Regulatory Updates

Draft Regulation on The Production, Import, Export and Marketing of Organic, Organomineral Fertilizers and Soil Amendment Products and Microbial, Enzyme Based and Other Products Used in Agriculture(38 pages in Turkish).

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Distribution date: 27 July 2012 | Final date for Comment: 25 September 2012

This regulation is a general revision on the regulation in force (dated 04/06/2010 and Official Gazette No. 27061) due to improvements in technology and market requirements. The regulation covers the promotion, definition, maintaining of analysis methods, production, import, export and marketing of organic, organomineral fertilizers, soil amendment products and other products, microbial and enzyme based products in order to protect consumers, to improve soil fertility and quality, to protect human health and environment. The regulation defines the norms, content and features of the products.

Products Covered: Organic, organomineral fertilizers, soil amendment products, microbial and enzyme based products and other products (HS : 3101)

Regulation Type: Revision to Regular Notification

Draft Regulation on The Production, Import, Export and Marketing of Organic, Organomineral Fertilizers and Soil Amendment Products and Microbial, Enzyme Based and Other Products Used in Agriculture(38 pages in Turkish).

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Distribution date: 27 July 2012 | Final date for Comment: 25 September 2012

This regulation is a general revision on the regulation in force (dated 04/06/2010 and Official Gazette No. 27061) due to improvements in technology and market requirements. The regulation covers the promotion, definition, maintaining of analysis methods, production, import, export and marketing of organic, organomineral fertilizers, soil amendment products and other products, microbial and enzyme based products in order to protect consumers, to improve soil fertility and quality, to protect human health and environment. The regulation defines the norms, content and features of the products.

Products Covered: Organic, organomineral fertilizers, soil amendment products, microbial and enzyme based products and other products (HS : 3101)

Regulation Type: Revision to Regular Notification

Resolución Directoral Nº 009-2012-AG-SENASA-DSV (Directorial Resolution No. 009-2012-AG-SENASA-DSV)

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Distribution date: 19 July 2012

The notified Directorial Resolution establishes the mandatory phytosanitary requirements governing the importation into Peru from the United Kingdom for research purposes of nucleic acid (DNA) extractions from Ralstonia solanacearum and freeze-dried samples infected with potato spindle tuber viroid (PSTVd).

Products Covered: HS tariff subheading 3002.90.10.00: Micro-organisms.

Regulation Type: Regular notification

Plant health Pests Bacteria

Resolución Directoral Nº 009-2012-AG-SENASA-DSV (Directorial Resolution No. 009-2012-AG-SENASA-DSV)

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Distribution date: 19 July 2012

The notified Directorial Resolution establishes the mandatory phytosanitary requirements governing the importation into Peru from the United Kingdom for research purposes of nucleic acid (DNA) extractions from Ralstonia solanacearum and freeze-dried samples infected with potato spindle tuber viroid (PSTVd).

Products Covered: HS tariff subheading 3002.90.10.00: Micro-organisms.

Regulation Type: Regular notification

Plant health Pests Bacteria

TITLE: D&C Red No. 6 and D&C Red No. 7; Change in Specification ; ; AGENCY: Food and Drug Administration (FDA), Health and Human Services (HHS) ; ; ACTION: Final Rule ; ; SUMMARY: The Food and Drug Administration (FDA or the Agency) is revising its requirements for D&C Red No. 6 and D&C Red No. 7 by replacing the current specification for “Ether-soluble matter” with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4-methylphenyl)azo]-2-naphthalenol. This action is in response to a petition filed by Sun Chemical Corp. ; ; DATES: This rule is effective 7 August 2012, except as to any provisions that may be stayed by the filing of proper objections. Submit either electronic or written objections and requests for a hearing by 6 August 2012. See section XI of this document for information on the filing of objections. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-07-06/html/2012-16581.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-07-06/pdf/2012-16581.pdf ;

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Distribution date: 19 July 2012

Products Covered: Drugs and cosmetics (color additives) (HS 3304; ICS 71.100)

Regulation Type: Addendum to Regular Notification

TITLE: D&C Red No. 6 and D&C Red No. 7; Change in Specification ; ; AGENCY: Food and Drug Administration (FDA), Health and Human Services (HHS) ; ; ACTION: Final Rule ; ; SUMMARY: The Food and Drug Administration (FDA or the Agency) is revising its requirements for D&C Red No. 6 and D&C Red No. 7 by replacing the current specification for “Ether-soluble matter” with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4-methylphenyl)azo]-2-naphthalenol. This action is in response to a petition filed by Sun Chemical Corp. ; ; DATES: This rule is effective 7 August 2012, except as to any provisions that may be stayed by the filing of proper objections. Submit either electronic or written objections and requests for a hearing by 6 August 2012. See section XI of this document for information on the filing of objections. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-07-06/html/2012-16581.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-07-06/pdf/2012-16581.pdf ;

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Distribution date: 19 July 2012

Products Covered: Drugs and cosmetics (color additives) (HS 3304; ICS 71.100)

Regulation Type: Addendum to Regular Notification

Resolución Directoral Nº 0014-2012-AG-SENASA-DSV (Directorial Resolution No. 0014-2012-AG-SENASA-DSV)

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Distribution date: 18 July 2012

The notified Directorial Resolution establishes the mandatory phytosanitary requirements governing the importation of cultures of microorganisms (Rhizophagus intraradices) from Germany for research purposes.

Products Covered: HS tariff subheading 3002.90.10.00: Microorganisms

Regulation Type: Regular notification

Pests Pest- or Disease- free Regions / Regionalization Plant health Adoption/publication/entry into force of reg. Bacteria

Resolución Directoral Nº 0014-2012-AG-SENASA-DSV (Directorial Resolution No. 0014-2012-AG-SENASA-DSV)

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Distribution date: 18 July 2012

The notified Directorial Resolution establishes the mandatory phytosanitary requirements governing the importation of cultures of microorganisms (Rhizophagus intraradices) from Germany for research purposes.

Products Covered: HS tariff subheading 3002.90.10.00: Microorganisms

Regulation Type: Regular notification

Pests Pest- or Disease- free Regions / Regionalization Plant health Adoption/publication/entry into force of reg. Bacteria

Proposed Amendment to the Pest Control Products Regulations

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Distribution date: 17 July 2012 | Final date for Comment: 20 July 2012

The Pest Control Products Act (PCPA) and the Pest Control Product Regulations (PCPR) provide the legislative mandate to regulate pest control products in Canada. Under the PCPA, the Minister has the authority to allow the use of unregistered pest control products (i.e. a pest control product that is not registered in Canada), if the use of such products does not pose any unacceptable health or environmental risks. Using this authority, provisions in the Pest Control Products Regulations currently allow the importation of a foreign product, exempt from Canadian registration requirements, provided it is deemed to be equivalent to a Canadian registered product and has an equivalent label. The proposed amendments are intended to formalize the existing approach to establishing equivalence between registered and foreign products as well as to simplify certain administrative aspects of the program. The proposed amendments, consistent with the existing program, would clarify the process by which chemical equivalence is determined between a registered Canadian product and a foreign (unregistered) product. The establishment of chemical equivalence is crucial since it helps ensure that the importation of a product under regulation does not present unacceptable health or environmental risks. Also consistent with the existing program, the amendments empower grower groups with the responsibility to nominate products for importation and to define the conditions that growers must meet in order to import products into Canada. Note: This document has also been notified under the TBT Agreement.

Products Covered: Pest control products (ICS Code: 65.100)

Regulation Type: Regular notification

Food safety Labelling Human health Pesticides

Proposed Amendment to the Pest Control Products Regulations

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Distribution date: 17 July 2012 | Final date for Comment: 20 July 2012

The Pest Control Products Act (PCPA) and the Pest Control Product Regulations (PCPR) provide the legislative mandate to regulate pest control products in Canada. Under the PCPA, the Minister has the authority to allow the use of unregistered pest control products (i.e. a pest control product that is not registered in Canada), if the use of such products does not pose any unacceptable health or environmental risks. Using this authority, provisions in the Pest Control Products Regulations currently allow the importation of a foreign product, exempt from Canadian registration requirements, provided it is deemed to be equivalent to a Canadian registered product and has an equivalent label. The proposed amendments are intended to formalize the existing approach to establishing equivalence between registered and foreign products as well as to simplify certain administrative aspects of the program. The proposed amendments, consistent with the existing program, would clarify the process by which chemical equivalence is determined between a registered Canadian product and a foreign (unregistered) product. The establishment of chemical equivalence is crucial since it helps ensure that the importation of a product under regulation does not present unacceptable health or environmental risks. Also consistent with the existing program, the amendments empower grower groups with the responsibility to nominate products for importation and to define the conditions that growers must meet in order to import products into Canada. Note: This document has also been notified under the TBT Agreement.

Products Covered: Pest control products (ICS Code: 65.100)

Regulation Type: Regular notification

Food safety Labelling Human health Pesticides

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