Regulatory Updates

Distribution date: 08 January 2014 | Final date for Comment: 09 March 2014

Enactment of the Enforcement Decree of Testing and Inspection of Food and Drugs Act. The key features of the Enforcement Decree include: - Organization and operation of steering committee and working committee in the Testing and Inspection Food and Drugs Act. - Establishment and management of the Laboratory Information Management System (LIMS) - Designation of organizations engaged in research and development of testing and inspection systems - Establishment of the basis for imposing penalty charges as an alternative to suspending laboratory services - Matters regarding delegation of authority from the Minister of MFDS to the Commissioner of regional KFDA

Products Covered: Testing laboratories (food, livestock product, drug, traditional Korean medicinal substance, medical device, cosmetics)

Regulation Type: Regular notification

Distribution date: 08 January 2014 | Final date for Comment: 09 March 2014

Enactment of the Enforcement Regulation of Testing and Inspection of Food and Drugs Act. The key features of the Enforcement Regulation include: - Establishment of standards and procedures for the designation, change of designation status and validity period of testing laboratories - Establishment of standards and procedures for the designation, change of designation status of Foreign Official Laboratories - Establishment of standards and procedures for the succession of laboratory's representative - Establishment of the basis of service suspension of MFDS-designated testing laboratories (including Foreign Official Laboratories) - Matters regarding test standards and methods, storage and report of rejected test samples - Establishment of standards and procedures in accordance of international standards regarding the designation, change of designation status of Good Testing Laboratory - Matters regarding proficiency testing programmes - Matters regarding fees charged for the designation, change of designation status of testing laboratories and training institutes

Products Covered: Testing laboratories (food, livestock product, drug, traditional Korean medicinal substance, medical device, cosmetics)

Regulation Type: Regular notification

Distribution date: 08 January 2014 | Final date for Comment: 09 March 2014

Enactment of the Enforcement Regulation of Testing and Inspection of Food and Drugs Act. The key features of the Enforcement Regulation include: - Establishment of standards and procedures for the designation, change of designation status and validity period of testing laboratories - Establishment of standards and procedures for the designation, change of designation status of Foreign Official Laboratories - Establishment of standards and procedures for the succession of laboratory's representative - Establishment of the basis of service suspension of MFDS-designated testing laboratories (including Foreign Official Laboratories) - Matters regarding test standards and methods, storage and report of rejected test samples - Establishment of standards and procedures in accordance of international standards regarding the designation, change of designation status of Good Testing Laboratory - Matters regarding proficiency testing programmes - Matters regarding fees charged for the designation, change of designation status of testing laboratories and training institutes

Products Covered: Testing laboratories (food, livestock product, drug, traditional Korean medicinal substance, medical device, cosmetics)

Regulation Type: Regular notification

Distribution date: 06 January 2014

The Russian Federation notified the draft of the Eurasian Economic Commission Collegium Decision on amendments to the CU Commission Decision on application of international standards, recommendations and guidelines No. 721 as of 22 June 2011 in G/SPS/N/RUS/31 (29 August 2013). The notified draft proposal is withdrawn.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 06 January 2014

The Russian Federation notified the draft of the Eurasian Economic Commission Collegium Decision on amendments to the CU Commission Decision on application of international standards, recommendations and guidelines No. 721 as of 22 June 2011 in G/SPS/N/RUS/31 (29 August 2013). The notified draft proposal is withdrawn.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 20 December 2013

The notified Technical Regulation lays down the requirements for the registration of fertilizers and soil conditioners for agricultural use.It applies to the registration of agricultural fertilizers and soil conditioners which are manufactured, formulated, extracted from natural sources, packaged, repacked/repackaged, imported, exported, distributed and marketed in countries of the Central American region.It does not apply to special fertilizer formulas that are used by the same country in which they are produced. The use of such formulas shall be regulated in accordance with the existing legislation of each Central American country.http://members.wto.org/crnattachments/2013/sps/CRI/13_4971_00_s.pdf(Final version)

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 20 December 2013

The notified Technical Regulation lays down the requirements for the registration of fertilizers and soil conditioners for agricultural use.It applies to the registration of agricultural fertilizers and soil conditioners which are manufactured, formulated, extracted from natural sources, packaged, repacked/repackaged, imported, exported, distributed and marketed in countries of the Central American region.It does not apply to special fertilizer formulas that are used by the same country in which they are produced. The use of such formulas shall be regulated in accordance with the existing legislation of each Central American country.http://members.wto.org/crnattachments/2013/sps/CRI/13_4971_00_s.pdf(Final version)

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 19 December 2013

Letter by the Federal Service for Veterinary and Phytosanitary Supervision introduces a temporary restriction due to the outbreak of low pathogenic avian influenza on the territory of Ten Boer municipality, Groningen province, the Netherlands. This measure applies to import of live poultry, hatching eggs, fluff and feather, poultry and poultry products meat, which were not heat treated (no less than 70°C), feed and feed additives for poultry (except feed additives of chemical and microbiological synthesis), equipment previously used for maintenance, slaughter and cutting of poultry.

Products Covered: Live poultry, hatching eggs, fluff and feather, poultry and poultry products meat, feed and feed additives for poultry, equipment previously used for maintenance, slaughter and cutting of poultry

Regulation Type: Emergency notifications (SPS)

Distribution date: 19 December 2013

Letter by the Federal Service for Veterinary and Phytosanitary Supervision introduces a temporary restriction due to the outbreak of low pathogenic avian influenza on the territory of Ten Boer municipality, Groningen province, the Netherlands. This measure applies to import of live poultry, hatching eggs, fluff and feather, poultry and poultry products meat, which were not heat treated (no less than 70°C), feed and feed additives for poultry (except feed additives of chemical and microbiological synthesis), equipment previously used for maintenance, slaughter and cutting of poultry.

Products Covered: Live poultry, hatching eggs, fluff and feather, poultry and poultry products meat, feed and feed additives for poultry, equipment previously used for maintenance, slaughter and cutting of poultry

Regulation Type: Emergency notifications (SPS)

Distribution date: 17 December 2013

Declaration of a state of phytosanitary emergency owing to the presence of the pests known as boisduval scale, Diaspis boisduvalii, and banana mealybug, Pseudococcus elisae, in view of the economic damage they cause and the threat they represent to the Costa Rican banana industry.Executive Decree No. 38008 was published in Official Journal La Gaceta No. 236 of 6 December 2013.

Products Covered: Bananas, including plantains, fresh or dried (HS tariff subheading 0803.00)

Regulation Type: Emergency notifications (SPS)