Regulatory Updates

Distribution date: 24 February 2011

Products Covered: Hydraulic brake fluids for automotive vehicles (HS 381900)

Regulation Type: Addendum to Regular Notification

Distribution date: 24 February 2011

Products Covered: Hydraulic brake fluids for automotive vehicles (HS 381900)

Regulation Type: Addendum to Regular Notification

Distribution date: 22 February 2011

The Republic of Colombia hereby notifies that the draft Resolution of the Colombian Agricultural Institute (ICA) "Laying down requirements for the registration of efficacy trial technical departments and producers and importers of agricultural bio-inputs and adopting other provisions", notified on 29 March 2010 by the World Trade Organization in document G/SPS/N/COL/188, was issued on 4 February 2011, pursuant to Colombian Agricultural Institute Resolution No. 000698.Text available online at: http://members.wto.org/crnattachments/2011/sps/COL/11_0557_00_s.pdf

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 22 February 2011

The Republic of Colombia hereby notifies that the draft Resolution of the Colombian Agricultural Institute (ICA) "Laying down requirements for the registration of efficacy trial technical departments and producers and importers of agricultural bio-inputs and adopting other provisions", notified on 29 March 2010 by the World Trade Organization in document G/SPS/N/COL/188, was issued on 4 February 2011, pursuant to Colombian Agricultural Institute Resolution No. 000698.Text available online at: http://members.wto.org/crnattachments/2011/sps/COL/11_0557_00_s.pdf

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 11 February 2011 | Final date for Comment: 12 April 2011

This draft of decree states that all of Rubber seals for LPG steel cylinder valve products produced within the country or imported, distributed and marketed in the country shall fulfil the SNI requirements. The producers which produced these products therefore shall comply with the requirements of SNI proven by having Product Certificate for Using SNI Mark and put SNI mark on every Rubber seals for LPG steel cylinder valve product. ; The product certificate on SNI marking shall be issued by a Product Certification Body which has been designated by the Minister of Industry through: ; a. Testing of the conformity of the products quality against SNI requirements; and ; b. Audit on the implementation of the Quality Management System (QMS) SNI ISO 9001:2008 or its revision; or other recognized Quality Management System. ; ; Directorate General Manufactured Based Industry, Ministry of Industry is the institution that is responsible for the implementation of this decree and shall provide a technical guidance of the decree, which cover procedure of Product Certification and SNI Marking. ; Products which are distributed in domestic market that originated domestically and imported shall meet the requirements consisted in SNI 7655:2010, Rubber seals for LPG steel cylinder valve , which specify term and definition, quality requirements, sampling, testing method, testing acceptance, marking requirement and packaging (this standard is available in Indonesian language). ;

Products Covered: Rubber seals for LPG steel cylinder valve (SNI 7655:2010), HS 4016.93.90.00 ; ;

Regulation Type: Regular notification

Distribution date: 11 February 2011 | Final date for Comment: 12 April 2011

This draft of decree states that all of Rubber seals for LPG steel cylinder valve products produced within the country or imported, distributed and marketed in the country shall fulfil the SNI requirements. The producers which produced these products therefore shall comply with the requirements of SNI proven by having Product Certificate for Using SNI Mark and put SNI mark on every Rubber seals for LPG steel cylinder valve product. ; The product certificate on SNI marking shall be issued by a Product Certification Body which has been designated by the Minister of Industry through: ; a. Testing of the conformity of the products quality against SNI requirements; and ; b. Audit on the implementation of the Quality Management System (QMS) SNI ISO 9001:2008 or its revision; or other recognized Quality Management System. ; ; Directorate General Manufactured Based Industry, Ministry of Industry is the institution that is responsible for the implementation of this decree and shall provide a technical guidance of the decree, which cover procedure of Product Certification and SNI Marking. ; Products which are distributed in domestic market that originated domestically and imported shall meet the requirements consisted in SNI 7655:2010, Rubber seals for LPG steel cylinder valve , which specify term and definition, quality requirements, sampling, testing method, testing acceptance, marking requirement and packaging (this standard is available in Indonesian language). ;

Products Covered: Rubber seals for LPG steel cylinder valve (SNI 7655:2010), HS 4016.93.90.00 ; ;

Regulation Type: Regular notification

Distribution date: 08 February 2011 | Final date for Comment: 09 April 2011

Description of Content: The Food and Drug Administration (FDA) is taking steps to reduce the maximum dosage unit strength of acetaminophen in prescription drug products. This change will provide an increased margin of safety to help prevent liver damage due to acetaminophen overdosing, a serious public health problem. This notice explains the reasons for the reduction in dosage unit strength and describes how FDA is implementing it for approved prescription drug products that exceed the new maximum tablet or capsule strength. FDA is also requiring safety labeling changes, including a new boxed warning, for acetaminophen-containing prescription drug products to address new safety information about the risk of liver damage. ; NOTE: Sponsors of approved prescription drug products containing more than 325 milligrams (mg) of acetaminophen have until 14 January 2014 to request that FDA withdraw approval of the product's application, after which they may be subject to action by FDA. ;

Products Covered: ICS numbers may be provided in addition, where applicable): Prescription Drug Products Containing Acetaminophen (HS 3004; ICS 11.120.10)

Regulation Type: Regular notification

Distribution date: 08 February 2011 | Final date for Comment: 09 April 2011

Description of Content: The Food and Drug Administration (FDA) is taking steps to reduce the maximum dosage unit strength of acetaminophen in prescription drug products. This change will provide an increased margin of safety to help prevent liver damage due to acetaminophen overdosing, a serious public health problem. This notice explains the reasons for the reduction in dosage unit strength and describes how FDA is implementing it for approved prescription drug products that exceed the new maximum tablet or capsule strength. FDA is also requiring safety labeling changes, including a new boxed warning, for acetaminophen-containing prescription drug products to address new safety information about the risk of liver damage. ; NOTE: Sponsors of approved prescription drug products containing more than 325 milligrams (mg) of acetaminophen have until 14 January 2014 to request that FDA withdraw approval of the product's application, after which they may be subject to action by FDA. ;

Products Covered: ICS numbers may be provided in addition, where applicable): Prescription Drug Products Containing Acetaminophen (HS 3004; ICS 11.120.10)

Regulation Type: Regular notification

Distribution date: 07 February 2011 | Final date for Comment: 08 April 2011

This draft GSO technical regulation applies to salt used as an ingredient of food, the requirements under clauses 10 & 11 (packaging & labeling) are mandatory requirements. It specifies that: ; • Iodised salt should be packed in air tight bags of either high density polyethylene (HDPE) or polypropylene (PP) (laminated or non-laminated) or LDPE-lined jute bags (Grade 1803 DW jute bags lined with 150 gauge polyethylene sheet). ; • Bulk packing units should not exceed 50 kg. ; • Bags that have already been used for packing other articles such as fertilizers, cement, chemicals, etc. Should not be reused for packing iodised salt. ; It describes label requirements such as : ; ; • The name of the product, as declared on the label shall be "salt". ; • The name "salt" shall have in its close proximity a declaration of either "Food Grade" or "Cooking Salt" or "Table Salt". ; • Only when salt contains one or more ferrocyanide salts, added to the brine during the crystallization step, the term "dendritic" could be included accompanying the name. ; • Where salt is used as a carrier for one or more nutrients, and sold as such for public health reasons, the name of the product shall be declared properly on the label, for example "salt fluoridated", "salt iodated", "salt iodized", "salt fortified with iron", "salt fortified with vitamins" and so on, as appropriate. ;

Products Covered: Food Grade Salt , HS 25 01 00 10

Regulation Type: Regular notification

Distribution date: 07 February 2011 | Final date for Comment: 08 April 2011

This draft GSO technical regulation applies to salt used as an ingredient of food, the requirements under clauses 10 & 11 (packaging & labeling) are mandatory requirements. It specifies that: ; • Iodised salt should be packed in air tight bags of either high density polyethylene (HDPE) or polypropylene (PP) (laminated or non-laminated) or LDPE-lined jute bags (Grade 1803 DW jute bags lined with 150 gauge polyethylene sheet). ; • Bulk packing units should not exceed 50 kg. ; • Bags that have already been used for packing other articles such as fertilizers, cement, chemicals, etc. Should not be reused for packing iodised salt. ; It describes label requirements such as : ; ; • The name of the product, as declared on the label shall be "salt". ; • The name "salt" shall have in its close proximity a declaration of either "Food Grade" or "Cooking Salt" or "Table Salt". ; • Only when salt contains one or more ferrocyanide salts, added to the brine during the crystallization step, the term "dendritic" could be included accompanying the name. ; • Where salt is used as a carrier for one or more nutrients, and sold as such for public health reasons, the name of the product shall be declared properly on the label, for example "salt fluoridated", "salt iodated", "salt iodized", "salt fortified with iron", "salt fortified with vitamins" and so on, as appropriate. ;

Products Covered: Food Grade Salt , HS 25 01 00 10

Regulation Type: Regular notification