Normative Instruction N° 34, 28 May 2008

Product Image

Distribution date: 26 June 2008

The notified regulation approves the Technical Regulation of Sanitary and Technologic Inspection of Animal By-Products Processing and the By-Products Transport Form.

Products Covered: Animal by-products

Regulation Type: Regular notification

Animal health

Draft Resolution nº 21, 3 June 2008 – Technical regulation on E11 – etridiazole (2 pages, Portuguese).

Product Image

Distribution date: 24 June 2008

Products Covered: Insecticides, rodenticides, fungicides, herbicides, disinfectants, etc. (HS:  38.08)

Regulation Type: Regular notification

Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients (18 pages, in English).

Product Image

Distribution date: 24 June 2008

The Food and Drug Administration (FDA) is proposing that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective (GRASE) or are misbranded. FDA is proposing that any OTC drug product containing any of these ingredients must be the subject of an approved NDA (New Drug Application).

Products Covered: Drug products (HS:  3004, 1302.19) (ICS:  11.120)

Regulation Type: Regular notification

Regulations to Laws No. 27645, Law Regulating the Marketing of Methyl Alcohol, and No. 28317, Law on the Control and Monitoring of the Marketing of Methyl Alcohol (19 pages, in Spanish).

Product Image

Distribution date: 16 June 2008

The notified draft technical regulations comprise seven (7) sections, seventy (70) articles, two (2) final supplementary provisions, one (1) transitional supplementary provision and six (6) annexes, covering regulatory aspects and procedures in respect of the control and monitoring of methyl alcohol and provisions relating to the labelling of methyl alcohol.

Products Covered: Methanol (methyl alcohol) (HS 2905.11.00.00)

Regulation Type: Regular notification

Draft of Sanitation Standard for Propane to be Used in Food (available in English, 2 pages) http://members.wto.org/crnattachments/2008/sps/TPKM/08_1529_00_e.pdf

Product Image

Distribution date: 29 May 2008

To establish sanitation standard for butane to be used in food.

Products Covered: Propane to be used in food

Regulation Type: Regular notification

Food safety Human health

Proposed Amendments to the California Consumer Products Regulations (73 pages, in English).

Product Image

Distribution date: 19 May 2008

The California Air Resources Board proposes to amend the California rules concerning volatile organic compound (VOC) emissions from consumer products. Adds and modifies product category definitions and establishes new or lower VOC limits for multiple categories. Reduces the use of compounds with high global warming potential in pressurized gas duster products. Proposes to exclude hydrofluoroether 7200 from the VOC definition based on its negligible impacts on ground-level ozone formation. Prohibits the use of toxic air contaminants methylene chloride, perchloroethylene, and trichloroethylene in carpet/upholstery cleaners, fabric protectants, multi-purpose lubricants, penetrants, sealants, caulking compounds and spot removers.

Products Covered: Consumer products (HS:  3402, 13.020, 71.100)

Regulation Type: Regular notification

Definitions and norms for specification, guarantee, tolerance, register, packaging and labelling of mineral fertilizers used in agriculture

Product Image

Distribution date: 19 May 2008

The Ministry of Agriculture, Livestock and Food Supply proposed amendments to the Annexes I, II, VI and VII of the Normative Instruction Nº 5, notified on 22 March 2007 as G/SPS/N/BRA/300 (definitions and norms for specification, guarantee, tolerance, register, packaging and labelling of mineral fertilizers used in agriculture), published as Normative Instruction Nº 21, on 16 April 2008, in the "Diário Oficial da União" Nº 74 (Federal Official Journal) on 17 April 2008, section 1, pages 24, 25, 26, 27 and 28. Date of entry into force: 17 April 2008 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=18587 E-mail: [email protected]

Products Covered:

Regulation Type: Addendum to Regular Notification

Adoption/publication/entry into force of reg.

National Standard of the P.R.C., Water Treatment Chemicals—Polyacrylamide (12 pages, in Chinese)

Product Image

Distribution date: 28 April 2008

Products Covered: Water treatment chemicals—polyacrylamide, HS: 2921.1990.90

Regulation Type: Regular notification

Draft Technical Regulation on safety matches (20 pages, in Spanish).

Product Image

Distribution date: 24 April 2008

The notified draft Technical Regulation contains seventeen (17) articles and four (04) annexes. It establishes the safety, performance and labelling requirements for safety matches and the packaging thereof used, manufactured, imported, marketed or distributed free of charge in Peru.

Products Covered: HS tariff subheading 3605.00.00.00:  Matches, other than pyrotechnic articles of heading 3604

Regulation Type: Regular notification

Use of Materials Derived From Cattle in Human Food and Cosmetics

Product Image

Distribution date: 23 April 2008 | Final date for Comment: 16 July 2008

In an interim final rule published in the Federal Register on 17 April 2008 (73 FR 20785), the US Food and Drug Administration (FDA) is amending its regulations on the use of materials derived from cattle in human food and cosmetics. FDA regulations designate certain materials from cattle as "prohibited cattle materials" and ban the use of such materials in human food, including dietary supplements, and in cosmetics to protect against possible risk for bovine spongiform encephalopathy (BSE). Prohibited cattle materials include specified risk materials (SRMs), the small intestine of all cattle unless the distal ileum is removed, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, or mechanically separated (MS) (Beef). Specified risk materials include the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine of all cattle. These regulations were first published as an interim final rule in the Federal Register on 14 July 2004 (69 FR 42256), and were then amended in a subsequent interim final rule published in the Federal Register on 7 September 2005 (70 FR 53063). In the interim final rule published on 17 April 2008, FDA is amending its regulations so that FDA may designate a country as not subject to certain BSE-related restrictions applicable to FDA regulated human food and cosmetics. A country seeking to be so designated must send a written request to the Director of FDA's Centre for Food Safety and Applied Nutrition, including information about the country's BSE (bovine spongiform encephalopathy) case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other relevant information. Providing this exception will achieve essentially the same protection of public health with fewer restrictions on the market for cattle-derived materials. The amendments to the interim final rule published on 17 April 2008 are effective 16 July 2008. Submit written or electronic comments on this interim final rule by 16 July 2008. All submissions must include the agency name (FDA), Docket No. 2004N-0081 and RIN 0910-AF47, and submitted by any of the following methods: . Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. . 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 comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For additional information on submitting comments, see section IV of the Supplementary Information section of the interim final rule. The amendment to the interim final rule published on 17 April 2008 in the Federal Register (73 FR 20785), can be found at http://www.fda.gov/OHRMS/DOCKETS/98fr/08-1142.pdf. The interim final rule previously published in the Federal Register on 14 July 2004 (69 FR 42256) can be found at: http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15881.pdf. The amendment to the interim final rule published in the Federal Register on 7 September 2005 (70 FR 53063) can be found at: http://www.fda.gov/OHRMS/DOCKETS/98fr/05-17693.pdf. For further information contact: Rebecca Buckner, Centre for Food Safety and Applied Nutrition (HFS-316), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301 436 1486. In addition, United States SPS National Notification Authority may be contacted at USDA Foreign Agricultural Service, International Regulations and Standards Division (IRSD), Stop 1027, Washington D.C. 2025. Tel: +(1 202) 720 1301; Fax: +(1 202) 720 0433; E-mail: [email protected].

Products Covered:

Regulation Type: Addendum to Regular Notification

Animal diseases Food safety Human health Transmissible Spongiform Encephalopathy (TSE) Zoonoses Bovine Spongiform Encephalopathy (BSE)

Submit your email ID to receive notifications about upcoming courses and events