the regulated activities, and apply the level of oversight that is commensurate with the level of risk of the activities performed by each establishment. |
3/22/2012 |
5/24/2012 |
| Canada |
CAN/357 |
Radio communications Equipment
Canada
Radio communications Equipment
Notice is hereby given by Industry Canada that the following radio standards specifications (RSSs) come into force effective immediately:
- Radio Standards Specification RSS-111, Issue 4: Broadband Public Safety Equipment Operating in the Band 4940-4990 MHz, which sets out the requirements for certification of radio transmitters and receivers in the band 4940-4990 MHz for public safety applications;
- Radio Standards Specification RSS-182, Issue 5: Maritime Radio Transmitters and Receivers in the Band 156-162.5 MHz, which sets out the requirements for certification of radio transmitters and receivers in the maritime service in the band 156-162.5 MHz; and
- Radio Standards Specification RSS-288, Issue 1: Global Maritime Distress and Safety System (GMDSS), which sets out the requirements for certification of the shipborne radio communication equipment that meets the requirements of the GMDSS.
RSS-111 was updated to clarify the requirements for equipment with multiple transmitters. RSS-182 was updated to provide the new requirements regarding the Automatic Identification
System (AIS SART). RSS-288 was renumbered from RSS-188 to reflect the numbering convention for licence-exempt equipment and to include the new requirements from international standards. |
2/14/2012 |
5/27/2012 |
| Brazil |
BRA/477 |
Baby carriages (HS 8715)
Brazil
Baby carriages (HS 8715)
Conformity Assessment requirements for Baby Carriages. |
3/28/2012 |
5/28/2012 |
| Colombia |
COL/168 |
Oils, fats and all packaged or wrapped foods
Colombia
Oils, fats and all packaged or wrapped foods
The notified draft Resolution covers the following: Purpose; Scope; Exceptions; Definitions; Principles; Requirements for foods containing trans fats and saturated fats; Nutrition labelling and marking; Inspection, monitoring, control and penalties; Review and updating; Disclosure of procedures; Notification and period of validity. |
3/5/2012 |
5/29/2012 |
| Canada |
CAN/362 |
Explosives
Canada
Explosives
The Explosives Regulations are out of date and make it difficult for regulatees to determine their obligations in order to comply with the Regulations. Several areas of industrial safety and security must be enhanced to be in line with industry best practices such as quality management systems and personnel training, and certain gaps must be filled in order to ensure an appropriate level of safety and security for the industry, its workers, and the public at large.
Modernization of the Regulations requires a complete rewrite of the legal text, and introduces a minimal number of new requirements. The Explosives Act and Regulations are outdated. The modernized Regulations would better reflect modern industry practices and standards.
With the exception of regulatory requirements related to the implementation of outstanding obligations under the Public Safety Act, the modernization initiative does not introduce new requirements other than changes to reflect modern practices. The most important changes being made are:
- Enhanced management of operating procedures for processes and better staff training;
- Requirement of fire safety plans and, under certain circumstances, of decommissioning plans;
- Tighter control on the packaging of consumer fireworks (e.g. roman candles, fountains);
- Distribution of safety information to consumers;
- Clarification of requirements applicable to retail sales establishments (e.g. requirement of displays for sale for consumer fireworks);
- Clarification and strengthening of requirements applicable to the use of consumer fireworks; and
- New packaging standards to be met by sellers of industrial explosives (e.g. sellers must mark licence or authorization number on inner packaging).
As well, the security of explosives is to be strengthened by:
- introducing a regime of export and in transit transportation permits and requiring importers and exporters to provide additional information;
- requiring a tracking and communication system in vehicles carrying large quantities of explosives;
- lowering magazine storage exemption limits, which will vary by type of explosive;
- requiring security plans detailing measures to be taken to prevent and react to security incidents;
- requiring a key control plan for licensed magazines; and
- requiring security screening of personnel who could have access to high hazard explosives types E (high explosives), I (initiation systems) and D (military and law enforcement explosives). |
4/4/2012 |
5/31/2012 |
| Mexico |
MEX/228 |
Agricultural and fisheries products
Mexico
Agricultural and fisheries products
The notified Standard applies to agricultural and fisheries products marketed in Mexican national territory and intended for distribution and sales centres or the end consumer. |
4/10/2012 |
6/1/2012 |
| Canada |
CAN/363 |
On-road heavy-duty vehicles and engines
Canada
On-road heavy-duty vehicles and engines
Greenhouse gases (GHGs) are primary contributors to climate change. The most significant sources of GHG emissions are anthropogenic, mostly as a result of combustion of fossil fuels. The emissions of GHGs have been increasing significantly since the industrial revolution and this trend is likely to continue if no action is taken.
Transportation is one of the largest sources of GHG emissions in Canada, accounting for about 28% of total emissions in 2009. Heavy-duty vehicles accounted for around 7% of total GHG emissions or 24% of transportation emissions. Accordingly, taking action to reduce emissions from new on-road heavy-duty vehicles is an essential element of the Government of Canada's strategy to reduce air pollutant and GHG emissions to protect the environment and the health of Canadians.
The objective of the proposed Heavy-Duty Vehicles Greenhouse Gas Emission Regulations (the proposed Regulations), under CEPA 1999, is to reduce GHG emissions by establishing mandatory GHG emission standards for new on-road heavy-duty vehicles and engines of the 2014 and later model years that are aligned with U.S. standards. The development of common North America standards will provide a level playing field that will lead North American manufacturers to produce more advanced vehicles, which enhances their competitiveness.
The proposed Regulations would introduce progressively more stringent GHG emission standards for new on-road heavy-duty vehicles and engines that would align with the national GHG emission standards and test procedures of the United States Environmental Protection Agency for the 2014 and later model years. The proposed Regulations would apply to companies manufacturing and importing new on-road heavy-duty vehicles and engines for the purpose of sale into Canada. It would reduce greenhouse gas emissions from the whole range of new on-road heavy-duty vehicles from full-size pick-up trucks and vans to road tractors (i.e., semi-trucks) and buses, as well as a wide variety of vocational vehicles such as: freight, delivery, service, cement, garbage and dump trucks. The standards in the proposed Regulations would address emissions of CO2, N2O and CH4 from heavy-duty vehicles and engines and would also include measures to require reductions in leakage of the hydrofluorocarbon refrigerant used in cabin air-conditioning systems.
The proposed Regulations also include provisions that establish compliance flexibilities designed to provide appropriate lead-time for technological improvements and a smooth transition to a more stringent regulatory program. These flexibilities include a CO2 credit system for generating, banking and trading emission credits that could be used to offset any emission deficits incurred. Credits would be obtained by companies whose fleet emission levels fall below the applicable standard, while deficits would be incurred by companies whose fleet emissions exceed the applicable standard. Flexibilities also include additional credits for vehicles with advanced and innovative technology vehicles. Companies would also be required to submit annual reports and to maintain records relating to the GHG emission performance of their fleets. |
4/23/2012 |
6/13/2012 |
| Chile |
CHL/198 |
LED lighting chains
Chile
LED lighting chains
The notified Protocol establishes the certification procedure and minimum safety requirements for luminaires for household and similar purposes, in accordance with the scope and field of application of International Electrotechnical Commission (IEC) Standard No. 60598-1:2008-04. |
4/26/2012 |
6/15/2012 |
| Chile |
CHL/199 |
Electric hot water bottles
Chile
Electric hot water bottles
The notified Protocol establishes the certification procedure and minimum safety requirements for electrical appliances for household and similar purposes, in accordance with the scope and field of application of International Electrotechnical Commission (IEC) Standard No. 60335-1:2010-05. |
4/25/2012 |
6/15/2012 |
| Chile |
CHL/195 |
Electronic ballasts for fluorescent lamps and electromagnetic ballasts for fluorescent lamps
Chile
Electronic ballasts for fluorescent lamps and electromagnetic ballasts for fluorescent lamps
The notified Protocol establishes the energy efficiency labelling certification procedure for the following products:
- electromagnetic ballasts for fluorescent lamps
- electronic ballasts for fluorescent lamps
which operate with the following fluorescent lamps:
- linear lamps
- single-capped lamps without integrated ballasts (compact (CFLs) and circular lamps). |
4/17/2012 |
6/18/2012 |
| Chile |
CHL/194 |
Electronic ballasts for fluorescent lamps
Chile
Electronic ballasts for fluorescent lamps
The notified Protocol establishes the certification procedure for electronic ballasts for fluorescent lamps, in accordance with the scope and field of application of International Electrotechnical Commission Standard No. 61347-2-3:2011-05 "Particular requirements for a.c.- and/or d.c.-supplied electronic control gear for fluorescent lamps". |
4/17/2012 |
6/18/2012 |
| Chile |
CHL/193 |
Condensing water heaters
Chile
Condensing water heaters
The notified Protocol establishes the certification procedure for gas-fired instantaneous condensing water heaters with an output of up to 45 kW (for domestic use) or of over 45 kW and up to 70 kW (for commercial use), in accordance with the scope and coverage of Chilean Standard (NCh) No. 1938.Of2005, Standard UNE-EN 677:1998, and Standards UNE-EN 26:1997/A2:2004 and UNE-EN 26:1997/A3:2007 which amend European Standard UNE-EN 26:1997. |
4/13/2012 |
6/18/2012 |
| Chile |
CHL/196 |
Self-ballasted LED lamps for general lighting services
Chile
Self-ballasted LED lamps for general lighting services
The notified Protocol establishes the safety certification procedure and interchangeability requirements for self-ballasted LED lamps for domestic and similar general lighting purposes, with a rated wattage of up to 60 W, a rated voltage of between 50 V and 250 V and lamp caps B15d, B22d, E11, E12, E14, E17, E26, E27, GU10, GZ10 or GX53, in accordance with the scope and field of application of International Electrotechnical Commission (IEC) Standard No. 62560 2011-02; "Self-ballasted LED lamps for general lighting services by voltage > 50 V - Safety specifications". |
4/17/2012 |
6/18/2012 |
| Chile |
CHL/197 |
Self-ballasted LED lamps for general lighting services
Chile
Self-ballasted LED lamps for general lighting services
The notified Protocol establishes the energy efficiency certification procedure for self-ballasted LED lamps for domestic and similar general lighting purposes, with a rated wattage of up to 60 W, a rated voltage of between 50 V and 250 V and lamp caps B15d, B22d, E11, E12, E14, E17, E26, E27, GU10, GZ10 or GX53, in accordance with the scope and field of application of International Electrotechnical Commission Standard/Publicly Available Specification (IEC/PAS) No. 62612 2009-06 "Self-ballasted LED lamps for general lighting services - Performance requirements". |
4/17/2012 |
6/18/2012 |
| Paraguay |
PRY/56 |
Potatoes (Solanum tuberosum)
Paraguay
Potatoes (Solanum tuberosum)
The notified draft Technical Regulation applies to all domestically produced or imported potato tubers for consumption which are marketed in Paraguay. It also applies to potato tubers for export. |
4/20/2012 |
6/20/2012 |
| Paraguay |
PRY/58 |
Paper for baking and for hot filtration
Paraguay
Paper for baking and for hot filtration
The notified Technical Regulation applies to paper for baking and for hot filtration and to cellulose filter media (materials weighing more than 500g/m2) intended to come into contact with liquid food. |
4/20/2012 |
6/20/2012 |
| Paraguay |
PRY/57 |
Cellulosic packaging and equipment that come into contact with food
Paraguay
Cellulosic packaging and equipment that come into contact with food
The notified Technical Regulation applies to packaging and equipment the surface of which that comes into contact with food or food raw materials is of cellulose or of cellulose coated or treated with the waxes, paraffins, mineral oils or mineral pigments specified in Part II of the text. The Regulation also applies to packaging and equipment which are composed of several layers of either the same material or different materials (multilayers) and meet the requirements set forth in point 1.1 of Part 1 thereof. Moreover, the Regulation is applicable to the cellulosic fibres obtained from recycled material specified in point 1.2 of Part II: "Positive list of components of cellulosic packaging and equipment that come into contact with food". |
4/20/2012 |
6/20/2012 |
| Colombia |
COL/170 |
Nutrient-added foods
Colombia
Nutrient-added foods
The notified draft Resolution covers the following: Purpose; Scope; Definitions; General principles for the addition of nutrients to foods; Essential nutrients; Prohibitions; Specific requirements; Labelling; Control systems; Inspection, monitoring, control and penalties; Review and updating; Notification and period of validity. |
4/4/2012 |
6/26/2012 |
| Colombia |
COL/169 |
Baby and infant foods
Colombia
Baby and infant foods
The notified draft Resolution covers the following: Purpose; Scope; Definitions; Prohibitions; Contaminants and additives; Classification of baby and infant foods; Specific prohibition; General conditions; Essential composition and quality factors; Food additives; Microbiological requirements; Packaging conditions; Labelling; Inspection, monitoring, control and penalties; Review and updating; Notification and period of validity. |
4/4/2012 |
6/26/2012 |
| Guatemala |
GTM/78 |
Animal feed
Guatemala
Animal feed
The notified Technical Regulation establishes the general provisions concerning the manufacturing and hygiene practices for products used in animal feed with a view to ensuring its safety and quality. The Regulation applies to the animal feed industry and covers the marketing, reception and handling of raw materials and other ingredients, processing (grinding, incorporation, mixing, pelleting, extrusion, blanching or flushing, packaging) and the handling, storage, labelling and distribution of finished products. Plants engaged in the processing of animal by-products not intended for human consumption (rendering) do not fall within the purview of this Regulation. |
5/1/2012 |
7/1/2012 |
| Canada |
CAN/364 |
Prescription status of medicinal ingredients for human use and for veterinary use
Canada
Prescription status of medicinal ingredients for human use and for veterinary use
As part of the Jobs, Growth and Long-term Prosperity Act, the government of Canada is making amendments to the Food and Drugs Act to streamline the regulatory process to establish the prescription status of a drug while maintaining the same scientific rigour based on well-established and publicly available criteria.
These amendments found in Division 19 of Part 4 will permit the Minister of Health to establish a list of prescription drugs or classes of prescription drugs and to provide that the list may be incorporated by reference.
The proposed changes to the Food and Drug Act will make the process of assigning prescription status more efficient by removing the requirement for a regulatory amendment and maintaining the list of prescription drugs administratively.
These changes will not affect the way the sale, direct to consumer advertising, or importation of prescription drugs is managed in Canada. This new approach will not impact the safety and efficacy of drugs in Canada. All drug submissions to Health Canada will continue to be subject to rigorous safety, efficacy and quality assessments prior to approval. |
5/8/2012 |
7/2/2012 |
| Colombia |
COL/171 |
Mineral products
Colombia
Mineral products
The notified draft Resolution covers the following: Purpose; General provisions; Definitions; Liability; Training; Personal protective equipment; Occupational health committee; Competent authorities; Records and plans; Preventive and occupational medicine; Investigation of industrial accidents and incidents; Provisions common to all underground work; Special provisions for mines with firedamp hazards; Dust control, combustible dust, particulate matter; Structural support; Transport; Locomotives; Conveyor belts; Armoured conveyor; Silos and hoppers; Explosives: storage, use; Special provisions for work involving dust and firedamp hazards; Electrical installations: construction, operation and maintenance; Underground power plants; Machinery and tools; Winches; Cables; Fire protection and extinction; Hygiene and working conditions: lighting, noise, temperature, signage; Drainage: surface water and groundwater; Final provisions; Penalties; and Period of validity and derogations. |
4/10/2012 |
7/2/2012 |
| Jamaica |
JAM/31 |
Tobacco products
Jamaica
Tobacco products
This document specifies the information, the method of display of such information and the wording and presentation of health warnings to be included on the labels of retail packages of tobacco products intended to be sold in Jamaica. Specifications in this document include terms and definitions, general and detailed requirements, labelling, responsibility for labelling, approval of labels, graphic health warnings for use on packages and cartons of smoked and smokeless tobacco products and schedule of rotation of health warnings. |
5/11/2012 |
7/11/2012 |
| Colombia |
COL/172 |
Ceramic tiles (HS 6907.10, 6907.90, 6908.10, 6908.90)
Colombia
Ceramic tiles (HS 6907.10, 6907.90, 6908.10, 6908.90)
The notified draft Resolution covers the following: Purpose; Scope; Exceptions; Definitions and acronyms; General labelling requirements; Minimum labelling information for ceramic tiles; Reference to Colombian Technical Standards; Conformity assessment procedure; Monitoring and inspection bodies; Penalty system; Review and updating; Transitional regime; Notification; Entry into force; Annexes; and Derogations. |
4/23/2012 |
7/17/2012 |
| Colombia |
COL/173 |
Agricultural inputs
Colombia
Agricultural inputs
The notified draft Resolution covers the following: Purpose; Scope; Definitions; Importation of agricultural inputs for direct use; Registration of agricultural input importers; Registration application procedures; Issuance and validity of, amendments to and cancellation of registration; Obligations of the registrant; Prohibitions applicable to unions, federations and associations of producers registered as importers of agricultural inputs for direct use; Post-registration monitoring activities; Official control; Penalties; and Period of validity. |
4/26/2012 |
7/18/2012 |
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