TBT ABSTRACTS FOR THE 01-11-2015 To 30-11-2015 …€¦ · TBT ABSTRACTS FOR THE 01-11-2015 To...

TBT ABSTRACTS FOR THE 01-11-2015 To 30-11-2015

1

TBT

Notification

No

G/TBT/N/ALB/77

Country ALBANIA

Product

The rules of communication, bilateral consultation and decision making related to

environmental permit of type A

Title

Draft Decision of Council of Ministers "On the adoption of rules of communication, bilateral

consultation and decision making related to environmental permit of type A, for the operation

of the installation established in the territory of the Republic of Albania and that there is real

opportunity to create considerably negative effects in the environment of another state or

immediately after it is required by this state" (5 pages, available in Albanian)

Contents

This Draft Decision of Council of Ministers determines what are the procedures to be

followed when an applicant who for an installation of type A requires to be provided with

environmental permission of the type A and is subject to the procedure of environmental

impact assessment in transboundary context must be subject only to the procedures of this

decision on information and public participation.

Last Date

For

Comment

60 days after circulation by WTO Secretariat

2

TBT

Notification

No

G/TBT/N/BRA/654

Country BRAZIL

Product Chapter 30 – Pharmaceutical products. Pharmaceutical products (HS: 30)

Title Draft Ordinance Nº 88, 6 November 2015 (28 pages, in Portuguese)

Contents

Draft technical regulation establishing rules and procedures for antiparasitic products

registration for veterinary use, including labelling requirements according to the rules set by

Decree Nº 5053, 22 April 2004 and additional normative acts, set in Ordinance Nº 88, 6

November 2015, Annex III, to ensure an adequate level of protection for animals, public

health and environment.

It revokes Ordinance MAPA Nº 301, 19 April 1996, and the MAPA/SDA Ordinance Nº 48

12 May 1997.

Last Date

For

Comment

8 January 2016

3

TBT

Notification

No

G/TBT/N/KOR/614

Country REPUBLIC OF KOREA

Product Swab, wallpapers and floor coverings on a base of paper

Title A draft revision for Safety and Quality Mark Criteria for Swab and Wallpapers and Floor

Coverings on a Base of Paper (5 pages, in Korean)

Contents A draft revision for Safety and Quality Mark Criteria for Swab and Wallpapers and Floor

Coverings on a Base of Paper Notice has been revised as follows:

• Swab – Specification of the distance from the edge of stick to cotton to prevent a protrusion

on the cotton tip by its damaged face while using a cotton bud. • Wallpapers and floor coverings on a base of paper – Implementation of safety requirements

for formaldehyde emission and phthalate plasticizers by adding wall coverings for decorative finish (interior film) to the range of wallpapers.

* According to the Safety and Quality Mark System, manufacturers or importers should

indicate labelling of safety or quality if their products are subject to Safety and Quality Mark.

Last Date

for

Comment

60 days from notification

4

TBT

Notification

No

G/TBT/N/KOR/615


Product Quasi-drugs

Title Proposed "Regulation on Quasi-Drug Re-Evaluation Procedures" (8 pages, in Korean)

Contents

With regard to the re-evaluation of quasi-drugs, this proposed regulation establishes the

procedures for the selection of products subject to re-evaluation, application process, scope of

data submission, pre-notification of the re-evaluation results and follow-up measures,

submission of objections, and notification of final results.

Last Date

for

Comment


5

TBT

Notification

No

G/TBT/N/KOR/616


Product Quasi-drugs

Title Proposed amendments to the "Regulation on Quasi-Drug Approval, Notification and Review"

(36 pages, in Korean)

Contents

Expand the designation of products containing problematic ingredients regarding safety and

efficacy: inhalants and other types of products containing polyhexamethylene guanidine

hydrochloride (PHMG), Oligo (2-(2-ethyoxy) ethoxyethylguanidium chloride (PGH),

products containing more than 0.05% of Cetylpyridinium chloride (CPC), and products

containing dipropylisocinchomeronate.

Adjust the allowed range of use for preservatives in quasi-drug by only allowing the use of

methylchloro-isothiazolinone and methylisothia-zolinone for external preparations and under

0.0015%.

For products that are same (in ingredient, specification, dosage, type, efficacy, etc.) as a

quasi-drug that has undergone re-evaluation, mandate the submission of safety and efficacy

data (clinical, toxicity).

Last Date

for

Comment


6

TBT

Notification

No

G/TBT/N/TPKM/222

Country TAIWAN

Product Food additives

Title "Draft of Regulation of the Food Additives Shall Be Conspicuously Labeled the Registration

Number" (1 page, in English)

Contents

Based on the provisions of subparagraph 10 of paragraph 1 of Article 24 of the Act

Governing Food Safety and Sanitation, the MOHW proposes to announce the labeling

requirement of the food additives to enhance product management.

Last Date

for

Comment

60 days from the date of notification

7

TBT

Notification

No

G/TBT/N/KOR/613


Product Electrical appliances

Title Amendment on the Processing Criteria for Electrical Appliances Which Are Inappropriate for

Safety Standards (29 pages, in Korean)

Contents For electrical appliances where safety standards are amended, their processing criteria should

be amended in order to correspond to safety standards if they don't meet safety standards.

Last Date

for

Comment


8

TBT

Notification

No

G/TBT/N/SAU/891

Country KINGDOM OF SAUDI ARABIA

Product ICS: 85.080

Title Facial Tissue – Paper, Two-Ply or More (5 pages, in English)

Contents

Draft no. 30094. This standard is concerned with folded facial tissue – paper, two-ply or more

intended for use as disposable, packed in a suitable box or plastic package and includes

pocket handkerchiefs.

Last Date

for

Comment

60 days from the date of circulation

9

TBT

Notification

No

G/TBT/N/SAU/892

Country KINGDOM OF SAUDI ARABIA

Product ICS: 13.120

Title

The Kingdom of Saudi Arabia / Saudi Standards, Metrology and Quality Organization (SASO)

/ Household and Similar Electrical Appliances – Safety – Part 2-7: Particular Requirements for

Washing Machines (33 pages, in English)

Contents This regulation specifies safety requirements of electric washing machines for household use

for washing clothes and textiles. This standard includes an annex for national modifications.

Last Date

for

Comment


10 TBT G/TBT/N/USA/1048

Notification

No

Country UNITED STATES OF AMERICA

Product High chairs. Equipment for children (ICS: 97.190)

Title Safety Standard for High Chairs (18 pages, in English)

Contents

The Danny Keysar Child Product Safety Notification Act, section 104(b) of the Consumer

Product Safety Improvement Act of 2008 ("CPSIA"; Pub. L. 110-314, 122 Stat. 3016),

requires the United States Consumer Product Safety Commission ("Commission" or "CPSC")

to promulgate consumer product safety standards for durable infant or toddler products. These

standards must be substantially the same as applicable voluntary standards or more stringent

than the voluntary standard if the Commission determines that more stringent requirements

would further reduce the risk of injury associated with a product. In response to the direction

under section 104(b) of the CPSIA, the Commission is proposing a safety standard for high

chairs. The proposed rule would incorporate by reference ASTM F404-15, Standard

Consumer Safety Specification for High Chairs ("ASTM F404-15") into our new regulation

and impose more stringent requirements for rearward stability and warnings on labels and in

instructional literature. In addition, the Commission proposes to amend our regulations to

include the newly proposed high chair standard in the list of notice of requirements ("NORs")

issued by the Commission.

Last Date

for

Comment

25 January 2016

11

TBT

Notification

No

G/TBT/N/USA/1049


Product Refrigerants. Environmental protection (ICS: 13.020), Products of the chemical industry

(ICS: 71.100)

Title Protection of Stratospheric Ozone: Update to the Refrigerant Management Requirements Under

the Clean Air Act (102 pages, in English)

Contents

The Clean Air Act prohibits the knowing release of ozone- depleting and substitute

refrigerants during the course of maintaining, servicing, repairing, or disposing of appliances

or industrial process refrigeration. The existing regulations require that persons servicing or

disposing of air-conditioning and refrigeration equipment observe certain service practices

that reduce emissions of ozone-depleting refrigerant. This proposed rule would update those

existing requirements as well as extend them, as appropriate, to non-ozone- depleting

substitute refrigerants, such as hydrofluorocarbons. The proposed updates include

strengthening leak repair requirements, establishing recordkeeping requirements for the

disposal of appliances containing five to 50 pounds of refrigerant, changes to the technician

certification program, and changes for improved readability, compliance, and restructuring of

the requirements. As a result, this action would reduce emissions of ozone-depleting

substances and gases with high global warming potentials.

Last Date

for

Comment

8 January 2016

12

TBT

Notification

No

G/TBT/N/ARE/292,G/TBT/N/BHR/420, G/TBT/N/KWT/303,

G/TBT/N/OMN/232, G/TBT/N/QAT/417, G/TBT/N/SAU/888,

G/TBT/N/YEM/23

Country UNITED ARAB EMIRATES, KINGDOM OF BAHRAIN, STATE OF KUWAIT, OMAN,

QATAR, KINGDOM OF SAUDI ARABIA, YEMEN

Product Canned tuna (ICS: 67.080)

Title The Cooperation Council for the Arab States of the Gulf Draft Technical Regulation for

"Canned Tuna" (5 pages, in English; 9 pages, in Arabic)

Contents

This draft technical regulation applies to the basic requirements of the concentrates products

where tuna flesh content constitutes less than 50% (m/m)., definitions, requirements, packing

shapes, sampling, method of tests, packaging, transportation, storage and labelling.

Last Date

for

Comment


13

TBT

Notification

No



G/TBT/N/YEM/24



Product Concentrates for carbonated beverages (ICS: 67.080)

Title The Cooperation Council for the Arab States of the Gulf Draft Technical Regulation for

"Concentrates for Carbonated Beverages" (5 pages, in English; 7 pages, in Arabic)

Contents

This draft technical regulation applies to the basic requirements of the concentrates that are

used in the manufacture of soft drinks, definitions, requirements, sampling, method of tests,

packaging, transportation, storage and labelling.

Last Date

for

Comment


14

TBT

Notification

No



G/TBT/N/YEM/25



Product Cinnamon: Sri Lankan type, Seychelles type and Madagascan type (Cinnamomum Zeylanicum

Blume) – Specification (ICS: 67.220.10)

Title

The Cooperation Council for the Arab States of the Gulf Regulation for "Cinnamon: Sri Lankan

Type, Seychelles Type and Madagascan Type (Cinnamomum Zeylanicum Blume) –

Specification" (11 pages, in English; 12 pages, in Arabic)

Contents

This draft technical regulation applies to whole or ground (powdered) cinnamon, of the Sri

Lankan, Madagascan and Seychelles types; this cinnamon is the bark of the tree or shrub

Cinnamomum Zeylanicum Blume, definitions, types and classifications, ground cinnamon,

requirements, sampling, test methods, packaging and marking.

Last Date

for

Comment


15

TBT

Notification

No

G/TBT/N/BRA/653

Country BRAZIL

Product Children's products. Other seats (HS: 940180)

Title Ordinance Nº 555, 29 October 2015 (1 pages, in Portuguese)

Contents Draft technical regulation which establishes technical requirements that provides the criteria

and process that must be met by children's products: infant walkers.

Last Date

for

Comment

7 January 2016

16

TBT

Notification

No

G/TBT/N/CHN/1157

Country CHINA

Product

Medical electron accelerators. Instruments and appliances used in medical, surgical, dental or

veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and

sight-testing instruments (HS: 9018). Radiographic equipment (ICS: 11.040.50)

Title National Standard of the P.R.C. GB15213 Medical Electron Accelerators – Functional

Performance Characteristics and Test Methods (74 pages, in Chinese)

Contents This standard applies to medical electron accelerators which deliver a radiation beam of either

X-radiation or electron radiation.

Last Date

for

Comment

60 days after circulation by the WTO Secretariat

17

TBT

Notification

No

G/TBT/N/CHN/1158

Country CHINA

Product Occupational eye and face protectors. Sunglasses (HS: 900410). Head protective equipment

(ICS: 13.340.20)

Title Standard of the P.R.C. Personal protective equipment – Eye and face protection – Occupational

eye and face protectors – Part 1: Requirements (22 pages, in Chinese)

Contents

This standard specifies the catalogue, basic requirements and special requirements for the

occupational eye and face protectors.

This standard applies to plano power protectors or components used in occupational eye and

face protection, major for industry use.

This standard doesn't apply to:

• sunglasses for general use or eye and face protectors with vision correction • devices intended to control exposure of the eyes of patients during diagnosis or treatment • products intended for direct observation of the sun, such as for solar-eclipse viewing • eye protectors specifically intended for sports • filters and eye protectors against short circuiting arc • equipment for eye and face protection during welding operations

filters and eye protectors against laser radiation

Last Date

for

Comment

60 days after circulation by the WTO Secretariat

18

TBT

Notification

No

G/TBT/N/KOR/612


Product Herbal medicine & herbal medicine preparations

Title Proposed amendments to "The Korean Herbal Pharmacopoeia" (6 pages, in Korean)

Contents This proposed revision sets to improve the quantification assay for Aurum (includes changes

in preparation method for test solution and standard solution).

Last Date

for

Comment


19

TBT

Notification

No

G/TBT/N/USA/1047


Product

Stationary compression ignition (CI) internal combustion engines. Compression-ignition

internal combustion piston engines (diesel or semi-diesel engines) (HS: 8408). Environmental

protection (ICS: 13.020), Air quality (ICS: 13.040)

Title Standards of Performance for Stationary Compression Ignition Internal Combustion Engines (8

pages, in English)

Contents

The Environmental Protection Agency (EPA) is proposing amendments to the standards of

performance for stationary compression ignition (CI) internal combustion engines to allow

manufacturers to design the engines so that operators can temporarily override performance

inducements related to the emission control system for stationary CI internal combustion

engines operating during emergency situations where the operation of the engine or

equipment is needed to protect human life, and to require compliance with Tier 1 emission

standards during such emergencies. The EPA is also proposing to amend the standards of

performance for certain stationary CI internal combustion engines located in remote areas of

Alaska.

Last Date

for

Comment

21/12/2015

20

TBT

Notification

No

G/TBT/N/VNM/78

Country VIET NAM

Product Milk and processed milk products (ICS 67.100.10)

Title

Draft National Technical Regulation Amending and Supplementing a Number of Articles of

QCVN 5-1: 2010/BYT National Technical Regulation for Liquid Milk Products Issued by

Circular No. 30/2010 /TT-BYT dated 2 June 2010 by the Ministry of Health (16 pages, in

Vietnamese)

Contents

This draft regulation amends and supplements a number of articles of QCVN 5-1: 2010/BYT

National Technical Regulation for liquid milk products which specifies food safety criteria

and requirements for management of liquid milk products including pure fresh milk, fresh

milk, reconstituted milk, recombined milk, composite milk, condensed milk, condensed milk

supplemented with vegetable fat.

This draft regulation amended terms and definitions of pure fresh milk, fresh milk,

reconstituted milk, recombined milk, composite milk. It replaced a number of appendixes and

also amended and supplemented articles regulating labelling and conformity declaration to

technical regulation for liquid milk products.

Last Date

for 60 days from the date of notification

Comment

21

TBT

Notification

No

G/TBT/N/CZE/185

Country CZECH REPUBLIC

Product Automatic weighing instruments – catchweighing instruments. Measuring instruments

(ICS: 17.040.30)

Title

Draft – General measure laying down metrological and technical requirements for legal

measuring instruments, including tests for the verification of legal measuring

instruments: "automatic weighing instruments – catchweighing instruments" (11 pages, in

English; 11 pages, in Czech).

Contents

This general measure will lay down the metrological and technical requirements for legal

measuring instruments, including the tests for the verification thereof, which in this case are

automatic weighing instruments – catchweighing instruments.

Last Date

for

Comment

3 January 2016

22

TBT

Notification

No

G/TBT/N/CZE/186


Product Optical radiometers. Measuring instruments (ICS: 17.040.30)

Title

Draft general measure establishing metrological and technical requirements for specified

measurement instruments, including testing methods for the type approval and verification of

legal measuring instruments: "optical radiometers for the spectral range of 400 nm to 2 800 nm

and measurement of emitted radiation in the range 10³ W • m² to 10² W • m²" (15 pages, in

English; 15 pages, in Czech)

Contents

This general measure establishes metrological and technical requirements for legal measuring

instruments, including testing methods for the type approval and verification of the legal

measuring instruments, which in this case are "optical radiometers for the spectral range of

400 nm to 2 800 nm and measurement of emitted radiation in the range 10³ W • m² to 10² W •

m²"..

Last Date

for

Comment

3 January 2016

23

TBT

Notification

No

G/TBT/N/CZE/187


Product Automatic weighing instruments – discontinuous totalisers. Measuring instruments

(ICS: 17.040.30)

Title

Draft – A measure of a general nature laying down metrological and technical requirements for

legal measuring instruments, including tests for the verification of legal measuring

instruments: "automatic weighing instruments – discontinuous totalisers" (8 pages, in English; 8

pages, in Czech)

Contents

This measure of a general nature will lay down the metrological and technical requirements

for legal measuring instruments, including tests for the verification thereof, which in this case

are automatic weighing instruments – continuous totalisers.

Last Date

for

Comment

3 January 2016

24

TBT

Notification

No

G/TBT/N/CZE/188


Product Automatic weighing instruments – instruments for weighing railway vehicles in motion.

Measuring instruments (ICS: 17.040.30)

Title



instruments: "automatic weighing instruments – instruments for weighing railway vehicles in

motion" (10 pages, in English; 10 pages, in Czech)

Contents



automatic weighing instruments – instruments for weighing railway vehicles in motion.

Last Date

for

Comment

3 January 2016

25

TBT

Notification

No

G/TBT/N/CZE/189


Product Automatic weighing instruments – continuous totalisers. Measuring instruments

(ICS: 17.040.30)

Title



instruments: "automatic weighing instruments – continuous totalisers" (10 pages, in English; 9

pages, in Czech)

Contents



automatic weighing instruments – continuous totalisers.

Last Date

for

Comment

3 January 2016

26

TBT

Notification

No

G/TBT/N/CZE/190


Product Automatic weighing instruments – automatic gravimetric filling instruments. Measuring

instruments (ICS: 17.040.30)

Title



instruments: "automatic weighing instruments – automatic gravimetric filling instruments" (8

pages, in Czech; 9 pages, in English)

Contents



automatic weighing instruments – automatic gravimetric filling instruments.

Last Date

for

Comment

3 January 2016

27

TBT

Notification

No

G/TBT/N/JPN/503

Country JAPAN

Product

Fertilizer (HS: 3101, 3103, 3105) or vegetable fertilizers, whether or not mixed together or

chemically treated; fertilizers produced by the mixing or chemical treatment of animal or

vegetable products. (HS:3101), Mineral or chemical fertilizers, phosphatic – HS: 3103, Mineral

or chemical fertilizers containing two or three of the fertilizing elements nitrogen, phosphorus

and potassium; other fertilizers; goods of this Chapter in tablets or similar forms or in packages

of a gross weight not exceeding 10 kg (HS: 3105).

Animal or vegetable fertilizers, whether or not mixed together or chemically treated; fertilizers

produced by the mixing or chemical treatment of animal or vegetable products. (HS: 3101),

Mineral or chemical fertilizers, phosphatic. (HS: 3103), Mineral or chemical fertilizers

containing two or three of the fertilizing elements nitrogen, phosphorus and potassium; other

fertilizers; goods of this Chapter in tablets or similar forms or in packages of a gross weight not

exceeding 10 kg (HS: 3105)

Title Draft Amendment of the Official Specifications for Ordinary Fertilizers, etc. (2 pages, in

English)

Contents Official Specifications to be amended mixed sludge compound fertilizer.

Last Date

for

Comment


28

TBT

Notification

No

G/TBT/N/MEX/296

Country MEXICO

Product National tariff headings concerned: 2709 and 2710 - Petroleum oils and oils obtained from

bituminous minerals, crude.

Title

Norma Oficial Mexicana de Emergencia NOM-EM-005-CRE-2015, Especificaciones de

calidad de los petrolíferos (Emergency Mexican Official Standard NOM-EM-005-CRE-2015,

Quality specifications for petroleum products) (67 pages, in Spanish)

Contents

The notified Emergency Standard is applicable to gasoline, jet fuel, automotive diesel,

agricultural and marine diesel, industrial diesel, fuel oil, domestic diesel fuel, aviation gas,

first-fill gasoline, intermediate fuel oil and LPG throughout the production and supply chain

in national territory

Last Date

for

Comment

30 October 2015

29

TBT

Notification

No

G/TBT/N/USA/1045


Product

Energy labels. Environmental protection (ICS: 13.020), Ventilators. Fans. Air-conditioners

(ICS: 23.120), Kitchen equipment (ICS: 97.040), Domestic, commercial and industrial heating

appliances (ICS: 97.100)

Title Energy Labeling (27 pages, in English)

Contents

The Commission proposes amendments to the Energy Labeling Rule to create requirements

related to a new label database on the Department of Energy's (DOE's) Website, redesign

ceiling fan labels, improve and update the comparability ranges for refrigerator labels, revise

central air conditioner labels in response to new DOE enforcement requirements, improve

water heater labels, and update current plumbing disclosures.

Last Date

for

Comment

11 January 2016

30

TBT

Notification

No

G/TBT/N/USA/1046


Product Fluorescent lamp ballasts – Fluorescent, hot cathode (HS: 853931). Environmental protection

(ICS: 13.020), Test conditions and procedures in general (ICS: 19.020)

Title Energy Conservation Program: Clarification of Test Procedures for Fluorescent Lamp Ballasts

(8 pages, in English)

Contents

The U.S. Department of Energy (DOE) proposes to clarify its test procedures for fluorescent

lamp ballasts established under the Energy Policy and Conservation Act. DOE is proposing to

replace all instances of ballast efficacy factor (BEF) with ballast luminous efficiency (BLE)

in our regulations and to add rounding instructions to the same section for BLE and power

factor. DOE also proposes to clarify the represented value instructions for power factor.

Finally, DOE is proposing to revise Appendix Q to clarify the lamp-ballast pairings for

testing.

Last Date

for

Comment

4 January 2016

31

TBT

Notification

No

G/TBT/N/CRI/152

Country COSTA RICA

Product 17.080

Title

RTCR 477:2015. Metrología. Instrumentos para la Medición de la Velocidad de Vehículos

Automotores en Carretera. Cinemómetros de Tipo Doppler y Láser (Costa Rican Technical

Regulation (RTCR) No. 477:2015: Metrology. Instruments for measuring the speed of motor

vehicles on the road. Doppler and laser speed measurement devices) (25 pages, in Spanish)

Contents

This Regulation establishes the technical and metrological requirements for Doppler and laser

speed measurement devices that are used to control the speed limits established for certain

activities.

Last Date

for

Comment

30 days from the date of notification.

32TBT

Notification G/TBT/N/CRI/153

No

Country COSTA RICA

Product 67.100.30

Title

RTCR 473: 2014 Reglamento Técnico para el queso cottage (Costa Rican Technical

Regulation (RTCR) No. 473:2014, Technical Regulation on cottage cheese) (13 pages, in

Spanish)

Contents The notified technical regulation establishes the characteristics of, and specifications for,

cottage cheese intended for direct consumption or further processing.

Last Date

for

Comment


33

TBT

Notification

No

G/TBT/N/CRI/154

Country COSTA RICA

Product 67.100.30

Title

RTCR 474: 2014 Reglamento Técnico para el queso provolone (Costa Rican Technical

Regulation (RTCR) No. 474:2014, Technical Regulation on Provolone cheese) (15 pages, in

Spanish)

Contents The notified technical regulation establishes the characteristics of, and specifications for,

Provolone cheese intended for direct consumption or further processing.

Last Date

for

Comment


34

TBT

Notification

No

G/TBT/N/BRA/655

Country BRAZIL

Product Monetary update on registration and GMP certification fees related to health products

Title Interministerial Ordinance nº 701, 31 August 2015, regarding a monetary update on registration

and GMP certification fees related to health products in Brazil (4 pages, in Portuguese)

Contents

Interministerial Ordinance nº 701, 31 August 2015, regarding a monetary update on

registration and GMP certification fees related to health products in Brazil.

This Ordinance promoted a monetary update on registration and GMP certification fees

related to health products in Brazil. It was necessary once the values of ANVISA's fees were

obsolete since its creation in 1999, with accumulated losses of 193.5% according to Brazilian

official inflation rate. So it is considered not to be a tribute increase, but a currency value

reconstitution.

Last Date

for

Comment

There is no final date for comments

35

TBT

Notification

No

G/TBT/N/JPN/504

Country JAPAN

Product Pharmaceutical products (HS: 30)

Title Establishment of the Japanese Pharmacopoeia Seventeenth Edition (15 pages, in English)

Contents

Ministry of Health and Labour and Welfare will abolish the Japanese Pharmacopoeia

Sixteenth Edition and establish Seventeenth Edition under the provision of Article 41 of the

act on securing quality, efficacy and safety of pharmaceuticals, medical devices, regenerative

and cellular therapy products, gene therapy products, and cosmetics.

Last Date

for

Comment

60 days from date of circulation

36

TBT

Notification

No

G/TBT/N/KOR/617


Product Cosmetics

Title Proposed amendments to the “Regulation on the color ingredients and standards of cosmetics

(5 pages, in Korean)

Contents This amendment proposes to prohibit the use of the following tar-colorants in cosmetics

categorized as baby products [Annex 1]: RED NO 2(Amaranth), RED NO 102(New Coccine)

Last Date

for

Comment


37

TBT

Notification

No

G/TBT/N/USA/1050


Product Food labeling. Food products in general (ICS: 67.040)

Title Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods (17 pages, in English)

Contents

The Food and Drug Administration (FDA or we) is proposing to establish requirements

concerning "gluten-free" labeling for foods that are fermented or hydrolyzed or that contain

fermented or hydrolyzed ingredients. These additional requirements for the "gluten- free"

labeling rule are needed to help ensure that individuals with celiac disease are not misled and

receive truthful and accurate information with respect to fermented or hydrolyzed foods

labeled as "gluten-free." There is uncertainty in interpreting the results of current gluten test

methods for fermented and hydrolyzed foods on a quantitative basis that equates the test

results in terms of intact gluten. Thus, we propose to evaluate compliance of such fermented

and hydrolyzed foods that bear a "gluten-free" claim with the gluten-free labeling rule based

on records that are made and kept by the manufacturer of the food bearing the "gluten-free"

claim and made available to us for inspection and copying. The records would need to

provide adequate assurance that the food is "gluten-free" in compliance with the gluten-free

food labeling final rule before fermentation or hydrolysis. In addition, the proposed rule

would require the manufacturer of fermented or hydrolyzed foods bearing the "gluten-free"

claim to document that it has adequately evaluated the potential for gluten cross-contact and,

if identified, that the manufacturer has implemented measures to prevent the introduction of

gluten into the food during the manufacturing process. Likewise, manufacturers of foods that

contain fermented or hydrolyzed ingredients and bear the "gluten-free" claim would be

required to make and keep records that demonstrate with adequate assurance that the

fermented or hydrolyzed ingredients are "gluten-free" in compliance with the gluten-free food

labeling final rule. Finally, the proposed rule would state that we would evaluate compliance

of distilled foods by verifying the absence of protein using scientifically valid analytical

methods that can reliably detect the presence of protein or protein fragments in the distilled

food.

Last Date

for

Comment

16 January 2016

38

TBT

Notification

No

G/TBT/N/USA/1051


Product External power supplies. Environmental protection (ICS: 13.020), Miscellaneous domestic and

commercial equipment (ICS: 97.180)

Title Energy Conservation Program: Exempt External Power Supplies Under the EPS Service Parts

Act of 2014 (7 pages, in English)

Contents

The U.S. Department of Energy (DOE) is proposing to codify provisions of the EPS Service

Parts Act of 2014 that exempt from energy conservation standards certain external power

supplies (EPSs) made available by a manufacturer as a service or spare part. Consistent with

that Act, DOE is proposing to require annual reports of the total number of exempt EPS units

sold as service and spare parts that do not meet the relevant energy conservation standards.

Last Date

for

Comment

18 December 2015

39

TBT

Notification

No

G/TBT/N/USA/1052


Product Central air conditioners. Environmental protection (ICS: 13.020), Ventilators. Fans. Air-

conditioners (ICS: 23.120)

Title Energy Conservation Program: Enforcement of Regional Standards for Central Air

Conditioners (18 pages, in English)

Contents

The U.S. Department of Energy (DOE) is proposing requirements related to the enforcement

of regional standards for central air conditioners, as authorized by the Energy Policy and

Conservation Act (EPCA) of 1975.

Last Date

for

Comment

4 January 2016

40

TBT

Notification

No

G/TBT/N/EU/324

Country EUROPEAN UNION

Product Biocidal products

Title

Draft Commission Implementing Regulation amending Implementing Regulation (EU) No

414/2013 specifying a procedure for the authorisation of same biocidal products in accordance

with Regulation (EU) No 528/2012 of the European Parliament and of the Council (5 pages, in

English)

Contents

Commission Implementing Regulation (EU) No 414/2013 specifies a simplified procedure for

granting different authorisations, e.g. to different authorisation holders, of biocidal products

which are identical in respect of everything (having the same properties), except some

administrative details. The notified draft Commission Implementing Regulation introduces

some changes to the authorisation procedure aiming at providing for further simplification

and to better respond to the needs of prospective applicants, in particular, of small and

medium size enterprises (SMEs).

Last Date

for

Comment


41

TBT

Notification

No

G/TBT/N/ARG/297

Country ARGENTINA

Product Low-voltage electrical products

Title

Régimen para la certificación obligatoria del cumplimiento de los requisitos esenciales de

seguridad para los productos eléctricos de baja tensión que se comercializan en el país

(Regime governing the mandatory certification of compliance with the essential safety

requirements for low-voltage electrical products marketed in Argentina) (19 pages, in

Spanish)

Contents

The notified text stems from the restructuring and unification of existing legislation on the

certification of low-voltage electrical products.

Its purpose is to:

• reformulate certain requirements so as to rationalize the implementation of the regime and adapt it to market changes;

• amend the universe of products which, when used professionally or by electrical safety experts, may be subject to alternative means of compliance with the safety requirements;

• establish criteria for forming families of products, with a view to the issuing of a certificate for each of these families;

• establish a single certificate format for each of the authorized modalities; • establish new guidelines for the monitoring of certified products by certification bodies.

In this light, the text expressly repeals the following resolutions:

SICyM Resolution (Resolución) No. 92/1998:

http://www.infoleg.gob.ar/infolegInternet/verNorma.do?id=49285

SICyM Resolution No. 618/1999:


SCDyDC Resolution No. 76/2002 (G/TBT/N/ARG/78):


SCT Resolution No. 96/2003 (G/TBT/N/ARG/149):


SCT Resolution No. 198/2004 (G/TBT/N/ARG/78/Add.1):


It also expressly ratifies the following provisions:

DNCI Provision (Disposición) No. 736/1999:


DNCI Provision No. 1139/1999:


DNCI Provision No. 178/2000 (G/TBT/Notif.00/228):


DNCI Provision No. 613/2003 (G/TBT/N/ARG/126):


DNCI Provision No. 428/2007 (G/TBT/N/ARG/126/Add.1):


DNCI Provision No. 398/2011:


DNCI Provision No. 316/2014 (G/TBT/N/ARG/78/Add.3):


Articles 12, 28, 29, 34, 35, 41 and 42 of the notified text provide details regarding entry into

force.

Last Date

for

Comment

42

TBT

Notification

No

G/TBT/N/CHE/209

Country SWITZERLAND

Product

Active substances:

• Kupferpyrithion: CAS N° 14915-37-8 • Pythium Oligandrum strain M1: not applicable • 2-Methyl-3(2H)-isothiazolon: CAS N° 2682-20-4 • 5-Chlor-2-(4-chlorphenoxy)phenol (DCPP): CAS N° 3380-30-1 • Kaliumsorbat: CAS N° 24634-61-5 • Wasserstoffperoxid: CAS N° 7722-84-1 • Medetomidin: CAS N° 86347-14-0 • Folpet: CAS N° 133-07-3 • Glutaraldehyd: CAS N° 111-30-8 • Clothianidin: CAS N° 210880-92-5 • Propiconazol: CAS N° 60207-90-1 • IPBC: CAS N° 55406-53-6 • Bromadiolon: CAS N° 28772-56-7 • Chlorophacinon: CAS N° 3691-35-8

Coumatetralyl: CAS N° 5836-29-3

Title

Draft of Ordinance of the Federal Office of Public Health (OFOPH) concerning the inscription

of active substances for the use in biocidal products according to the annexe 2 of the Swiss

Ordinance on Biocidal Products (OBP); 31 pages; available in German, French and Italian.

Switzerland harmonises technical regulations in the field of biocidal products with its main

trading partner, the European Union. The approval of substances enables products containing

such substances to be authorized in Switzerland. As from December 2015, Switzerland will

notify approvals of substances if different from the approvals of substances following

Regulation (EU) 528/2012.

Contents

According to art. 9 paragraph 5 letter a of the present OBP the Federal Office of Public

Health is the competent authority to amend the list of active substances for inclusion in

biocidal products. With the OFOPH the following 15 active substances will amend List I:

• Kupferpyrithion: product type 21 • Pythium Oligandrum strain M1: product type 10 • 2-Methyl-3(2H)-isothiazolon: product type 13 • 5-Chlor-2-(4-chlorphenoxy)phenol (DCPP): product types 1, 2 and 4 • Kaliumsorbat: product type 8 • Wasserstoffperoxid: product types 1, 2, 3, 4, 5 and 6

• Medetomidin: product type 21 • Folpet: product types 7 and 9 • Glutaraldehyd: product types 2, 3, 4, 6, 11 and 12 • Clothianidin: product type 18 • Propiconazol: product type 7 • IPBC: product type 13 • Bromadiolon: product type 14 • Chlorophacinon: product type 14

Coumatetralyl: product type 14

Last Date

for

Comment


43

TBT

Notification

No

G/TBT/N/EU/325


Product Hazardous substances

Title

Draft Commission Regulation amending, for the purposes of its adaptation to technical and

scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the

Council on classification, labelling and packaging of substances and mixtures (4 pages + Annex

10 pages, in English)

Contents

The purpose of this draft proposal for a ninth adaptation to technical progress of Regulation

(EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (the

CLP Regulation) is to amend Annex VI to the CLP Regulation in order to include updated

classifications for 47 substances already subject to harmonised classification and to include

new harmonised classifications

The proposal also deletes table 3.2 that contains the lists of harmonised classification and

labelling of hazardous substances which were based on the criteria set out in Annex VI to

Council Directive 67/548/EEC as Directive 67/548/ECC was repealed from 1 June 2015.

Last Date

for

Comment


44

TBT

Notification

No

G/TBT/N/JPN/505

Country JAPAN

Product Motorcycles (including mopeds) and cycles fitted with an auxiliary motor, with or without side-

cars; side-cars (HS: 8711)

Title The Partial Amendment of "Public Notice that Prescribes Details of Safety Regulations for the

Road Transport Vehicle" (3 pages, in English)

Contents

Amendments to the relevant regulations concerning fuel system of a motor vehicle for the

highly compressed gas fuel mainly in order to new provisions to the safety regulations for

compressed hydrogen fuel cell motorcycles in case of coalition accident to avoid explosion of

hydrogen receptacle.

Last Date

for

Comment


45TBT

Notification G/TBT/N/KEN/453

No

Country KENYA

Product Surface preparation (ICS: 25.220.10)

Title DKS 1100:2015. Scouring Pads – Specification (7 pages, in English)

Contents

This second edition of this standard has considered revision of the scope to exclude scouring

pads for specialized uses e.g. non-scratch scouring pads for delicate surfaces and scouring

pads for heavy duty use. Substance has been revised to 500g/m2 minimum for all grades,

colour fastness to 4-5, breaking load to 80 minimum. An alternative method for determining

abrasive strength was introduced, the Schiefer Test. It specifies requirements and test methods

for scouring pads for household cleaning.

Last Date

for

Comment

22 December 2015

46

TBT

Notification

No

G/TBT/N/TUR/68

Country TURKEY

Product Tomatoes and red pepper paste and puree

Title Turkish Food Codex Communiqué Amending the Communiqué on Tomatoes and Red Pepper

Paste and Puree (2 pages, in Turkish)

Contents

This amendment provides for:

• The definition of tomato and red pepper paste mixed • The mixed paste properties • Lemon and lime juice concentrate to join the products covered in this Communiqué

The revised criteria for total acidity and pH in red pepper paste

Last Date

for

Comment

1 December 2015

47

TBT

Notification

No

G/TBT/N/CHE/209

Country SWITZERLAND

Product

Water heaters; refrigerators; household lamps; washing machines; tumble driers; ovens; standby

and off mode of electrical and electronic household and office equipment; set-top-boxes;

external power supplies; televisions; fluorescent lamps; directional lamps, light emitting diode

lamps and related equipment; air conditioners and comfort fans; household dishwashers;

vacuum cleaners; professional refrigerated storage cabinets, blast cabinets, condensing units and

process chillers; range hoods; space heaters and combination heaters; ventilation units; cars;

coffee machines.

Title Draft revision of the Ordinance on Energy, Annexes 1.7, 2.1-2.5, 2.7-2.9, 2.11, 2.12, 2.14, 2.15,

2.18, 2.20, 2.21, 2.23-2.26, 3.3bis, 3.6, 3.9; 52 pages; available in German, French and Italian.

Contents

Out of the products listed under nr. 4 above, the proposed new regulation would set new

efficiency requirements for following electrical appliances: professional refrigerated storage

cabinets, blast cabinets, condensing units and process chillers; range hoods; space heaters and

combination heaters; ventilation units. It is also foreseen to tighten existing minimum

efficiency requirements for some of the electrical appliances listed above. For other

appliances, as well as for cars, it is only foreseen to change the labelling requirements.

Last Date 8 February 2016

for

Comment

48TBT

Notification

No



G/TBT/N/YEM/26



Product Hard candy (ICS: 67.180)

Title Hard Candy (8 pages, in Arabic only)

Contents GSO 263:2009 for Hard Candy will be amended (amendments highlighted in red) to include

items on the requirements of hard candy manufactured or mainly directed to children.19

Last Date

for

Comment


49

TBT

Notification

No



G/TBT/N/YEM/27



Product Jelly candy (ICS: 67.180)

Title Jelly Candy (5 pages, in English; 8 pages, in Arabic)

Contents GSO 1404:2011 for jelly candy will be amended to include items on the requirements of jelly

candy manufactured or mainly directed to children.

Last Date

for

Comment


50

TBT

Notification

No



G/TBT/N/YEM/28



Product Soft candy (ICS: 67.180)

Title Soft candy (8 pages, in English; 11 pages, in Arabic)

Contents GSO 1320:2014 for soft candy will be amended (amendments highlighted in red) to include

items on the requirements of hard candy manufactured or mainly directed to children.

Last Date

for

Comment


51

TBT

Notification

No

G/TBT/N/EU/326


Product Cellulose insulation mixtures and articles containing inorganic ammonium salts

Title

Draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the

European Parliament and of the Council concerning the Registration, Evaluation, Authorisation

and Restriction of Chemicals (REACH) as regards inorganic ammonium salts (4 pages + Annex

2 pages, in English)

Contents

This draft Regulation relates to a new entry (65) of Annex XVII to Regulation (EC) No

1907/2006.

The new entry would restrict the placing on the market and use of cellulose insulation

mixtures and articles containing inorganic ammonium salts. A limit value (3 ppm by volume)

would be introduced to regulate the maximum emission of ammonia from the cellulose

insulation under certain conditions. Additionally, compliance with the maximum loading rate

used in the test done prior to marketing is required when cellulose insulation mixtures are

used, in order to ensure that the ammonia emission limit is not exceeded. The maximum

loading rate should be communicated by the supplier of the cellulose insulation mixture to

recipients or end users. An exemption would be made for cellulose insulation mixtures

containing inorganic ammonium salts that are only used for the production of cellulose

insulation articles, since the resulting articles themselves need to comply with the ammonia

emission limit prior to their placing on the market and use.

The application of the restriction is deferred for two years to allow industry sufficient time to

comply with the obligations described above. However, in the territory of a Member State

that already has in place national measures restricting ammonium salts in cellulose insulation

that have been authorised by the Commission pursuant to the REACH safeguard procedure,

the restriction would apply immediately.

Last Date

for

Comment


52

TBT

Notification

No

G/TBT/N/JPN/506

Country JAPAN

Product

The following chemical substances:

1. Polychlorinated naphthalenes containing two chlorine atoms 2. Pentachlorophenol and its salts and esters

The following products in which polychlorinated naphthalenes containing two chlorine atoms

are used:

1. Lubricating and cutting oils 2. Wood antiseptics, insecticides, and fungicides 3. Paints (limited to those for antiseptic, insecticidal, and fungicidal use)

The following products in which pentachlorophenol and its salts and esters are used:

1. Wood antiseptics, insecticides, and fungicides 2. Wood treated with antiseptics, insecticides, and fungicides 3. Plywood treated with antiseptics, insecticides, and fungicides

Glues

Title Revision of the "Order for Enforcement of the Act on the Evaluation of Chemical Substances

and Regulation of Their Manufacture, etc." (2 pages, in English)

Contents

Based on Article 17 and 22 of Act on the Evaluation of Chemical Substances and Regulation

of Their Manufacture, etc. (hereinafter referred to as "the Act"), the following will be

designated as Class I Specified Chemical Substances which need authorization to

manufacture or import.

1. Polychlorinated naphthalenes containing two chlorine atoms 2. Pentachlorophenol and its salts and esters

Based on Article 24 of the Act, the following will be designated as products prohibited from

importation when polychlorinated naphthalenes containing two chlorine atoms are used in

them.

1. Lubricating and cutting oils 2. Wood antiseptics, insecticides, and fungicides 3. Paints (limited to those for antiseptic, insecticidal, and fungicidal use)

Also, the following will be designated as products prohibited from importation when

pentachlorophenol and its salts and esters are used in them.

1. Wood antiseptics, insecticides, and fungicides 2. Wood treated with antiseptics, insecticides, and fungicides 3. Plywood treated with antiseptics, insecticides, and fungicides

Glues

Last Date

for

Comment


TBT

Notification

No

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Notification

No

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Contents

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for

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Notification

No

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for

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Notification

No

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Contents

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for

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Notification

No

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Contents

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for

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TBT

Notification

No

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Contents

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for

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TBT

Notification

No

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for

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Notification

No

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Contents

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for

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TBT

Notification

No

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Contents

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for

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TBT

Notification

No

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Contents

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for

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TBT

Notification

No

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Contents

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for

Comment

TBT ABSTRACTS FOR THE 01-11-2015 To 30-11-2015 …€¦ · TBT ABSTRACTS FOR THE 01-11-2015 To...

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