Regulatory Updates
Proyecto de Decreto "Por el cual se reglamenta la fabricación, comercialización, envase, rotulado o etiquetado, régimen de registro sanitario, de control de calidad, de vigilancia sanitaria y control sanitario de los productos de uso específico y se dictan otras disposiciones"
Distribution date: 01 November 2007 | Final date for Comment: 28 February 2008
Products which contain elements which may be aids to maintaining the metabolic processes of the organism
Products Covered:
Regulation Type: Addendum to Regular Notification
Proposed Amendments to the Imported Game, Meat and Poultry Regulations
Distribution date: 30 October 2007 | Final date for Comment: 29 December 2007
To amend the Imported Game, Meat and Poultry Regulations by : (a) requiring import permit/licence and health certificate for poultry eggs (including shell eggs and egg yolks, but excluding egg or egg yolk in liquid or powder form) imported for human consumption; and (b) requiring importers and distributors of game, meat, poultry and poultry eggs (including shell eggs and egg yolks, but excluding egg or egg yolk in liquid or powder form) to register with the FEHD before importing or distributing such food.
Products Covered: Poultry eggs in shell and egg yolks, as well as meat, poultry and game for human consumption
Regulation Type: Revision to Regular Notification
California Assembly Bill (AB) 1108 (2 pages, in English).
Distribution date: 25 October 2007
As of 1 January 2009, the State of California will prohibit the manufacture, sale, or distribution in commerce of certain toys and child care articles, if those products contain types of phthalates in concentrations exceeding 1/10 of 1%. Manufacturers would be required to use the least toxic alternative when replacing phthalates in their products and would be prohibited from replacing phthalates with certain carcinogens and reproductive toxicants.
Products Covered: Children's products, phthalates (HS: 9503, 2917.39, Ch. 95) (ICS: 97.200, 71.080)
Regulation Type: Regular notification
Draft Decree of the Government of the Republic of Armenia on "The Approval of the Technical Regulation on Perfumery and Cosmetics and their Production" (21 pages, in Armenian).
Distribution date: 25 October 2007
This technical regulation sets out the physical and chemical specifications, characterising the safety of the abovementioned perfumery and cosmetic products, as well as the marking, packaging, storing, transportation requirements and conformity assessment procedures for the perfumery and cosmetics.
Products Covered: Perfumery and cosmetic products corresponding to the following coding of HS Nomenclature: - perfumes and toilet waters (3303 00); - beauty and make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen and sun tan preparations, manicure or pedicure preparations (3304); - preparations for use on hair (3305); - preparations for oral or dental hygiene, including denture fixative pastes and powders; yam used to clean between the teeth (dental floss), in individual retail packages (3306); - pre-shave or after-shave preparations (3307 10 000); - personal deodorants and antiperspirants (3307 20 000); - preparations for hair removal (3307 90 000); - hand soap (3401 11 000); - preparations for washing the skin, in the form of liquid or cream (3401 30 000)
Regulation Type: Regular notification
Draft revision of the Ordinance of the Department of Home Affairs concerning the addition of essential or physiologically beneficial substances to foods
Distribution date: 08 October 2007 | Final date for Comment: 10 December 2007
Harmonisation of the Swiss legislation with the corresponding EC regulation (Regulation (EC) No. 1925/2006 on the addition of vitamins and minerals in certain other substances to food)
Products Covered: Food and basic commodities
Regulation Type: Regular notification
Draft Resolution nº 81, 29 August 2007 – Technical Regulation on Terminology for Drug Packaging (5 pages, in Portuguese).
Distribution date: 03 October 2007
Products Covered: Drug Packaging
Regulation Type: Regular notification
Notice of Intent to Adopt Regulations and to Revise the State Implementation Plan for Air Quality (2 pages, in English).
Distribution date: 27 September 2007
The State of Connecticut intends to limit emissions of volatile organic compounds (VOCs) from the use of adhesives, sealants, primers and solvents. The proposed regulation achieves VOC reductions through sale and manufacture restrictions that limit the VOC content of specified adhesives, sealants and primers sold in the State of Connecticut and use restrictions that apply primarily to commercial/industrial operations. All interested persons are invited to comment on the proposal
Products Covered: Adhesives, sealants, primers, solvents (HS: 29; ICS: 13.020)
Regulation Type: Regular notification
Non-agglutinating antibody vaccine against bovine Brucellosis
Distribution date: 12 September 2007
The Draft Normative Instruction notified as G/SPS/N/BRA/226 (criteria for the use of non-agglutinating antibody vaccines against bovine Brucellosis) was adopted as a final text, published as Normative Instruction Nº 33, on 24 August 2007, in the Official Gazette Nº 166 from 28 August 2007, section 1, pages 6 and 7. Date of entry into force: 28 August 2007. The full text is available only in Portuguese and can be downloaded at: http://extranet.agricultura.gov.br/sislegis-consulta/consultarLegislacao.do?operacao=visualizar&id=18064 E-mail: cgomc@agricultura.gov.br
Products Covered:
Regulation Type: Addendum to Regular Notification
Proposed Veterinary Drug Residue Limits in Foods: Ractopamine
Distribution date: 05 September 2007
With regard to the notification G/SPS/N/TPKM/114 dated 16 August 2007, the dates of adoption and entry into force of the proposed veterinary drug residue limits of ractopamine in foods have been extended until the time to be decided later.
Products Covered:
Regulation Type: Addendum to Regular Notification
Final Rule; Food Additives Permitted for Direct Addition to Food for Human Consumption; Glycerol Ester of Tall Oil Rosin
Distribution date: 03 September 2007 | Final date for Comment: 20 September 2007
The US Food and Drug Administration (FDA) published a final rule in the Federal Register on August 22, 2007 (72 FR 46895), amending the food additive regulations in §172.735 (21 CFR 172.735) to provide for the safe use of glycerol ester of tall oil rosin to adjust the density of citrus oils used in the preparation of beverages. The additive may be used at a level not to exceed 100 ppm of the finished beverage and will be a substitute for glycerol ester of wood or gum rosin, which are already permitted for this use. The rule also amended §172.735 by providing for the use of steam stripping as a purification method for producing glycerol ester of wood rosin, gum rosin, or tall oil rosin. This action is in response to a petition from Georgia-Pacific Resins, Inc. The complete text of the Final Rule in the Federal Register, 72 FR 46895 (available in English), can be found on the Internet at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-16558.pdf. Any person who will be adversely affected by this regulation may file written or electronic objections and requests for a hearing with the Division of Dockets Management by 20 September 2007. Submit written objections and requests for a hearing identified by Docket No. 2006F-0059, by any of the following methods: . Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. . Agency Web site: http://www.fda.gov/dockets/ecomments. Follow the instructions for submitting comments on the agency Web site. . Fax: 301-827-6870 . Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All submissions received must include the agency name and docket number for this rulemaking. All objections received will be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided. For further information contact: Blondell Anderson, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1304.
Products Covered:
Regulation Type: Addendum to Regular Notification
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