Regulatory Updates
Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D and Osteoporosis
Distribution date: 21 November 2008
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Monday, 29 September 2008 (73 FR 56477). The final rule was published with an inadvertent error in the "Analysis of Economic Impacts" section. This document corrects that error. The full text can be viewed at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-26868.pdf, and includes contact information. The correction is effective on 12 November 2008.
Products Covered:
Regulation Type: Corrigendum to Regular Notification
RTCA 65.05.51.08: Medicamentos Veterinarios y Productos Afines, Establecimientos que los Fabrican, Comercializan, Fraccionan o Almacenan. Requisitos de Registro Sanitario y Control (Central American Technical Regulation (RTCA) No. 65.05.51:08: Veterinary drugs and related products, and establishments engaged in the manufacture, marketing, fractioning or storage thereof. Sanitary registration and control requirements) (37 pages, in Spanish).
Distribution date: 21 November 2008 | Final date for Comment: 20 January 2009
The aim of the notified Regulation is to establish provisions governing the sanitary registration and control of veterinary drugs and related products and establishments in this sector. The provisions of this Regulation apply to all food products marketed in Central American countries.
Products Covered: Veterinary drugs and related products (HS Chapter 30; International Classification for Standards (ICS) code 65.020.30)
Regulation Type: Regular notification
Draft Regulations Implementing the Massachusetts Mercury Management Act, Chapter 190 of the Acts of 2006
Distribution date: 21 November 2008 | Final date for Comment: 24 November 2008
The Massachusetts Department of Environmental Protection is proposing regulations that will govern three requirements of the Massachusetts Mercury Management Act: bans on the sale of certain measuring devices and all switches and relays containing mercury; requirements that mercury-added items remaining on the market carry specific labels; and prohibitions on both the disposal of mercury-added products and the collection of solid waste containing them.
Products Covered: Products containing mercury (HS 2805.40) (ICS 13.020, 13.030, 71)
Regulation Type: Regular notification
Agency: Food and Drug Administration (FDA) ; ACTION: Final rule; correction ; Title: Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis ; ; Summary: The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of 29 September 2008 (73 FR 56477). The final rule was published with an error in the “Analysis of Economic Impacts” section. This document corrects that error. ; ; DATES: This correction is effective 12 November 2008
Distribution date: 19 November 2008
Products Covered: Food Labeling (HS: Chapter 2936; ICS: 67.040)
Regulation Type: Addendum to Regular Notification
Title: National Volatile Organic Compound Emission Standards for Aerosol Coatings ; ; AGENCY: Environmental Protection Agency (EPA) ; ; ACTION: Proposed Rule ; ; SUMMARY: EPA is proposing to amend the National Volatile Organic ; Compound Emission Standards for Aerosol Coatings, which establishes ; national reactivity-based emission standards for the aerosol coatings ; category (aerosol spray paints) under the Clean Air Act (CAA). In this ; Rules and Regulations section of this Federal Register, we are ; making these same amendments as a direct final rule, without a prior ; proposed rule. If we receive no adverse comment, we will not take ; further action on this proposed rule. ; ; Comment deadline: 8 December 2008 ;
Distribution date: 19 November 2008
Products Covered: Aerosol spray coatings (HS: 29; ICS: 87.040, 87.060, 71.100, 71.080, 13.020)
Regulation Type: Addendum to Regular Notification
Title: National Volatile Organic Compound Emission Standards for Aerosol Coatings ; ; AGENCY: Environmental Protection Agency (EPA) ; ; ACTION: Direct Final Rule ; ; SUMMARY: EPA is taking direct final action on the National Volatile Organic Compound Emission Standards for Aerosol Coatings, which establishes national reactivity-based emission standards for the aerosol coatings category (aerosol spray paints) under the Clean Air Act (CAA). EPA is moving the applicability and compliance dates for aerosol coatings from 1 January 2009, to 1 July 1 2009. EPA is also making initial notifications required due on the compliance date, as opposed to 90 days in advance of the compliance date. ; ; Effective Date: 1 July 2009 ; ; Comment deadline: 8 December 2008 ; ; ; ; ; ; ;
Distribution date: 19 November 2008
Products Covered: Aerosol spray coatings (HS: 29; ICS: 87.040, 87.060, 71.100, 71.080, 13.020)
Regulation Type: Addendum to Regular Notification
NSO RTCA 65.05.51:08: Medicamentos Veterinarios y Productos Afines, Establecimientos que los Fabrican, Comercializan, Fraccionan o Almacenan. Requisitos de Registro Sanitario y Control (Salvadoran Mandatory Standard (NSO) / Central American Technical Regulation (RTCA) No. 65.05.51:08: Veterinary drugs and related products, and establishments engaged in the manufacture, marketing, fractioning or storage thereof. Sanitary registration and control requirements) (37 pages, in Spanish).
Distribution date: 11 November 2008 | Final date for Comment: 10 January 2009
The aim of the notified Regulation is to establish provisions governing the sanitary registration and control of veterinary drugs and related products and establishments in this sector. This Regulation applies to pharmaceutical products, alternative medicine products, chemicals exclusively for veterinary use or use in livestock facilities, veterinary biologics and animal hygiene and grooming products, as well as to establishments which manufacture, market, fraction or store veterinary drugs and related products in Central American countries.
Products Covered: Pharmaceutical products: HS Chapter 30 (International Classification for Standards (ICS) code 65.020.30)
Regulation Type: Regular notification
Salvadoran Mandatory Standard (NSO) / Central American Technical Regulation (RTCA) No. 65.05.51:08: Veterinary drugs and related products, and establishments engaged in the manufacture, marketing, fractioning or storage thereof. Sanitary registration and control requirements (37 pages, in Spanish).
Distribution date: 06 November 2008 | Final date for Comment: 05 January 2009
The aim of the notified Regulation is to establish provisions governing the sanitary registration and control of veterinary drugs and related products and establishments in this sector. This Regulation applies to all food products marketed in Central American countries.
Products Covered: Pharmaceutical products: HS Chapter 30 (International Classification for Standards (ICS) code 65.020.30)
Regulation Type: Regular notification
Consumer Protection (Compliance With Safety Standards) Regulations 2008 (10 pages, English) and Consumer Protection (Safety Standards For Toys) Regulations 2008 (5 pages, English).
Distribution date: 06 November 2008 | Final date for Comment: 05 January 2009
1. Consumer Protection (Compliance With Safety Standards) Regulations 2008 ; The draft regulations specify the general procedural requirements with regard to safety standards of consumer goods which include the safety and marking requirements, certification of approval, conformity assessment report, offences and penalties, maintenance of records, authorized agency, transitional period for toys which are marketed in Malaysia. ; ; 2. Consumer Protection (Safety Standards For Toys) Regulations 2008 ; The draft regulation states that toys (as defined in the regulations) that are sold or supplied in Malaysia must conform to the specified safety standards. ; ; The safety standards prescribed under these regulations are: ; MS ISO 8124-1, Safety of toys – Part 1: Safety aspects related to mechanical and physical properties; ; MS ISO 8124-2, Safety of toys – Part 2: Flammability; ; MS ISO 8124-3, Safety of toys – Part 3: Migration of certain elements; ; MS 1774: Part 4, Safety of toys – Part 4: Experimental sets for chemistry and related activities; ; MS 1774: Part 5, Safety of toys – Part 5: Chemical toys (sets) other than experimental sets; ; MS 1774: Part 6:, Safety of toys – Part 6: Graphical symbol for age warning labeling; and ; MS 1725, Safety of Electric Toys. ;
Products Covered: Toys (HS: Chapter 95) (ICS: 97.200.50) ; Toys and any goods designed or intended for use in play by children less than fourteen years of age but does not include the goods listed in Schedule I of Consumer Protection (Safety Standards For Toys) Regulations 2008. ;
Regulation Type: Regular notification
Adhesives for tiles: Definitions and specifications.
Distribution date: 04 November 2008 | Final date for Comment: 03 January 2009
The requirements of the existing standard, SI 4004 part 1dealing with adhesives for tiles, will be declared mandatory.
Products Covered: Adhesives for tiles (HS: 3506) (ICS: 83.180).
Regulation Type: Regular notification
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